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Development Resource Group

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Category : Quality/Regulatory
Job Type : Contract
Id : 7059
Region : Twin Cities

Seeking a Product Engineer to coordinate and perform much of the work associated with the remediation of Component Specifications and Product BOMs in document management system. This includes requesting, staging, updating, loading, configuring, and entering and managing associated metadata provided by subject matter experts (SMEs).

POSITION RESPONSIBILITIES:

  • Utilize sound engineering judgment to evaluate multiple specifications to create a single master component specification
  • Compare current state and future state documents
  • Follow risk mitigation decision tree
  • Manage individual specifications and collections of related materials
  • Manage the interdependencies between master component specifications and product bill of materials.
  • Manage data for future long term maintenance activities
  • Coordinate input from multiple key stakeholders
  • Work closely with project managers and functional area partners
  • Log activities and progress in task sheet
  • Upload native documents and PDF files into Agile PLM
  • Assist in identification, problem-solving, troubleshooting, and resolution of issues.
  • Escalate challenges quickly for resolution

BASIC QUALIFICATIONS:

  • Bachelor’s Degree
  • Minimum of 2 years of relevant work experience
  • Execution mindset and deadline driven
  • Detail oriented, accurate, and efficient
  • Excellent file management skills
  • Excellent oral and written communications skills
  • Demonstrated ability to manage multiple priorities, often under deadline
  • Technical aptitude to learn new tools
  • Ability to work on a project team or independently
  • Familiarity with enterprise document management systems
  • Familiarity with document control in a regulated environment
  • Mechanical Acumen and the ability to work in CAD package

PREFERRED QUALIFICATIONS:

  • Detail oriented
  • Experience working in a regulated environment
  • Experience working with, and following, required processes and procedures
  • Ability to multi-task and shift priorities effectively and expediently
  • Proficiency with common MS, CAD and Adobe software
  • General understanding of information databases
  • Ability to easily adapt to and master proprietary programs
  • Ability to work independently


Posted: August 17, 2017, 1:18 pm
Category : Mechanical Designer
Job Type : Contract
Id : 7058
Region : Twin Cities

The Mechanical Design Engineer will support the design and post-market support of implantable medical devices. The primary areas of excellence for this position are implementation of product design and design specification improvements. The mechanical design engineer will also review post market product performance and implement improvements to meet reliability, compliance, and cost reduction initiatives. This role also develops technical solutions to problems that require ingenuity and creativity. Applies technical expertise and has knowledge of other related disciplines such as manufacturing and process technologies. Represents the design organization as the primary design contact for continuous improvement, CAPA, and returned product analysis initiatives.

BASIC REQUIREMENTS:

  • B.S. in engineering or appropriate technical discipline
  • Knowledge of manufacturing, clinical, and regulatory requirements
  • Knowledge of engineering statistical tools/methods such as DOE, Monte Carlo, Minitab, ANOVA Experience using and FMEA and FTA methods
  • Proficient with Pro/Engineer software or equivalent CAD software
  • Knowledge of lab practices, procedures, and tools/equipment.

PREFERRED REQUIREMENTS:

  • Minimum of 3 years in either a manufacturing or post-market product development support role, preferably in support of implantable medical devices.
  • Master's Degree in engineering or appropriate technical discipline (Mech. Eng, Materials Science, or equivalent).
  • Experience with CAPA (corrective and preventative action) and continuation projects in a medical device environment.
  • Experience interfacing with physician customers and therapy consultants/sales;
  • Proficient with GD&T tolerance and dimensioning methods and tolerance analysis;
  • Proficient with DFSS principles (VOC, Transfer Functions, etc.) as they relate to designing robust products.
  • DFLS or DFSS Green Belt certification.


Posted: August 17, 2017, 1:05 pm
Category : Quality/Regulatory
Job Type : Contract
Id : 7057
Region : Twin Cities

Seeking a Principal Engineer - Quality Reviewer / Approver for Cleaning Validation Activities in medical device manufacturing.

RESPONSIBILITIES:

  • Evaluate cleaning validation, facilities/ utilities qualification and Test method validation records to ensure compliance with FDA regulations and current procedures.
  • Approve validation Quality Records
  • Apply extensive knowledge and expertise to identify gaps, documentation errors, deficiencies and deviations in validation records.
  • Escalate difficult, unresolved issues to the next management level.
  • Ensure that validation records are accurate, complete with the corresponding objective evidence to support the validation performed.
  • Review and approve of Validation deviations.
  • Able to make recommendations to solve quality issues found in validation records.

QUALIFICATIONS:

  • Minimum of B.S. Degree in Engineering or Science (Chemistry)
  • Minimum of 7 years of experience in Engineering or Quality related area OR minimum of 5 years of experience with a Master’s Degree or above in Engineering or Science - performing cleaning validation activities.
  • Minimum of 5 performing quality records review and approval process.


Posted: August 17, 2017, 8:39 am
Category : Quality Engineer - Medical Device
Job Type : Contract
Id : 7056
Region : Twin Cities

Seeking a Principal Quality Engineer for Cleaning Validation Activities associated with Medical Device Manufacturing.

 

JOB RESPONSIBILITIES:

  • Evaluate existing Cleaning Processes to determine which ones need to be validated.
  • Define cleaning validation strategies.
  • Design cleaning processes characterizations and create reports.
  • Prepare and execute cleaning validation protocols.
  • Create reports.
  • Update Cleaning Validation and Control/Monitoring processes procedures, templates and forms.
  • Update the training material related to the Cleaning Validation / control and monitoring processes.
  • Update content of cleaning validation master plan (CVMP).
  •  Report on progress against CVMP implementation including regular updates and established metrics.
  • Apply extensive knowledge and expertise to identify which analytical methodology should be used to detect residuals for the cleaning validation activities.
  • Define and execute recovery studies.
  • Participates in the development/validation activities of analytical test methods
  • Resolve issues and ensure task completion by establishing priorities and reaching agreement with team members and functional managers.
  • Escalate difficult, unresolved issues to the next management level.

 

REQUIRED QUALIFICATIONS:

  • Minimum of B.S. Degree in Engineering or Science (Chemistry)
  • Minimum of 7 years of experience in Engineering or Quality related area OR minimum of 5 years of experience with a Master's Degree or above in Engineering or Science - performing cleaning validation activities.
  • Minimum of 2 years of experience in Analytical Laboratories developing / validating Analytical Test Methods and performing cleaning validation activities.

 

PREFERRED QUALIFICATIONS:

  • Hands on experience with Cleaning Validation Activities.
  • Working knowledge of FDA regulations (21 CFR 820, and 11), ISO 13485, and Company quality requirements associated with validation.
  • Knowledge of Test Method Validation, specifically with Analytical test methods validation processes.
  • Experience in a manufacturing environment.
  • Project management skills (planning and estimating phases, work and task breakdown structures, set milestones, remove barriers to meet milestones).
  • Influence management skills; ability to work constructively across all functions of the organization and build relationships.
  • Strong technical writing and documentation review skills.
  • Strong critical thinking and analytical skills.


Posted: August 17, 2017, 8:30 am
Category : Quality/Regulatory
Job Type : Contract
Id : 7055
Region : Twin Cities

Seeking a Principal Quality Engineer to perform Test Method Validation Activities for medical device manufacturing.

JOB RESPONSIBILITIES:

  • Evaluate existing test method processes to determine the validation strategy.
  • Ensure that the test methods are documented.
  • Ensure that personnel are trained to perform the test methods.
  • Develop and validate new test methods when required.
  • Create protocol.
  • Facilitate the protocol execution.
  • Create reports.
  • Work with subject matter experts to fully understand the test methods and understand how those methods are used.
  • Resolve issues and ensure task completion by establishing priorities and reaching agreement with team members and functional managers.
  • Escalate difficult, unresolved issues to the next management level.

JOB QUALIFICATIONS:

  • Minimum of B.S. Degree in Engineering
  • Minimum of 7 years of experience in Engineering or Quality related area OR minimum of 5 years of experience with a Master's Degree or above in Engineering or Science - performing validation activities.
  • TMV Experience
  • At least 3 -5 years of experience creating and validating test methods.


Posted: August 17, 2017, 8:22 am
Category : Mechanical Engineer
Job Type : Permanent
Id : 7054
Region : Twin Cities

Seeking a Mechanical Engineer to perform the following duties:

  • Design custom automated machinery Using SolidWorks 3D CAD software.
  • Perform machine design calculations.
  • Specify commercial components.
  • Meet project deadlines in a cost-efficient manner.
  • Safely perform duties following quality standards.
  • Participate in team building, training and department communications.
  • Work as a team player with management and co-workers to develop a win-win partnership through positive relationships and excellent interpersonal skills.
  • Maintain a commitment to vision and “spirit” by partnering with new and current employees by demonstrating outstanding service and integrity.


Posted: August 16, 2017, 12:03 pm
Category : Mechanical Designer
Job Type : Contract
Id : 7053
Region : Twin Cities

Seeking a Mechanical Design Engineer to provide Finite Element Analysis (FEA) support for Medical Device product development. The emphasis will be on modeling mechanical systems to predict forces, deflections, stress, and strain in complex medical device assemblies subjected to in vivo and in vitro types of load conditions. Bearing in mind first principles, the Computational Modeling Engineer will understand customer requirements, formulate a modeling approach to address those requirements, independently carry out the modeling activities, and provide concise communication of the results through technical reports and presentations.

Minimum Qualifications:

  • B.S. engineering degree with 7+ years of experience in non-linear finite element analysis
  • Proficient with Simulia/Abaqus software including CAE, Standard and Explicit
  • Demonstrated problem solving and critical thinking skills
  • Demonstrated verbal and written communication skills

Desired Qualifications:

  • M.S. or PhD engineering degree
  • Experience with medical device design


Posted: August 16, 2017, 8:23 am
Category : Packaging Engineer
Job Type : Contract
Id : 7051
Region : Twin Cities

Looking for a Packaging Engineer to be responsible for assisting in design, development, and support of package systems and processes for sterile and non-sterile medical devices including components, assemblies, and end items. This candidate will be responsible for demonstrating high-level performance that delivers high-quality packaging on schedule, which meets customer, patient, and regulatory needs.

Basic Qualifications:

Bachelor’s Degree in Packaging and minimum 1 year of experience in packaging (medical device preferred)



Posted: August 15, 2017, 8:47 am
Category : Quality Engineering
Job Type : Contract
Id : 7050
Region : Twin Cities

In this position, the Human Factors Engineer will apply knowledge of human performance (perceptual, cognitive and motor skills) and human factors techniques to identify user needs, requirements, and inform design across the product lifecycle. Activities will include: field research to identify user needs and work flows; task analysis; software and hardware user interface design evaluations; usability testing; risk assessment; and post-launch outcomes analysis.

POSITION RESPONSIBILITIES:

  • Conduct field studies/research and apply the outcomes to requirements definition, concept development, and detailed design.
  • Work closely with marketing, product planning, engineering, manufacturing, and regulatory to produce design solutions that meet user needs and take into account business needs and manufacturing constraints.
  • Prepare sketches and rendered design illustrations for presentation of design concepts. Direct the development of physical mock-ups and interactive prototypes of design concepts.
  • Plan and conduct end user evaluations of product concepts, analyze data, document evaluation methods and results; and present design recommendations to the product team.
  • Maintain knowledge of regulatory and industry requirements for Human Factors in medical device development and perform Human Factors activities within the constraints of a regulated environment.
  • Ensure personal understanding of all quality policy/system items that are applicable.
  • Follow all work/quality procedures to ensure quality system compliance and high quality work.
  • Travel globally up to 20% of the time.


Posted: August 14, 2017, 6:24 am
Category : Quality Engineer - Medical Device
Job Type : Contract
Id : 7048
Region : Twin Cities

Seeking a Principal Quality Engineer to perform Test Method Validation Activities for medical device manufacturing.

JOB RESPONSIBILITIES:

  • Evaluate existing test method processes to determine the validation strategy.
  • Ensure that the test methods are documented.
  • Ensure that personnel are trained to perform the test methods.
  • Develop and validate new test methods when required.
  • Create protocol.
  • Facilitate the protocol execution.
  • Create reports.
  • Work with subject matter experts to fully understand the test methods and understand how those methods are used.
  • Resolve issues and ensure task completion by establishing priorities and reaching agreement with team members and functional managers.
  • Escalate difficult, unresolved issues to the next management level.

JOB QUALIFICATIONS:

  • Minimum of B.S. Degree in Engineering
  • Minimum of 7 years of experience in Engineering or Quality related area OR minimum of 5 years of experience with a Master's Degree or above in Engineering or Science - performing validation activities.
  • TMV Experience
  • At least 3 -5 years of experience creating and validating test methods.


Posted: August 11, 2017, 7:43 am
Category : Electrical Designer
Job Type : Permanent
Id : 7046
Region : Twin Cities

Seeking a Control Systems Designer for both design and technician responsibilities.

Accountabilities:

  • Design electrical, controls, and facility integration systems
  • Coordinate C & I Design with lead engineer
  • Drafting
  • Specify and select hardware
  • Support systems fabrication, checkout installation and acceptance testing
  • Support customer service
  • Provide labor and material cost estimates
  • Work as part of a team
  • Perform remote site field installation, checkout, testing, and customer service including interfacing with customer
  • Travel approximately 15% of time both domestically and internationally

Skills:

  • PC skills
  • Electrical design
  • Hands on electrical assembly and installation
  • AutoCAD
  • SolidWorks Electrical

Experience:

  • Work experience with control and instrumentation equipment or design is preferred

Education:

  • Associate degree in electrical technology or equivalent
  • Due to the nature of our work US citizenship or permanent resident status is required.


Posted: August 10, 2017, 1:36 pm
Category : Electrical Engineer
Job Type : Permanent
Id : 7045
Region : Twin Cities

This is an excellent opportunity for a Controls Engineer to develop and manage industrial control systems. The Controls Engineer is responsible for designing, implementing, commissioning, and supporting controls, software, and data acquisition systems.  This role requires autonomy and individual drive to successfully execute project deliverables, yet also requires collaboration with other engineers, projects managers, and customers.   This role is a blend of hardware and software capabilities and requires a systems level perspective in order to properly integrate a complete and high quality solution.

 

Requirements:

  • Deliver concept designs, system drawings, parts lists, functional specifications, software, and reports for the control and data acquisition of wind tunnels, facility control, and engine test systems.
  • Deliver quality engineering service on schedule and within budget.
  • Demonstrate effective individual task management while working within an interdisciplinary team environment.
  • Interface with various transducers, instrumentation, and peripherals through a variety of interfaces and protocols.  Examples of this include load cells, servo valves, thermocouples, limit switches, MIL-STD connectors.
  • Provide input and guidance concerning potential use and benefit of emerging technologies.
  • Gather technical specifications and designs from key stakeholders and customers to determine and create test system controls and software/hardware specifications.
  • Travel to customer sites for design reviews, site surveys, and system commissioning. Travel is both domestic and international.
  • Oversee the implementation and release of system drawings by working with CAD designers to produce specification and design drawings.
  • Identify critical problem areas, project risks, alternative solutions and potential consequences.Communicate these issues to project stakeholders and management.
  • Support or perform system assembly, checkout, and site installation.
  • Develop high quality documentation such as operations manuals, test procedures, design specifications, and validation plans.
  • Ensure compliance with design criteria and customer, government, and company engineering standards.
  • Support, modify and upgrade existing hardware and software per customer requests.

 

Qualifications/Education:

  • Bachelor's degree in Engineering.
  • 2 to 5 years of relevant experience implementing automation systems.
  • Working knowledge of electronics and electrical systems used in systems test, automation and control applications.
  • Working knowledge of instrumentation schematics and system wiring diagrams and control panels.
  • Working knowledge of electro-mechanical and electro-hydraulic systems.
  • Excellent problem solving and troubleshooting capabilities.
  • Excellent written and oral communication skills, demonstrated initiative, and attention to completeness, accuracy, and detail.
  • Ability to work alone effectively and interface productively with customers, project managers, engineers, and other staff.
  • Demonstrated ability to meet budgets and schedules.


Posted: August 10, 2017, 1:32 pm
Category : Manufacturing Engineer
Job Type : Contract
Id : 7044
Region : Twin Cities

Seeking a Manufacturing Engineer to develop and implement production and processing methods and controls to meet quality standards in most cost efficient manner. The Engineer will investigate and resolve work-in-process problems. Also, recommend and implement improvements and/or modifications in sequence of operations, equipment utilization and related matters. Monitors assigned operations to assure compliance with approved methods and standards.

Required Experience:

  • DOE
  • ANOVA
  • Process FMEA.
  • Master Validation Plan
  • Process Characterization
  • IQ
  • OQ
  • PQ
  • Bachelor of Science in a related engineering field
  • Minimum of 5 years relevant industry experience


Posted: August 10, 2017, 11:36 am
Category : Quality Engineer - Medical Device
Job Type : Contract
Id : 7043
Region : Twin Cities

Seeking a Supplier Quality Engineer assure materials used in Company products are of high quality and reliability. This person will actively work with suppliers to resolve quality issues identified at Receiving Inspection or in Manufacturing. 

POSITION RESPONSIBILITIES: 

  • Review and resolve material issues through coordination of efforts across Company operations and at incoming inspection. 
  • Interface with Company incoming inspection employees, including development and review of inspection procedures. 
  • Support product continuation by assuring the quality of the components used in the manufacturing floor, and working supplier/component quality related issues to resolution. 
  • Perform test method validation on Receiving Inspection test methods. 
  • Review and approve changes to components for quality impact to materials and processes. 
  • Participate in or lead materials problem solving, failure analysis, and process changes. 
  • Participate in daily production meetings to address component availability issues. 

 

BASIC QUALIFICATIONS: 

  • Bachelor's Degree 
  • 2+ years of experience in quality, manufacturing or other engineering field 

 

PREFERRED QUALIFICATIONS: 

  • Understanding of quality principles, procedures, methodologies, and basic statistics. 
  • Knowledge of regulatory environments (i.e.: ISO, FDA-GMP, etc.) 
  • Knowledge of statistical analysis techniques 
  • Knowledge of DMAIC problem solving methodology


Posted: August 9, 2017, 12:34 pm
Category : Firmware Engineer
Job Type : Contract
Id : 7042
Region : Twin Cities

Looking for an R&D engineer for design and development of medical software and

Instrumentation. Embedded software development is the key responsibility along with test, troubleshooting, and documentation.

 

Qualifications:

  • Experience in a medical product development environment.
  • Software design experience with C and C++ in an embedded environment.
  • Software design experience with embedded RTOS (MQX preferred, QNS, SafeRTOS)
  • Software design experience with networking technologies (SSH, FTP, OpenSSL)
  • Software design experience with security (SHA2, CRC, salted hashing
  • Experience with IEC62304 is highly desirable

Responsibilities:

  • Write embedded software in a microprocessor-based embedded environment.
  • Design and documentation of embedded software for medical products.

Education:

  • Bachelor of Science in Electrical Engineering or Computer Science.


Posted: August 9, 2017, 12:14 pm
Category : Systems Engineer
Job Type : Contract
Id : 7041
Region : Twin Cities

Seeking a Systems Engineer for Medical Device Manufacturing . Typical product designs involve complex electronic circuits, wireless communication, batteries and a mix of consumer and medical technologies.

Position Responsibilities:

  • Defines requirements for non-implantable medical device products and features that meet the expectations and uses of the customer, regulatory agencies, and the business.
  • Provides technical leadership in the definition, evaluation, and problem analysis of system designs across functional groups. This includes investigating and resolving system issues, making improvements to address customer feedback and requests, and leading testing activities.
  • Documents tradeoffs, rationale, and potential solutions.
  • Translates customer needs into specific, well-written requirements.
  • Lead/participate in technical architecture activities for system definition, including partitioning, establishing performance measures, and well defined interfaces.
  • Performs Risk Analysis, such as FMEA, and Hazard Analysis activities for systems, features, and implementations with the intent to eliminate or mitigate the risks in the identified scenarios.
  • Defines and performs system validation activities ensuring the behavior of the system meets user needs and intended use.
  • Identifies and solves product issues both internally during product development and post launch field issues.
  • Provides field support to customers and clients for Company systems.
  • Conducts training for customers and clients.
  • Reviews technical literature and manuals.
  • Ensure personal understanding of all quality policy/system items that are applicable. Follow all work/quality procedures to ensure quality system compliance and high quality work.

Basic Qualifications:

  • Bachelors of Science in System Engineering, Electrical Engineering, Computer Science or related field.
  • 6+ years of job-related experience with Bachelor’s Degree OR
  • 4+ years of job-related experience with a Master’s Degree

Preferred Qualifications:

  • Engineering MS degree preferred.
  • 2+ years of working with non-implantable medical systems
  • Experience in engineering biomedical systems.
  • Experience in troubleshooting firmware.
  • Experience working with ISO and Quality System Regulation requirements.
  • Experience in System Engineering discipline or use of system engineering methodologies.
  • Demonstrated strong verbal/written communication.
  • Experience working in cross-functional and team environments.
  • Experience working in a FDA regulated and/or medical device environment.


Posted: August 8, 2017, 8:44 am
Category : Packaging Engineer
Job Type : Contract
Id : 7040
Region : Twin Cities

Seeking a Packaging Engineer to design, develop, and verify packaging and package labeling for the Medical Device Manufacturing. This position includes coordinating functionally-related project activities and working with cross-functional teams.

POSITION RESPONSIBILITIES:

  • Conceptualize, specify, design, simulate, and verify portions of packaging design for medical devices or instrumentation in a regulated environment using standard package engineering tools and methods.
  • Prepare, document, and maintain formal documentation, including protocols and reports. Documentation will meet FDA/ISO guidelines and Company procedures for design control evidence.
  • Under general direction, determine and develop approach to solutions. Prepare deliverable and timeline estimates for own project work.
  • Participate in technical reviews; lead the review for their own work.
  • Access packaging aspects of method, process, or material performance against established standards or specifications. Identify and investigate negative trends or failing conditions leading to root cause.
  • Work with cross-functions to identify design inputs and design decisions for package label development. Including, but not limited to, geographical, manufacturing, and distribution inputs.
  • Create and format content for package labels and prepare for technical review and alignment.
  • Partner with manufacturing and distribution sites to identify and verify requirements for production of package labels.

BASIC QUALIFICATIONS:

  • BA/BS in packaging, mechanical, or related engineering
  • 2+ years of job-related experience

PREFERRED QUALIFICATIONS:

  • Experience working in a regulated environment.
  • Experience working in a medical device environment.
  • Experience working with FDA, ISO, EN, and/or GMP standards.
  • Proven, strong detail-oriented work skills.
  • Understanding and wide application of technical packaging principle, theories, and concepts in the field.
  • Efficient in computer skills, project management, and working knowledge of other related disciplines.
  • Strong communication and organizational skills.
  • Self-starter with ability to work effectively across the organization.


Posted: August 8, 2017, 6:47 am
Category : Software Engineer
Job Type : Contract
Id : 7039
Region : Twin Cities

Seeking a Software Engineer to be responsible for providing key technical expertise and quality leadership of Cardiac Rhythm Heart Failure (CRHF) non-implantable medical software systems, helping to ensure they exceed the requirements and expectations of patients, clinicians, regulators and the business. Position spans the full range of the product life cycle from development and market release to sustaining our software products following market launch.

Primary focus will be on leading and facilitating the Quality and Reliability activities while collaborating with the product design and development teams.

 

Responsibilities:

  • Primary responsibility is for the quality of our products which support the monitoring and follow up of patients with implanted cardiac devices.
  • Understanding the importance of product performance, functions, and product use environments to appropriately and strategically apply technical knowledge, reliability tools and reliability methodologies to drive reliability improvements
  • Define the approach and methods to prove and demonstrate reliability from the beginning, including the identification and proper collection of performance objectives, design requirements, measures and metrics
  • Proactively design in reliability and perform analysis against features, requirements, architecture, interfaces, and designs, through the appropriate application of reliability engineering techniques
  • Work collaboratively with Design Engineering, Development, Test Engineering, Regulatory Affairs, and other cross-functional partners
  • Required Qualifications:
  • BS in Software Engineering, Computer Science, Reliability Engineering, Systems Engineering, Electrical Engineering or equivalent field
  • 7 years' relevant experience with a Bachelor's or 5 years' relevant experience with a Master's degree
  • Excellent critical thinking and problem solving skills, including application of structured problem solving methods and tools
  • Strong written and oral communication skills, including the ability to clearly and concisely summarize complex technical concepts and problems
  • Strong collaboration and influence skills
  • Fluent in English (both oral and written)

Preferred Qualifications:

  • Advanced degree in engineering, science, or equivalent field
  • Certified Reliability Engineer (CRE), Certified Software Quality Engineers (CSQE) or equivalent certification
  • Experience in software fault tolerant design, fault prevention techniques, design for testability methods, software FMEA and FTA
  • Experience with Software Reliability Engineering models including growth models
  • Experience in the design, maintenance, or continuation engineering of released software or software systems, including mobile applications
  • Experience with automated and/or manual software tests
  • Experience with Agile or behavior-based development
  • Experience with C, C++, C#, Java, Perl, Python
  • Experience working with Unix/Linux, system libraries, file systems, client-server protocols
  • Experience with network theory (TCP/IP, UDP, ICMP), MAC Addresses, IP packets, DNS, OSI layers, load balancing
  • Experience in medical devices or other regulated industry
  • Experience working with IEC 62304
  • Knowledge of Design for Six Sigma (DFSS), Design for Lean Sigma (DFLS), Design for Reliability and Manufacturability (DRM), or other robust design practices


Posted: August 4, 2017, 11:58 am
Category : Electrical Engineer
Job Type : Contract
Id : 7038
Region : Twin Cities

Seeking an Electrical Engineer to design, deliver, and support equipment solutions for a wide range of innovative medical electronics-based products and production test equipment. To be responsible for the development and release of equipment solutions supporting functional/parametric test measurements and/or process control. Will also be involved in determining if existing equipment is adequate to support production manufacturing requirements for new products or design a custom solution.

 

Will develop and deploy test or process control solutions using Automated Equipment. Responsible for implementing and qualifying both the software and the hardware portion of the equipment solution. Hardware design is accomplished using schematic tools and interfacing with manufacturing and process development engineers to create an optimized solution for production equipment release and support.

 

Additional aspects of the equipment solution development include: software is developed and the software/hardware is debugged while interfacing to the equipment; perform R&R (repeatability & reproducibility) analyses; qualify, document and support test application releases. Utilizes software languages and environments including LabVIEW, and/or CAD in the documentation and validation of code and electrical design. Troubleshoots software and hardware problems using root cause analysis and provides technical solutions for equipment-related problems and provides yield improvement solutions.

 

Responisbilities:

  • Qualifying, developing and debugging dedicated hardware and software, performing verification and validation activities, performing Measurement Systems Analysis (Gage R&R studies); all in support of test solution release for production testing of electronic components
  • Deployment and qualification and of equipment. Ensures appropriate documentation is maintained and completed for all technology programs transferred to product line specific areas
  • Design and qualify new custom tooling/equipment (IQ/OQ/PQ, Support)
  • Troubleshooting yield and performance issues to root cause using statistics-based analyses and providing related technical solutions
  • Following software application development procedures and demonstrate compliance through technical documentation generation
  • Troubleshooting electrical schematics and understanding PCB layout requirements
  • Active and key participant in the evaluation and strategic planning for new: technology, products and materials and their impact on the business. Performs research and evaluates new ideas & technologies
  • Develops electromechanical technical solutions to complex problems that require the regular use of ingenuity and creativity
  • Work is performed with minimal direction
  • All activities must be performed in compliance with the Quality System.
  • Performs duties in compliance with environmental, health and safety related site rules, policies or governmental regulations
  • Travel requirement: less than 10%

Education:

  • Bachelors in Electrical Engineering, Controls Engineering, Biomedical Engineering or related Engineering discipline.
  • 2-4 years of experience in Electrical Engineering Design and Development with Bachelors
  • 0-2 years of experience in Electrical Engineering Design and Development with an Advanced degree
  • Specialized Knowledge Required:
  • Familiar with LabVIEW or PCB and schematic layout tools
  • 1+ years of experience working in a medical or other regulated industry
  • Strong communication, manufacturing process and product industrialization skills
  • Solid troubleshooting skills


Posted: August 4, 2017, 11:42 am
Category : Quality Engineering
Job Type : Permanent
Id : 7037
Region : Twin Cities

Seeking a Quality Engineer to provide leadership and work with other functions in helping the plant meet objectives in safety, delivery, quality, efficiency, and customer satisfaction.

 

Responsibilities:

  • Responsible for the investigation and resolution of customer complaints regarding quality.
  • Focus on improving internal FPY. Analyze data and drive corrective actions upstream in the value stream. Formally document lessons learned to make systemic improvements.
  • Responsible for maintaining and improving quality levels for current and onboarding customers.
  • Create, manage and deploy the required documentation and records to support a stable QMS.
  • Facilitate and promote use of appropriate problem solving techniques for effective root cause analysis (RCA) and successful corrective action (CA).
  • Work with Project Managers by preparing PPAP Documentation (FMEAs, PSWs, Control Plans, etc.), develop New Product QC sheets, Work Instructions, Job Aids, etc. (quality related activities that need to be completed prior to launching products for new customers).
  • Project Work – Lead key process improvement projects working with suppliers and customers.
  • Work with suppliers to insure Quality products and good relationships involving product procurement.
  • Work with Sales Managers by representing DRC in initial supplier audits by potential customers.
  • Lead internal and external Corrective Action/Preventative (CAPA) activities and perform verification of documented Corrective Actions (CA).
  • Collect and analyze quality data to determine training opportunities.  Administer "Read & Understand" documents, Quality Alerts, present the quality portion of the New Employee Orientation Program, provide specific training, and maintain the Training Matrix.
  • Use Lean tools to reduce waste and prevent defects.
  • Work with Production and Quality to maintain ISO 9001 certification and obtain ISO 14001 certification.
  • Keep Director of Quality apprised of all issues involving Quality.
  • No direct supervision but may provide work direction to other quality and manufacturing employees.

Education, experience, and skills:

  • Bachelor's degree in Quality/Engineering/ Technology/Science/Math or equivalent experience.
  • Minimum of 5+ years of experience in a manufacturing environment.
  • Experience in preparing PPAP documentation
  • Strong leadership skills and experience leading cross functional teams
  • Auditing experience and knowledge of ISO 9001 (14001 helpful)
  • Ability to analyze data utilizing standard methods
  • Proven ability to apply and deploy Lean principles and tools to support program and/or process performance improvements
  • Demonstrated ability to exercise sound judgment and employ appropriate decision making skills with minimal to no supervisory intervention
  • Excellent interpersonal and communication skills with the ability to communicate throughout all levels of the company and customer community; strong negotiation and influencing skills 
  • Demonstrated proficiency at preparing and presenting upper management and customer presentations
  • Excellent skills using Microsoft tools (Excel, Word, PowerPoint)
  • Periodic travel may be required.


Posted: August 4, 2017, 10:52 am
Category : Electrical Engineer
Job Type : Contract
Id : 7036
Region : Twin Cities

We are currently seeking a Principal Electrical Engineer who is an expert in circuit analysis and verification with a strong working knowledge of electrical bench evaluation methods and data analysis skills.

 

REQUIRED:

  • Bachelor's Degree in Electrical Engineering
  • 5+ year's industry experience

DESIRED SKILLS:

  • Experience performing data analysis using tools such as Microsoft excel, Spotfire, SQL for database queries, MATLAB to assess compliance to requirements and statistical significance.
  • Proficient in using typical lab equipment (e.g. oscilloscopes, signal generators, spectrum analyzers, voltmeters, etc.)
  • Demonstrated ability to troubleshoot, simulate and resolve issues in electronic devices consisting of an embedded system with custom analog peripherals.
  • Experience in use and design of computer controlled test benches using bus controlled equipment (i.e. GPIB) and equipment control language like LabVIEW
  • Experience in leading and participating in technical review of performance of an electronic device
  • Experience in operating in a regulated industry
  • Experience in managing, scheduling, tracking work of a small team of electrical technicians
  • Good written and verbal communication skills
  • Experience in the medical device industry
  • Experience working under standards FDA 21CFR Part 820, ISO 13485, ISO 9001


Posted: August 3, 2017, 1:32 pm
Category : Mechanical Designer
Job Type : Permanent
Id : 7034
Region : Minnesota

Seeking a Mechanical Design Engineer to apply engineering techniques in designing new hydraulic cartridge valves and manifolds and make improvements to current products. This position will work as part of a team, and collaborate with sales and marketing, quality, and manufacturing to develop robust products which support future growth plans. This role includes working directly with customers developing innovative solutions to complex problems pertaining to products and unique applications.

 

DUTIES AND RESPONSIBILITIES

  • Lead new product development projects requiring unique solutions while maintaining detailed project schedules, meeting milestone deliverables and cost and product performance goals. Interface closely with cross-functional team members.
  • Support adjacent teams as needed. Such as customer interface for technical queries, application guidelines, development of custom design solution etc.
  • Coordinating and support product prototype builds. Writing and implementation of verification test plans.
  • Work with manufacturing engineering and operational excellence teams on meeting new product manufacturability and cost goals, as well as existing product cost down opportunities.
  • Work with applications and manufacturing to investigate and resolve technical issues associated with design and manufacturing of our hydraulic products.
  • Produce and maintain design 3D models, drawings and Specification sheets in our system, including full design history.
  • Participate in cross-functional teams to address and resolve manufacturing, design and quality problems, and ensure the continuous, on-going improvement of processes and methods.
  • Comply with all quality and safety regulations.
  • Provide strong communication and support to team.
  • Must contribute to culture of continuous improvement.

 

REQUIRED QUALIFICATIONS

  • A Bachelor's degree in Mechanical and/or Design Engineering.
  • Minimum of four (4) years of engineering experience.
  • Experience in 3D software design packages.
  • Experience in stack-up analysis, creating detailed drawings and experience in geometric dimensioning and tolerances.
  • Hands on approach with a strong mechanical ability.
  • Team Player - Ability to get along well with a variety of personalities.
  • Problem Solving/Innovative - Ability to find creative solutions for complex problems.
  • Strong interpersonal communications skills. Ability to proficiently speak, read, and write in English.
  • Strong computer skills and proficiency in Microsoft Office products including Word, Excel, and Outlook.
  • Employee must have ability to lift up to 50 pounds.

 

DESIRED QUALIFICATIONS

  • Seven (7)+ years of Design experience.
  • Knowledge of various machining and manufacturing processes.
  • Hydraulic experience.
  • Understanding of fluid power.
  • Knowledge of machine shop practices.
  • Desire for design.
  • Experience working within quality management systems.
  • Experience in testing techniques.
  • Self-starter with desire to be successful.
  • Familiar with and understanding of assembly and metal fabrication processes, gages and fixtures.
  • Strong communication skills, ability to speak with all levels of organization.
  • Familiar with Design for Six Sigma (DFSS) and Failure Modes and Effects Analysis (FMEA).


Posted: August 2, 2017, 1:46 pm
Category : Quality/Regulatory
Job Type : Contract
Id : 7033
Region : Twin Cities

Seeking a Principal Quality Engineer for Cleaning Validation Activities associated with Medical Device Manufacturing.

 

JOB RESPONSIBILITIES:

  • Evaluate existing Cleaning Processes to determine which ones need to be validated.
  • Define cleaning validation strategies.
  • Design cleaning processes characterizations and create reports.
  • Prepare and execute cleaning validation protocols.
  • Create reports.
  • Update Cleaning Validation and Control/Monitoring processes procedures, templates and forms.
  • Update the training material related to the Cleaning Validation / control and monitoring processes.
  • Update content of cleaning validation master plan (CVMP).
  • Report on progress against CVMP implementation including regular updates and established metrics.
  • Apply extensive knowledge and expertise to identify which analytical methodology should be used to detect residuals for the cleaning validation activities.
  • Define and execute recovery studies.
  • Participates in the development/validation activities of analytical test methods
  • Resolve issues and ensure task completion by establishing priorities and reaching agreement with team members and functional managers.
  • Escalate difficult, unresolved issues to the next management level.

REQUIRED QUALIFICATIONS:

  • Minimum of B.S. Degree in Engineering or Science (Chemistry)
  • Minimum of 7 years of experience in Engineering or Quality related area OR minimum of 5 years of experience with a Master's Degree or above in Engineering or Science - performing cleaning validation activities.
  • Minimum of 2 years of experience in Analytical Laboratories developing / validating Analytical Test Methods and performing cleaning validation activities.

PREFERRED QUALIFICATIONS:

  • Hands on experience with Cleaning Validation Activities.
  • Working knowledge of FDA regulations (21 CFR 820, and 11), ISO 13485, and Company quality requirements associated with validation.
  • Knowledge of Test Method Validation, specifically with Analytical test methods validation processes.
  • Experience in a manufacturing environment.
  • Project management skills (planning and estimating phases, work and task breakdown structures, set milestones, remove barriers to meet milestones).
  • Influence management skills; ability to work constructively across all functions of the organization and build relationships.
  • Strong technical writing and documentation review skills.
  • Strong critical thinking and analytical skills.


Posted: August 2, 2017, 9:12 am
Category : Mechanical Engineer
Job Type : Permanent
Id : 7031
Region : Twin Cities

Looking for a Product Development Engineer to work with the Design Engineering team as an innovator and problem solver throughout the design process of fiber optic products and assembly processes. Use knowledge of mechanical engineering and industry standards to act as an internal consultant to the entire team.

 

POSITION DESCRIPTION:

 

Assist in the design of parts/components for high-volume production, ease of assembly, and cost as well as custom low volume application specific solutions.

  • Identify problems or risks, collect and analyze data and develop solution support from the concept stage of a new product through production manufacturing.
  • Suggest alternatives in design or process to internal and external parties, during design reviews, and elsewhere as applicable.
  • Work proactively with other members of the engineering staff where possible, providing input and assistance on design, manufacturing, quality, process and test issues.
  • Review SARs as directed, providing Sales/PM and Designers with innovative suggestions to meeting customer needs

Develop manufacturing processes for new products and document appropriately

  • Define and develop testing procedures and methods for qualification of new product developed both internally and with external partners.
  • Assist Mfg. Engineering in the design and development of internal and external procedures for manufacturing, assembly, testing, and packaging.
  • Specify equipment as necessary for product assembly and development
  • Manage the schedule for new mechanical components, cost, and design details to ensure on time delivery and successful completion of all project milestones.

Remain abreast of current industry, supplier, and technology advancements and standards to ensure company's products remain marketable and competitive.

 

POSITION REQUIREMENTS

  • Bachelor's degree, Mechanical Engineering
  • 2+ years' experience in new product development
  • Excellent organizational, decision making, and communication skills
  • Strong problem-solving skills
  • Background in termination and management of fiber optic cabling a plus
  • Understands industry approved manufacturing methods and standards
  • EIT Certificate helpful
  • Knowledge of solid modeling in Creo/Pro E helpful


Posted: August 1, 2017, 1:16 pm
Category : Software Engineer
Job Type : Contract
Id : 7028
Region : Twin Cities

 

The Senior Software Engineer is responsible for creating, maintaining and expanding software systems over multiple platforms which are used internally and externally. This position offers the opportunity to leverage your existing skills to lead technical tasks and projects as well as continuing to gain new skills. This is considered an advanced developer position and requires a Bachelor's Degree in Computer Science or a related field.

 

POSITION RESPONSIBILITIES:

  • Designing and developing solutions for a variety of technical problems
  • Work closely with other software developers on increasingly complex technical initiatives
  • Focus on relational database and NoSQL design for scalable applications & services
  • Work with software teams of all skill levels to design, develop and test software applications and systems
  • Utilize cloud services and infrastructure for new development initiatives
  • Assist with writing technical and support documentation
  • Take part in code and technical review processes
  • Contribute to task identification, work effort estimates, and work schedules for development and maintenance activities

 

REQUIRED EXPERIENCE:

  • Bachelor's Degree in Computer Science of related discipline required
  • 6+ years C#, JAVA or similar programming / development experience
  • 6+ years experience with relational databases such as MySQL and SQL Server
  • 6+ years experience with web technologies
  • 2+ years experience with node.js or other JavaScript frameworks
  • 2+ years experience with MongoDB or other non-relational databases

 

PREFERRED QUALIFICATIONS:

  • Experience with continuous integration and automated deployments
  • Experience with container solutions such as Docker
  • Excellent knowledge of OO design principles
  • Experience with REST and Microservices architectures
  • Experience with cloud hosting environments such as AWS or Azure
  • Experience with Scrum or Agile methodologies
  • Ability to manage your own projects and tasks from design to implementation
  • Experience creating and maintaining unit tests
  • Excellent verbal and written communication skills
  • Excellent problem solving and critical thinking skills
  • Self-motivated, self-directed individual who takes pride in their work product


Posted: July 31, 2017, 10:45 am
Category : Quality Manager
Job Type : Permanent
Id : 7026
Region : Twin Cities

Seeking a Quality Manager for the quality related duties associated with the development and production of company products.  This includes: Product planning, inspection, calibration, and ISO quality management.

 

JOB RESPONSIBILITIES:

ISO 9001-

  • Manage the ISO 9001 quality management system and develop policies and procedures. This will include the transition from ISO 9001:2008 to ISO 9001:2015 within the next year
  • Responsible for coordinating and participating in ISO 9001 internal audits
  • Act as Company Systems Management representative and facilitate customer and registrar audits
  • Conduct investigations, root cause analysis and provide corrective and preventative actions based on sound engineering analysis and review.  Provide effective solutions that will drive continuous and measurable improvements.
  • Responsible managing and maintaining the document control system
  • Participate in quality improvement teams, leading or assisting as required
  • Assist procurement in monitoring and managing suppliers and supplier quality
  • Quality Related Customer Service Administration-
  • Respond to customer concerns regarding quality issues
  • Manage the return material process and including the analysis of returned products

Product Planning-

  • Review, verify and manage the implementation of customer requirements through the Advance Product Quality Planning process
  • Create quality plans for new or modified product programs
  • Create company quality standards
  • Work as team member to participate in risk analysis and mitigation
  • Responsible for generating and verifying customer required quality documentation and test reports

Inspection-

  • Manage the inspection department and create inspection policies and procedures
  • Ensure inspection needs are fulfilled, providing training and assistance as needed
  • Train inspectors on measurement application and techniques
  • Manage the nonconforming material and material review board process

Calibration-

  • Manage the calibration system for all company instruments
  • Maintain Quality department tooling and equipment
  • Determine measuring tool needs

REQUIRED EXPERIENCE:

  • Bachelor's degree (Engineering/Quality) or AAS degree in related field plus relevant experience
  • 2+ years' experience in quality
  • Background in quality systems applications with a strong understanding of the ISO 9001 standard
  • Background in planning and integration of quality process and objective into production process
  • Experience in machining and assembly manufacturing environments
  • Experience with CMM (Ziess) and Vision Measurement Systems
  • Background with ITAR compliance
  • Experience with ERP systems (IQMS, JobBOSS, Epicor, SAP, etc.)

ABILITIES:

  • Proven ability to prioritize and multitask
  • Strong problem solving ability and experience
  • Understanding and interpret drawings and GD&T
  • Understanding of regulatory requirements (RoHS, REACH, DFAR, ATEX, ITAR, UL, CE, etc.)
  • Communicate effectively and professionally
  • Work professionally with suppliers, customers, and coworkers


Posted: July 28, 2017, 9:45 am
Category : Electrical Designer
Job Type : Permanent
Id : 7025
Region : Twin Cities

Seeking an Electrical Design Engineer for the design, modeling, research, and refinement of Slip Ring products.  This also includes planning and documentation of testing and quality standards.

 

JOB RESPONSIBILITIES

Design:

  • Drive refinement of electrical slip ring product line.
  • Research and design expanded slip ring product offerings (4k video, Ethernet, fiber optic)
  • Execute models, images and work instructions proficiently using Autodesk Inventor and AutoCAD.
  • Create and maintain detail, layout, assembly, and shop drawings for new and existing products
  • Process Engineering Change Orders (ECO's)

Product Planning:

  • Review, verify and manage the implementation of customer requirements through the Advance Product Quality Planning process.
  • Work as team member to approve product designs and documentation.
  • Establish and verify testing and quality requirements.
  • Help create company quality standards.
  • Work as team member to participate in risk analysis and mitigation.

 

JOB REQUIREMENTS

  • B.S. in Electrical or Electronic Engineering with 2+ years related experience.
  • Understanding in ISO quality standards.
  • Familiarity with interpretation/creation of wiring schematics
  • Experience with electronic test equipment such as oscilloscopes, signal generators, signal analyzers, etc.
  • Understanding of GD & T.
  • Experience with Autodesk Inventor and AutoCAD.
  • Experience with ERP manufacturing software (IQMS preferred).
  • Experience with the design and manufacturing of electrical slip rings and/or other electronic components.

 

REQUIRED SKILLS

  • Plan and organize own workload, able to multitask.
  • Solve problems with minimal direction.
  • Communicate effectively within the organization, in addition to customers and suppliers.
  • Work cooperatively with other employees.


Posted: July 28, 2017, 9:33 am
Category : Packaging Engineer
Job Type : Contract
Id : 7024
Region : Twin Cities

 

Seeking a Packaging Engineer to perform a wide variety of complex duties, under general supervision, in a multi-functional environment of labeling, design, development and testing of packaging for medical devices. Execute the completion of milestones associated with the Package Engineering and the Product Development Procedure on specific projects. Participate on project development and operations teams to support the release of new products from concept through to Production. Additionally, the Package Engineer will implement process improvements, and support package system changes.  Contribute to cross functional teams to help drive successful results on process and cost improvement opportunities. Work with contract manufacturers and internal manufacturing facilities to develop packaging components and design documentation.

 

POSITION RESPONSIBILITIES:

  • Development of package labels, packaging components and assemblies for medical devices. Supports verification, validation, and implementation of package systems into manufacturing.
  • Continuation activities required to support product labeling, testing and overall compliance requirements.
  • Familiarization with working in a regulated environment.
  • Documentation activities associated with the qualification and release of package designs and specifications.
  • Coordination and communication of packaging technology and designs with project teams as part of the phase review development process.
  • Documentation activities associated with Bill of Materials/final package configurations.

 

BASIC QUALIFICATIONS:

  • Must have demonstrated skills in the use of computers and have experience with Word, Excel, Project, PowerPoint. 
  • Bachelor's Degree in Package Engineering
  • 1+ years industry experience

 

PREFERRED QUALIFICATIONS:

  • Excellent communication and presentation skills Project management skills Outgoing and Leadership based personality
  • Labeling System and Medical Device experience preferred


Posted: July 27, 2017, 6:22 am
Category : Electrical Engineer
Job Type : Contract
Id : 7023
Region : Twin Cities

Looking for a Senior Electrical Engineer to provide assistance to the Released Product Engineering group. This group participates in several cross functional teams for market released external medical instrumentation products. Cross functional project teams include members from Product Development, Manufacturing, Marketing, Sourcing, Contract Manufacturing Engineering, Quality, Reliability, and Regulatory functions. The group's primary objective is to provide the design expertise necessary to support continuity of quality and compliant products.

 

Position Responsibilities:

  • Create high quality formal documentation and records.
  • Create and implement Engineering Change Requests (ECR) and Engineering Change Orders (ECO) in Company's Product Data Management system. This includes leading the cross functional change review and approval process.
  • Create test plans and reports, and coordinate product testing.
  • Assess supplier driven changes and Part Change Notifications (PCN) for potential impact against product functional requirements, and document the rationale and/or testing necessary for approval of such notifications.
  • Communicate technical details and achieve the necessary understanding and trust from non-technical audiences.
  • Design, analyze, and test analog and digital circuits either independently or while working closely with a design technician.
  • Evaluate returned product to determine the root cause of field returns and establish design improvements.
  • Drive suppliers to provide timely resolution to change implementation and analysis requests.
  • Review vendor failure analysis reports for accuracy.
  • Assess the impact of changing regulatory standards on existing medical products, and assess the impact of changes in medical products against existing regulatory standards.
  • Typical issues are reactive and are often urgent, so priorities change frequently, and issues must be resolved promptly. Some issues requiring resolution may contain a mechanical element as well.
  • Leverage area expertise and learn new design elements to quickly become the design expert as issues require.

 

Preferred Qualifications:

  • Experience in the development or support of medical products
  • Experience working in or with a manufacturing environment
  • Experience in a regulated industry
  • Experience with quick turn assignments
  • Proven experience working effectively both independently and with multi-functional teams


Posted: July 24, 2017, 2:33 pm
Category : Software Engineer
Job Type : Contract
Id : 7022
Region : Twin Cities

Seeking a Software Engineer to be responsible for defining, implementing, executing, and documenting software for the next generation of Company software products. The activities will encompass all facets and phases of software engineering, meeting all regulatory standards, to realize complex, innovative, high reliability systems that improve the quality of life of people around the world. 
As a Software Engineer, you will be working with a motivated, diverse, and knowledgeable development teams to deliver world-class products. 
This role requires the ability to understand moderately complex technologies, coupled with the technical skills to transpose both into exceptional products that delight users. This is a highly trusted position that requires an individual to think independently, be decisive, and need minimum supervision. 

POSITION RESPONSIBILITIES: 

  • Work in a team of software engineers to the design, develop, and verify software products in an agile environment (SAFe). 
  • Support the test automation strategy and implementation. 
  • Meet all project milestones and deliverables, as required by the project leadership. 
  • Assist in creating and maintaining product documentation (requirements, specification, design, development, integration, test procedures and results). 
  • Provide concise, timely, and accurate reports and status of all test activities. 
  • Participate in continuous process improvement activities. 
  • Apply best practice techniques to meet all regulatory compliance requirements. 
  • Keep abreast of technical and industry trends related to Software Design and development 

 

SKILLS/EDUCATION REQUIRED: 

  • Bachelor's Degree in related field and 2+ years' experience or
  • Master's Degree in a related field and 1+ years' experience
  • 1+ years' experience with Andriod development. 
  • 1+ years' experience with Java development and Object Oriented Design. 

 

PREFERRED QUALIFICATIONS:

  • BS and/or MS in Computer Science, Software Engineering or Computer Engineering. 
  • Demonstrated successful implementation of a software application in a prior environment
  • Demonstrated excellent written and verbal communication skills. 
  • Knowledge of software test architecture and software tools for Web and mobile software applications. 
  • Experience with layered architecture, MVC, Design Patterns 
  • Experience with HTML5, CSS, JavaScript and JavaScript frameworks
  • Experience defining XML and JSON 
  • Knowledge of wireless network technologies. 
  • Experience with configuration management tools and best practices (GIT, SVN, etc.). 
  • Good understanding of Continuous Integration environments (Jenkins, Bamboo, ElectricCloud) 
  • Understanding of basic Agile Tools (Rally, VersionOne, Jira) 
  • Ability to generate concise and timely report, including project metrics. 
  • Good understanding of REST based web services 
  • Understanding of multitenant/multi- user paradigm 


Posted: July 24, 2017, 12:03 pm
Category : Project Manager
Job Type : Contract
Id : 7021
Region : Twin Cities

We are seeking an experienced Project Manager to organize and coordinate the design and development program for a patient mobile application.

 

POSITION RESPONSIBILITIES

  • Responsible for project planning including identifying requirements, developing work plans, managing project budgets, building project schedules, and partnering with team members to determine and communicate functional and resource requirements.
  • Guide functional teams including, but not limited to Human Factors, User Experience Design and Systems Engineering working on the Patient Mobile Application
  • Responsible for managing execution against an aggressive project plan, provide project-related work direction to team members, work with peer project managers and cross functional program team members to monitor dependencies and ensure that critical program milestones and deliverables are met.
  • Build stakeholder and internal team communication strategy, tools, and cadence. Anticipate communication cross program communication points.
  • Create meeting agendas and proactively manage action items to hold team members accountable to the project scope, budget, and schedule.
  • Proactively manage project quality, change, risks, and issues.
  • Provide project team members with a clear vision and purpose for the project, and create a positive tone and morale for the team. Motivate team members and build project team identity and cohesion. Ensure cross-discipline coordination and communication.
  • Provide input for setting team member's performance objectives and provide feedback to the functional leaders about performance against project deliverables and core competencies. Provide ongoing feedback and coaching to team members as appropriate, keeping the functional leader informed of performance and progress.

BASIC QUALIFICATIONS

  • Proven experience as a Project Manager
  • Thorough understanding of project management techniques and methods
  • Excellent knowledge of performance evaluation and change management principles
  • Demonstrated track record of successfully delivering on projects in a matrixed environment.
  • Excellent knowledge of MS Office; working knowledge of program/project management software (MS Project, SharePoint etc.) is a strong advantage.
  • Outstanding leadership and organizational skills.
  • Excellent communication skills and problem-solving ability.
  • Understanding of the Software Development Life Cycle.
  • Managing geographically distributed teams.
  • Track record of effective vendor management to deliver results.
  • Proven record of influence management, stakeholder communication, and project management

EDUCATION REQUIRED

  • Bachelor's Degree with 7+ years' experience leading software development projects and multi-disciplinary teams and/or related experience leading projects

DESIRED/PREFERRED QUALIFICATIONS

  • Experience working in regulated environments and delivering new products in compliance with global regulatory standards.
  • PMP Certification.
  • Medical Device Industry or related experience.
  • Prior experience of working on mobile app development.
  • Masters in Software or Computer Engineering or MBA.

 



Posted: July 21, 2017, 10:38 am
Category : Software Test Engineer
Job Type : Permanent
Id : 7019
Region : Twin Cities

Seeking a Software/Firmware Test Engineer to be responsible for creation and execution of software and firmware verification tests for medical devices, and generation of all related plans, specifications, reports, and other documentation.

 

ESSENTIAL DUTIES & RESPONSIBILITIES:

  • Verify application software and firmware for commercial medical products, software test environments, clinical investigations, and related uses.
  • Create test plans for product software and firmware. Identify testable requirements and write test scripts based on identified requirements. Execute tests and document the results of testing.
  • Work closely and collaboratively with other software engineers. May be required to delegate portions of the verification process to others.
  • Document work in a clear and complete manner.  Create test requirements, test plans, test reports, and other documents for the product that are specific and correct with minimal supervision. 
  • Provide feedback to the Software Director on the software test schedule to ensure schedule tracking and updating is straightforward.
  • Provide input to the electrical design group regarding testing equipment and prototype or production hardware required to perform software verification tasks.

 

SKILLS & EXPERIENCE:

  • Bachelor's degree (or higher) in Electrical Engineering or Computer Science or an equivalent level of skill gained in work experience.
  • A minimum of 10 years' experience verifying software applications for PC and tablet based medical devices as well as firmware applications for medical products is required.
  • Effective technical leadership skills, associated with excellent written and verbal communication skills, are necessary.
  • A strong knowledge of test development for Win 7 and Win 10 platforms using Microsoft Visual Studio, C#, .NET Framework 4, and XML is essential.
  • Must have the ability to derive software test requirements from schematic and system-level documentation.
  • Must have ability to use electrical test or diagnostic equipment, such as oscilloscopes, logic analyzers and voltmeters.
  • Must have experience with software test development for medical devices consistent with ISO 9001 and FDA Quality System Regulations to test requirement specifications, and design documents.
  • Will use quality techniques such as code inspections, and black-box/white-box testing. In addition, the individual must generate validation reports that will pass scrutiny of regulatory and compliance agencies that govern the medical device industry.
  • Experience testing applications with Cloud based data management is desired.


Posted: July 20, 2017, 12:48 pm
Category : Electrical Engineer
Job Type : Contract
Id : 7018
Region : Twin Cities

Immediate opportunity for Electrical Engineer to support design of embedded medical device products. Primary responsibility is schematic design and PCB layout for new and updated designs. The engineer may also support prototype development, test, and ESD/EMC

 

Requires BSEE and experience in analog and digital circuit design, and PCB design / layout using PADS, Altium, or similar tools.  Prefer experience in medical device / FDA design procedures and documentation, and ability to support product development in a fast paced environment.



Posted: July 20, 2017, 6:52 am
Category : Quality/Regulatory
Job Type : Contract
Id : 7017
Region : Twin Cities

 

Seeking a Senior Reliability Engineer to provide key technical expertise and leadership. This role is focused on understanding and improving product performance monitoring, issue management, and continuation engineering.  As such, this Senior Engineer is expected to: Have excellent communication and documentation practices, Develop solutions to technical problems that require regular use of ingenuity and creativity, Understand therapy and clinical performance, products, and product use environments to appropriately and strategically apply technical knowledge, tools and methodologies to drive reliability monitoring and issue escalation. Represent the organization as a technical contact for reliability.

 

POSITION RESPONSIBILITIES:

This role supports continuation engineering and manufacturing operations. As such, this senior reliability engineer is focused on maintaining the design integrity through post market changes and supporting/resolving quality issues that arise during production and use. Tasks include:  Reviewing and approving changes to designs and processes, and assessing their impact to assure reliability requirements are met, Providing input for Regulatory submissions, Participating in establishing and reviewing specifications/requirements for components, products and processes.

 

EDUCATION REQUIRED:

  • Bachelor's degree in Engineering
  • 3+ years with Bachelor's degree in engineering, science, or related field.
  • 1+ years with Master's degree in engineering, science, or related field
  • 0+ years with PhD in engineering, science, or related field.

REQUIRED SKILLS:

  • Experience and success working with multi-disciplinary teams.
  • Proven ability to operate in a matrix organization and navigate complex business systems, regulations, standards, and performance requirements
  • Demonstrated critical thinking skills with focus on improved system performance outcomes and positive business impact
  • Excellent problem solving skills, including demonstrated application of structured problem solving methods and tools
  • Strong written and oral communication skills (timely, clear, concise, accurate, conclusive, influential, targeted to audience)
  • Strong collaboration and influence skills (build relationships, leverage others, align and work towards shared outcome-based goals, understand others' needs, negotiate for win-win, own the whole)
  • Fluent in English (both oral and written)
  • Proficient in word processing, spreadsheets, and managing electronic data files

PREFERRED QUALIFICATIONS:

  • Understanding of Company products and their use in the clinical environment
  • Experience in a highly regulated industry, preferably implantable medical devices
  • Advanced degree in engineering, science, or equivalent field
  • Reliability engineering experience, including product performance modeling and trending
  • Exposure to or experience working in or with Design, Quality, Regulatory, Clinical and/or Manufacturing
  • Knowledge of Design for Reliability (DfR), Design for Reliability and Manufacturability (DRM), and robust design practices
  • Certified Reliability Engineer (CRE), or equivalent certification
  • Experience working across geographies and cultures

 

Posted: July 19, 2017, 2:11 pm
Category : Manufacturing Engineer
Job Type : Permanent
Id : 7016
Region : Twin Cities

Looking for a unique candidate for dual role as a Senior Manufacturing Continuous Improvement Engineer.  The candidate will be responsible for implementing Lean/Six Sigma methodology across Company business and be responsible for manufacturing engineering product support.  This candidate will be the site change agent for process and product quality improvements to drive culture change using world-class manufacturing best practices and have the ability to influence behaviors across entire organization.  In parallel, the candidate will also focus on New Product Development (NPD), process documentation, sustaining manufacturing process, and product yield.

 

Key Responsibilities:

  • Lead culture change by driving Lean and Six Sigma breakthrough strategies across entire organization by focusing on site business initiatives.
  • Lead, coach, mentor team members through completion of project. 
  • Problem solving leadership using 5 Whys, 8D, DMAIC, and Kaizen Events.
  • Analyze manufacturing process flows continually for the enhancements of quality, cost reduction, and increase throughput.
  • Define department metrics and report results of manufacturing fixture yields and plans for improvement.  Including identification of product yield, scrap cost, rework, and Continuous Improvements for factory operations.
  • Specify design criteria for manufacturing technologies and concepts.  Provide reproducibility and manufacturing expertise for NPD activities and the design to production transition processes.  This includes designing and developing manufacturing processes for enhancements, product changes, new products, and related fixtures and tooling that are consistent with zero defect level and low product cost. 

 

Experience Required:

  • Bachelor's degree in an engineering or related field.
  • Minimum of 7+ years of experience in a manufacturing environment or 5 years of experience with a Master's Degree.
  • Lean or Design for Six Sigma (DFSS) Green Belt certified.  Ability to demonstrate Lean/Six Sigma methodology implementation across all organization including factory operations using strong influence capability and ability to divert decision making.
  • Experience with fixturing, knowledge of optical, electrical and mechanical assembly.
  • Experience in statistical applications tools such as Minitab, Excel, or JMP.
  • Proven track record of success manufacturing NPD readiness review.

 

Experience Preferred:

  • Experience with optomechanical / electromechanical assembly operations.
  • Certified Lean Expert or Six Sigma Black Belt. 
  • Coach and mentor cross-functional team on manufacturing Six Sigma tools such as First Pass Yield, Process Map, FMEA, and Control Plans.
  • Excellent statistical analysis and hypothesis testing using analytical skills.
  • Self-motivated, must be able to lead and coach teams, promote change and execute multiple large projects simultaneously.


Posted: July 18, 2017, 9:08 am
Category : Quality Engineering
Job Type : Contract
Id : 7015
Region : Twin Cities

Looking for an entry level Supplier Quality Engineer to perform all aspects of engineering activities in compliance with applicable industry/regulatory standards and company quality objectives.

 

Position Responsibilities:

  • Support quality system integration as it relates to supplier management and purchasing controls including audit, ASL, Quality Agreements, supplier and product risk assessment, change control, etc.
  • Provide Engineering support to Sourcing team in support of Supplier Performance.
  • Lead or participate in the audit/assessment of current or future suppliers ensuring they are compliant with associated Company policies and Quality System requirements
  • Identify and manage risk throughout the supplied material process with the use of risk management tools. This includes incorporating elements from the design process and working with the manufacturing department to ensure material requirements are correctly identified for and met by suppliers.
  • Manage supplier change notification program through risk based evaluation
  • Provide input to design and manufacturing documentation including material specifications, drawings, inspection procedures, and manufacturing procedures, to ensure that the resulting products can be adequately manufactured and tested
  • Assist with the analysis and resolution of design or manufacturing material issues as these arise
  • Participate in supplier selection process and specification reviews with suppliers to ensure that purchased components/materials meet Company specifications
  • Specify quality characteristics and inspection plans for components, subassemblies, and finished devices
  • Comply with applicable FDA and international regulatory laws/standards and Company Standards

 

Education Required:

  • Bachelor's Degree in applicable Engineering field


Posted: July 18, 2017, 6:19 am
Category : Electrical Designer
Job Type : Permanent
Id : 7011
Region : Twin Cities

Looking for a Senior Electrical Design Engineer who will be responsible for creating innovative, functional, and robust product designs for Class III active implantable medical devices using state of-the-art techniques and tools. Primary responsibility is to design, prototype and test the systems electrical components with emphasis on the implantable neuroregulator, external charger, and leads.

Essential Functions:

  • Provide design, simulation, and analytical support for the development of Company products
  • Provide conceptual design, detail design and prototyping, supplier selection, performance testing, and project management.
  • Partner with manufacturing, marketing, quality, and regulatory to ensure that the final product meets customer requirements, as well as company performance, schedule, and cost targets.
  • Provide electrical  design and analysis support for various research-based preclinical test systems.
  • Plan, create, analyze, and refine electrical designs generating schematics, BOMs, AMLs, and PCB layout using electronic design tools.  Develop product specifications and test protocols.  Support the development of requirement documents and production test requirements.  Manage production test development.
  • Plan and perform product evaluation testing traceable to system level requirements. Design and qualify test methods, analyze and communicate test results and rationale behind design decisions to other development team members and management staff, and generate test reports. Coordinate compliance testing with outside test services.
  • Participate with cross-functional development team members in performing risk analysis, FMEA (failure modes and effects analysis), DVT (design verification testing), DFM (design for manufacturability), and component reliability.
  • Evaluate suppliers, consultants, and technical experts and make necessary recommendations. Work with suppliers to create new designs and/or processes.
  • Provide work direction and coordinate activities for CAD Designer and R&D technicians.
  • Adhere to Company Design and Development Standard Operating Procedures (SOPs) and maintain design history file. Possess an understanding of  Company configuration management and change order system.
  • Perform returned product analysis
  • Test fixture design, test method development, and support for product testing and inspection from time to time.

Minimum Requirements:

  • Master's degree in Electrical Engineering is preferred; a bachelor's degree is acceptable provided the individual possesses the requisite design experience.
  • 10+ years electrical design experience working with medical devices is required in addition to a proven track record of bringing medical products from initial concept design through commercialization.
  • A broad knowledge of all aspects of electrical engineering involved in the development of active implantable medical devices including medical product safety standards, EMC standards, and regulatory requirements.
  • Ability to work with circuit assemblies, surface mount components, and associated schematic capture and PCB layout tools.
  • RF design including inductively coupled systems, resonant tank circuits, antenna design, feed throughs, reed switches, and custom inductors.
  • Analog design including voltage conversion, battery charging circuits, H-bridge circuits, filter, switching power supplies, and electrical isolation.
  • Digital design including PIC processors, D to A, A to D, EEPROM, Flash, SPI, and serial communications.
  • Portable system design with rechargeable batteries.
  • Circuit simulation, software programming, FPGA design, and ASIC design skills are preferred.
  • Working knowledge of statistical analyses and basic computer knowledge including MS Word, Excel, and Project.
  • Must be flexible in responsibilities, an excellent communicator, both written and orally, and an exceptional problem solver with the ability to implement appropriate solutions.


Posted: July 12, 2017, 9:45 am
Category : Mechanical Designer
Job Type : Permanent
Id : 7012
Region : Twin Cities

Looking for a Senior Mechanical Design Engineer who will be responsible for creating innovative, functional, and robust product designs for Class III active implantable medical devices using state of-the-art techniques and tools. Primary responsibility is to design, prototype and test the systems mechanical components with emphasis on the implantable neuroregulator, external charger, and leads. The Senior Mechanical Design Engineer will provide design, solid modeling and analytical support for the development of the product.

ESSENTIAL FUNCTIONS

  • Provide conceptual design, detail design and prototyping, supplier selection, performance testing, and project management.
  • Partner with manufacturing, marketing, quality, and regulatory to ensure that the final product meets customer requirements, as well as company performance, schedule, and cost targets.
  • Provide mechanical design and analysis support for various research-based preclinical test systems.
  • Plan, create, analyze, and refine mechanical designs using SolidWorks 3-D solid modeling and document the designs with specifications and drawings.
  • Evaluate physical design using rapid prototyping.
  • Develop product specifications and test protocols.
  • Support development of requirement documents and production test requirements as well as production test development.
  • Plan and perform product evaluation testing traceable to system level requirements.
  • Design and qualify test methods, analyze and communicate test results and rationale behind design decisions to other development team members and management staff, and generate test reports.
  • Coordinate compliance testing with outside test services.
  • Participate with cross-functional development team members in performing risk analysis, FMEA (failure modes and effects analysis), FEA (finite element analysis), DVT (design verification testing), DFM (design for manufacturability), and tolerance analysis.
  • Evaluate suppliers, consultants, and technical experts and make necessary recommendations. Work with suppliers to create new designs and/or processes.
  • Provide work direction and coordinate activities for CAD Designer and R&D technicians.
  • Adhere to Company Design and Development Standard Operating Procedures (SOPs) and maintain design history file.
  • Work within the constraints of Company configuration management and change order system.
  • Perform returned product analysis as well as packaging design, test fixture design, test method development, and support for product testing and inspection from time to time.

MINIMUM REQUIREMENTS

  • Master's degree in Mechanical Engineering is preferred; a bachelor's degree is acceptable provided the individual possesses the requisite design experience.
  • 10+ years mechanical design experience working with medical devices is required in addition to a proven track record of bringing medical products from initial concept design through commercialization.
  • Deep understanding of materials and processes commonly used in the development of medical products. Thermoplastic molded part design experience is required.
  • Experienced user of solid modeling systems and related analytical tools. Experience in file transfer to suppliers for rapid prototyping, mold flow analysis, mold construction, and other similar activities in addition to design for manufacturability experience.
  • Knowledge and understanding of how system requirements including product packaging and labeling impact the overall product design
  • Broad knowledge of all aspects of mechanical engineering involved in the development of active implantable medical devices including medical product safety standards, biocompatibility, and regulatory requirements.
  • Working knowledge of statistical analyses and basic computer knowledge including MS Word, Excel, and Project.
  • Must be flexible in responsibilities, an excellent communicator, both written and orally, and an exceptional problem solver with the ability to implement appropriate solutions.


Posted: July 12, 2017, 9:15 am
Category : Quality Engineer - Medical Device
Job Type : Permanent
Id : 7013
Region : Twin Cities

Looking for a Senior Quality Systems Specialist who will be responsible for the implementation and maintenance of elements of an FDA QSR and ISO 13485 compliant quality system. This Candidate will administer critical functions of the Quality Management System including the document management, training, calibration, and the company safety program. Also, support regulatory submissions and operations as required.

ESSENTIAL FUNCTIONS

  • Coordinate and administer New Hire Training Program for Quality Systems. This includes working with management to establish requirements, maintaining training materials, delivery of training, and ensuring appropriate documentation is completed.
  • Facilitate the document management and change control system in accordance with Company procedures. This includes serving as the change coordinator in the electronic document management system and assisting users with document management activities.
  • Support administration of the eQMS software (Grand Avenue System) to support the QMS needs.
  • Manage the Company CAPA system ensuring compliance to the Company process.
  • Provide support activities to Supply Chain with regard to maintenance of the Approved Supplier List.
  • Serve the role of the Audit Program Coordinator. This role is responsible for managing the Internal Audit Program. Interfacing with third party auditors both the Notified Body auditors and the contracted internal auditors. Conduct internal audits when applicable such as the clinical research process.
  • Serve as the Calibration Coordinator. Coordinate the Calibration and Preventive Maintenance Program including assigning equipment numbers, maintaining the equipment list, scheduling calibration suppliers, and reviewing calibration certificates.
  • Serve as the Standards Coordinator. Manage the External Standards program, including performing annual standards review, working assignment and tracking of change assessments, and ensuring currency of the standards database.
  • Provide support for the development, submission, and maintenance of regulatory filings as required.
  • Lead the facility safety program including performing audits, delivering training, performing/scheduling safety related maintenance projects, and maintaining records.
  • Contribute to the development, analysis, and production of metrics to monitor and improve the quality system and support management review.

MINIMUM REQUIREMENTS

  • Bachelor's Degree in technical field. (Appropriate experience may be substituted for degree.) Position may be modified for personnel with exceptional qualifications
  • 7+ years' experience working in the medical device industry, preferably with active implantable devices.
  • Working knowledge of FDA QSR and/or EN ISO13485
  • 4+ years' experience implementing and maintaining elements of a quality system, including CAPA, internal/external audits, nonconforming material, management review, document control, training, and/or calibration.
  • Auditor experience desired (CQA or other auditor certification preferred)
  • Experience with electronic QMS or PLM systems required. Experience with Grand Avenue Software preferred.
  • Excellent verbal and written communication skills


Posted: July 12, 2017, 9:08 am
Category : Mechanical Engineer
Job Type : Contract
Id : 7008
Region : Twin Cities

Seeking a Principal Facilities Design Engineer – Clean Room Specialist to lead and direct mechanical systems related projects including schematic system design, vendor selection, and project execution for projects that span across functional and geographical organizations. Prepare concept designs, project execution plans and engage appropriate technical resources needed for the team. Ensure projects are completed on schedule, within budget and meet the requirements of the assignment. This Candidate will be a key team member on all Facility projects, involving mechanical systems and building automation design. Keep current on advances in the field of Mechanical Engineering and Building Systems Design.

 

POSITION DUTIES:

  • Provide technical expertise and act as the lead in mechanical system specific projects from concept design, engineering, implementation, and commissioning.
  • Provide technical expertise for the Mechanical aspects of all facility related projects as an active project team member.
  • Undertake Engineering evaluations of current and new assets to develop corrective/preventative maintenance plans and long-term upgrade strategies for critical mechanical systems.
  • Partner with the Global Energy Management team on all mechanical systems projects assuring projects are designed and executed with a strong focus on energy reduction.
  • Partner with the Maintenance teams, providing technical expertise for systems operation, building automation and controls, preventive and corrective actions, capital planning, and capital improvement projects.
  • Provide technical expertise and guidance on all cleanroom related projects, including the development of global standards for the design, construction, commissioning, validation, and operations of cleanrooms.
  • Review status of the projects and budgets; manage the schedules and prepares status reports. Monitor the project from initiation through delivery and close out. Assess project issues and develops resolutions to meet budget, schedule and client-satisfaction goals and objectives. Use mechanisms for monitoring project progress and for intervention and problem solving with project team members, management and clients.
  • Help develop the Quality Management System and apply its principles to all projects involving regulated space and equipment serving regulated space.

 

BASIC QUALIFICATIONS:

  • 10+ years of relevant professional experience
  • Bachelor of Science Degree in Engineering
  • Specific experience managing large-scale projects of varying degrees of complexity and financial magnitude
  • Track record of meeting aggressive schedules and budgets
  • Experience participating on highly collaborative team
  • Experience supervising external resources/vendors
  • Experience leading projects in a regulated clean room manufacturing environment

 

PREFERRED QUALIFICATIONS:

  • Demonstrated track record of leading within complex organizations requiring strong influence management skills
  • Results oriented with strong customer focus and satisfaction skills
  • Ability to communicate effectively, both orally and in writing, with all levels of management and with facilities professionals
  • Excellent interpersonal skills with demonstrated ability to interface with all levels of management and outside service providers
  • Ability to delegate effectively
  • Independent decision making and problem solving skills
  • Ability to coordinate numerous projects simultaneously
  • International business experience
  • Strong negotiating/influence management skills
  • Knowledge of construction and facility management concepts, techniques and terminology
  • Computer Literate - PC. Proficiency in Excel, Word, Microsoft Project and PowerPoint
  • Ability to travel both domestically and internationally up to 25% of time
  • Professional Engineer (PE)
  • Participate in peer associations, (i.e. ASHRA)


Posted: July 11, 2017, 8:41 am
Category : Manufacturing Engineer
Job Type : Permanent
Id : 7005
Region : Wisconsin

Seeking an experienced Project Engineer to work with customers on bringing products from development through clinical build.  The candidate will work on a variety of products and customers in the medical device/drug delivery system industry. Knowledge of tooling, design, and manufacturing development are all important in this role, as well as good customer facing skills. 

 

Responsibilities:

  • Coordinate, direct and lead engineering efforts to ensure optimum engineering of projects/programs to meet customer and manufacturing requirements
  • Interface with customers on a regular basis to resolve issues
  • Facilitate communication between customer, sales, engineering functions, outside vendors, manufacturing and multi-facility groups
  • Maintain cost control and profitability through interaction with the accounting group, sales and our customers
  • Coordinate all aspect of a program including design, tooling, manufacturing development, validation and clinical builds from early concept development through the clinical build process.
  • Create and monitor project timelines
  • Develop and establish cost estimates and project options to support quoting function
  • Implement technical solutions to meet customer and Comapny cost, quality, and delivery expectations
  • Extended travel to other facilities may be required to support business needs
  • Some programs may have vision requirements

 

Education & Experience:

  • B.S. degree in engineering field with 2-5 years of related experience

Skills & Competencies:

  • Strong and diverse technical injection molding tooling, materials, manufacturing, quality, and product design skills
  • Ability to use CAD to determine if tooling, equipment and part designs meet requirements
  • Ability to manage multiple large-scale projects
  • Demonstrated superior communication, teamwork and organizational skills
  • Ability to accurately quote design, tools/equipment, and parts
  • Ability to develop and meet project schedules, along with contingency plans
  • Ability to develop and meet financial goals
  • Ability to identify and develop future account needs
  • Ability to think out of the box and recommend options
  • Ability to lead others.  Responsibility may include direct supervision of technicians and mentoring/leading engineers
  • Broad understanding of capabilities and technologies of other Company facilities, suppliers, and customers


Posted: July 10, 2017, 9:56 am
Category : Electrical Engineer
Job Type : Contract
Id : 7003
Region : Twin Cities

Looking for a Controls Engineer to be responsible for designing, implementing, commissioning, and supporting controls, software, and data acquisition systems.  This role requires autonomy and individual drive to successfully execute project deliverables, yet also requires collaboration with other engineers, projects managers, and customers.   This role is a blend of hardware and software capabilities and requires a systems level perspective in order to properly integrate a complete and high quality solution.

 

Job Requirements:

  • Deliver production-ready designs, system drawings, parts lists, functional specifications, software, and reports for the control and data acquisition of wind tunnels, facility control, and engine test systems
  • Design and implement complex software using LabVIEW and IEC 61131 languages
  • Deliver high quality engineering service on schedule and within budget
  • Demonstrate effective individual task management while working within an interdisciplinary team environment
  • Interface with various transducers, instrumentation, and peripherals through a variety of interfaces and protocols.  Examples of this include load cells, servo valves, thermocouples, limit switches, MIL-STD connectors
  • Provide input and guidance concerning potential use and benefit of emerging technologies
  • Gather technical specifications and designs from key stakeholders and customers to determine and create test system controls and software/hardware specifications
  • Travel to customer sites for design reviews, site surveys, and system commissioning.   Travel is both domestic and international
  • Oversee the implementation and release of system drawings by working with CAD designers to produce specifications and design drawings
  • Support or perform system assembly, checkout, and site installation
  • Develop high quality documentation such as operations manuals, test procedures, design specifications, and validation plans
  • Ensure compliance with design criteria and customer, government, and ASE engineering standards

 

Qualifications/Education:

  • Bachelor's degree in Engineering
  • 2 to 5 years of relevant experience implementing automation systems
  • Working knowledge of electronics and electrical systems used in systems test, automation and control applications
  • Working knowledge of instrumentation schematics and system wiring diagrams
  • Working knowledge of electro-mechanical and electro-hydraulic systems
  • Excellent problem solving and troubleshooting capabilities
  • Excellent written and oral communication skills, demonstrated initiative, and attention to completeness, accuracy, and detail
  • Ability to work alone effectively and interface productively with customers, project managers, engineers, and other staff
  • Demonstrated ability to meet budgets and schedules
  • Willingness to travel for business - up to 20%
  • Due to the nature of our work US citizenship or permanent residency is required


Posted: July 6, 2017, 12:20 pm
Category : Technicians
Job Type : Contract
Id : 7001
Region : Twin Cities

Seeking an Electrical Design Technician to develop and execute electrical tests to characterize or verify the functionality of hardware systems. Work closely with engineers to design and redesign devices, fixtures, test systems and components.  Evaluate preliminary designs for compliance with specified requirements.

 

POSITION RESPONSIBILITIES:

  • Perform a variety of technical duties including design, assemble, and test unique hardware and software test systems with minimal engineering input 
  • Perform circuit characterization and design verification tests, analyzing and reporting results using spreadsheets, tables and graphs 
  • Hardware circuit performance analysis and troubleshooting on analog and digital circuits 
  • Contribute to design documentation that is required by Quality Systems and recommend changes as needed
  • Work closely with engineering and test partners, participating in design reviews, troubleshooting strategy, and issue resolution 

 

BASIC QUALIFICATIONS:

  • Must be able to read electrical schematics and have an understanding of analog and digital circuits and be able to operate test equipment such as Oscilloscopes,
  • logic analyzer, counters, etc.
  • 2+ years of LabVIEW programming experience with the ability to create automated test setups
  • Able to collect test data utilizing automated and manual test techniques
  • Desire and ability to work effectively and efficiently in a team environment.  Ability to multi-task in a fast-paced environment 
  • Good prioritization and verbal/written skills
  • Good working relationship with peers; able to create a positive work environment

 

EDUCATION/SKILLS REQUIRED: 

  • Two-year electronics degree or equivalent.  
  • 2 years in an electrical test environment
  • Medical device design or experience in other highly regulated environments (Military, Government, etc.)
  • Use of high end test equipment and or custom test setups to perform evaluation, characterization, or verification of electric designs
  • Ability to working closely with other technicians and design engineers to evaluate new electrical designs and execute verification tests by collecting data and providing detailed reports after test completion

 

PREFERRED SKILLS:

  • Research clinical and market released systems
  • Animal and human clinical studies
  • Electro-mechanical test experience
  • Understanding of Company therapies and diagnostics
  • Test development and operation using LabVIEW
  • RF test
  • MRI test
  • Test systems simulation
  • Test instrument build
  • Programming experience using LabVIEW, C++ or C#
  • Experience using IEEE488 instrumentation

 

Posted: July 5, 2017, 8:42 am
Category : Systems Engineer
Job Type : Contract
Id : 7000
Region : Twin Cities

Seeking a Systems Engineer to be responsible for the deployment and support of continuous improvement activities across the Systems Engineering discipline, and creation of system engineering validation strategies to validate products performance as designed and as intended for all users.

 

General Responsibilities:

  • Work under only general direction. Independently determine and develop approach to solutions. Work is reviewed upon completion for adequacy in meeting objectives.
  • Lead and provide work direction to technicians executing test activities. Ensure the test team understands the testing to be performed and correctly executes these activities in a timely manner.
  • Contribute to the completion of specific programs and projects.
  • Support system integration, supportability and effectiveness analyses for total systems. Work closely with partners to ensure adequate coverage between system integration, system verification, and system validation efforts.
  • Ensure the logical and systematic conversion of customer or product requirements into system validation strategies and procedures that confirm the behavior of the system meets requirements, specifications, user needs, and intended use, that effectively utilize project resources and acknowledge technical, schedule, and cost constraints.
  • Identify, propose, and assist in the implementation of process improvement initiatives. Identify organization strengths and weaknesses related to system testing and help create strategy for improvement.
  • Expected to balance a complex work load while delivering timely completion of team based activities.
  • Ensure all commitments are met. Provide input for project and departmental schedules, and communicate progress concerns in a timely manner and provide alternative solutions.

 

Minimum Requirements:

  • B.S. in Engineering or related field with 7+ years of experience.
  • M.S. in Engineering or related field with 5+ years of experience.
  • Complete understanding and wide application of technical principle, theories, and concepts in the field.

 

Posted: July 3, 2017, 2:18 pm
Category : Manufacturing Engineer
Job Type : Contract
Id : 6998
Region : Twin Cities

Seeking a Tooling Engineer to own and drive quality, continuous improvement, and cost savings initiatives with key suppliers and contract manufacturers in order to assure an uninterrupted supply of the highest quality product at the lowest price with zero production downtime.  Actively partner with key suppliers, contract manufacturers, and OEMs to resolve technical issues and to develop and complete various levels of raw material and finished device qualifications (primary area of focus for raw materials include: injection molding process/equipment and related tooling and resin processing. Secondary areas of focus are electronics, metals, and chemicals).  Ensure supplier processes are properly characterized, have adequate controls in place, and are properly monitored and reported on per required procedures, contracts, and applicable signed agreements.  Participate in Senior and Principal level engineering projects by taking direction from, and providing support to lead engineers.

 

Position Responsibilities:

  • Lead projects of moderate complexity associated with component(s) qualification – especially injection molded parts as related to mold design & physical properties of the selected polymer blend.
  • Develop a strong relationship with suppliers and act as a partner and advocate in order to resolve technical manufacturing and qualification issues. Adherence to guidance documents for internal & external requirements surrounding Process Development, OQ & PQ qualification runs and MSA activities.
  • Develop and maintain strong working relationship with functional stakeholders (R&D, Manufacturing Engineering, Supplier and Operations Quality, Post-Market Quality, Supply Chain, Marketing and Regulatory Affairs).
  • Review/prepare test protocols and reports in order to qualify part and product changes.
  • Provide technical assistance and guidance to suppliers and contract manufacturers performing qualification and validation testing.
  • Implement processes for component qualification that are aligned with company quality requirements, and FDA / ISO regulations and guidelines.
  • Drive part and product changes through the company Supplier Change Control and Change Order process.
  • Provide input into the design, reliability, and manufacturability of new products and coordinate activities within our supplier base. Work closely with component and quality engineers to ensure best practices are horizontally deployed across the value stream.
  • Proactively identify opportunities for supplier improvements, and formulate and execute plans to take advantage of those opportunities.
  • Drive processes for resolution of technical issues at key suppliers and contract manufacturers.
  • Manage engineering projects of varying complexity.
  • Ability & willingness to travel 25 - 50% of the time - often on less than 12 hrs. notice.

Education:

  • BS/BA degree in engineering or science with 2-4 years of relevant experience, or an advanced degree with a minimum of 2 years relevant experience.

Preferred Qualifications:

  • B.S. in Plastics Engineering
  • 2+ years of Injection Molding experience focused on tooling & scientific molding principles.
  • 2+ years in Medical Device Industry
  • MS degree in science or engineering, or MBA
  • Doc Writer software experience
  • Project Management experience
  • Injection molding tool design, build and repair
  • Rheology knowledge both Crystalline & Amorphous plastics resin (examples include polycarbonate, acrylic, PVC, Nylon and Co-polyesters)
  • Understanding of tool steel application for molds for improved operational performance, heat transfer, Rockwell Hardness & welding applications
  • Use of Society of Plastics Industry Standards (SPI) for cosmetic acceptance
  • Experience working with Contract Manufacturers and OEMs
  • Use and understanding of Statistical Tools (Design of Experiments, Measurement System Analysis, Process Capability and Statistical Process Control)
  • Development characterization and qualification protocols and reports (including structured DOE evaluation and/or IQ/OQ/PQ/PV documentation)
  • Understanding of Geometric Dimensional Tolerancing (GDT) and application for inspection setup and tolerancing allowances of molded components
  • Oral, Presentation and Written communication skills
  • Minitab, CAD program experience
  • Computer Skills (Microsoft Word, Excel, Project, PowerPoint)



Posted: July 3, 2017, 7:20 am
Category : Software Test Engineer
Job Type : Contract
Id : 6981
Region : Twin Cities

Seeking a Senior Firmware Development Engineer to be responsible for developing embedded firmware for medical devices, and generation of all related plans, specifications, reports, and other documentation.

 

Essential Functions

  • Develop, verify and support firmware applications for commercial medical products, firmware test, clinical investigation, and related uses.
  • Work closely with engineers and management in related disciplines including mechanical design, electrical design, firmware verification, and clinical research.
  • Provide significant amounts of work direction to other engineers and contract personnel as appropriate, effectively leveraging their skills within the department.
  • Communicate design tradeoffs to management and contribute to the decision making process on features and technologies.
  • Mentor and coach other team members in the group on system behavior, technical challenges and procedures.
  • Understand FDA requirements for medical device firmware and implement the necessary procedures and policies to show compliance to external regulatory bodies.
  • Generate requirements specifications, design specifications and review test specifications and other firmware related project documents necessary for FDA certification and product release.
  • Work closely with the Software Director and Project Manager to create and execute a credible schedule and project budget.
  • Lead the firmware development team and provide technical support for team members.
  • Specify and allocate units of work. Track progress and adjust allocation as necessary to compensate for changes, interruptions, and other issues to keep project on track.
  • Maintain a high level of expertise in firmware development concepts, practices and  procedures, and apply them to accomplish the task at hand.
  • Provide consultation to other teams and groups to resolve issues.
  • Assure that quality processes are followed by the firmware development team.

 

Minimum Requirements

  • Bachelor's degree (or higher) in Computer Science or Electrical Engineering or an equivalent level of skill gained in work experience.
  • 10+ years experience is required developing code for embedded microprocessor-based medical devices, with strong knowledge of C/C++ programming language and related tools (compilers, debuggers, source code control, testing firmware, etc.) 
  • 5+ years experience managing people and project budgets is required.
  • Experience with firmware development for medical devices that is consistent with ISO 9001 and FDA 21 Part 820 - Quality System Regulations and meets requirement specifications, design documents, and related quality techniques such as code inspections, block-box and white-box testing and validation reports.
  • Knowledge and understanding of the regulatory and compliance requirements that govern the medical device industry.
  • Strong knowledge of analog and digital circuits, down to the logic gate and block diagram level, and the ability to infer firmware requirements from schematic and system-level documentation is required.
  • Effective technical leadership skills, associated with excellent written and verbal communication skills are necessary. 
  • Ability to provide the necessary initiative and effective interpersonal skills that enable effective working relationships.

 

Posted: June 28, 2017, 2:41 pm
Category : Software Engineering
Job Type : Contract
Id : 6980
Region : Twin Cities

Seeking a Senior Software Development Engineer to be responsible for developing application software for medical devices, and generation of all related plans, specifications, reports, and other documentation.

 

Job Duties:

  • Develop, verify and support software applications for commercial medical products, software test, clinical investigation, and related uses.
  • Work closely with engineers and management in related disciplines including mechanical design, electrical design, software verification, and clinical research.
  • Provide significant amounts of work direction to other engineers and contract personnel as appropriate, effectively leveraging their skills within the department.
  • Communicate design tradeoffs to management and contribute to the decision making process on features and technologies.
  • Mentor and coach other team members in the group on system behavior, technical challenges and procedures.
  • Understand FDA requirements for medical device software and implement the necessary procedures and policies to show compliance to external regulatory bodies.
  • Generate requirements specifications, design specifications and review test specifications and other related project documents necessary for FDA certification and product release.
  • Work closely with the Software Director and Project Manager to create and execute a credible schedule and project budget.
  • Lead the software application development team and provide technical support for team members.
  • Specify and allocate units of work. Track progress and adjust allocation as necessary to compensate for changes, interruptions, and other issues to keep project on track.
  • Maintain a high level of expertise in software concepts, tools, practices and procedures, and apply them to accomplish the task at hand.
  • Provide consultation to other teams and groups to resolve issues.
  • Assure that quality processes are followed by the software development team.

 

Minimum Requirements

  • Bachelor's degree (or higher) in Computer Science or Electrical Engineering or an equivalent level of skill gained in work experience.
  • 10+ years of experience in developing applications for PC and tablet based medical devices is required with strong knowledge of Windows development for Win 7 and Win 10 using Microsoft Visual Studio, C#, .NET Framework 4, XML, WiX
  • Experience with software development for medical devices that is consistent with ISO 9001 and FDA 21 Part 820 - Quality System Regulations and meets requirement specifications, design documents, and related quality techniques such as code inspections, block-box and white-box testing and validation reports. 
  • Knowledge and understanding of the regulatory and compliance requirements that govern the medical device industry.
  • Effective technical leadership skills, associated with excellent written and verbal communication skills, are necessary. 
  • Ability to provide the necessary initiative and effective interpersonal skills that enable effective working relationships.
  • Experience with Cloud based data management is desired.


Posted: June 28, 2017, 2:36 pm
Category : Electrical Engineer
Job Type : Permanent
Id : 6992
Region : Twin Cities

Seeking a Controls Project Engineer for the design, programming, and management of industrial Control Systems Projects.

 

Position Requirements:

  • Bachelor's Degree in Electrical Engineering or Computer Science
  • 2-7+ years' experience with process and machine control design
  • Experience in PLC and MMI programming (Allen Bradley, Siemens, Wonderware, Panelview, Factory Talk), communication networks design and programming, electrical hardware / panel design, and system commissioning and start-up.
  • Up to 25% travel to customer sites

 



Posted: June 28, 2017, 11:34 am
Category : Manufacturing Engineer
Job Type : Permanent
Id : 6990
Region : Twin Cities

Seeking a Manufacturing Engineer to continuously improve the performance of the manufacturing process and transition planning from new product development to manufacture release through the use of continuous incremental improvements principals, specific projects, fixture discipline development, and continual evaluation of performance over time. The Manufacturing Engineer also has responsibilities including: process documentation, quality enforcement, and development of best practices in repeatable and sustaining manufacturing process. This position is accountable for the manufacture test and validation of products overall performance.

 

Position Responsibilities:

  • Analyzing manufacturing process flows continually for the enhancements of quality, cost reduction, and throughput.
  • Developing, evaluating, improving, and documenting manufacturing assembly procedures and manufacturing test processes. Support of manufacturing products and processes.
  • Conferring with assemblers, development and vendors in determining product specifications and arranging equipment, fixtures, parts, and evaluating products according to quality standards and specifications.
  • Define department metrics and report results of manufacturing fixture yields and plans for improvement.  Including identification of product yield, scrap cost, and rework required and Continuous Improvements for the factory.
  • Specify design criteria for manufacturing technologies and concepts.  Provide reproducibility and manufacturing expertise for new product development activities and the design to production transition processes.  Including designing and developing manufacturing processes for enhancements, product changes, new products, and related fixtures and tooling that are consistent with zero defect level and low product cost. 

 

Position Requirements:

  • Bachelor's degree in an engineering or related field.
  • Minimum of 5 years of experience in a manufacturing environment or 2 years of experience with a Master's Degree.
  • Experience with fixturing, knowledge of optical, electrical and mechanical assembly.
  • Ability to work effectively with cross-functional groups and ownership for products and processes assigned.
  • Lead inter-disciplinary teams to resolve high profile production issues and document recommend corrective actions in an 8D format.
  • Experience with implementing/facilitating continuous process improvements using Lean manufacturing principles. 

 

Position Preferred Qualifications:

  • Experience with optomechanical / electromechanical assembly operations.
  • Experienced in statistical applications tools such as Minitab, Excel, or Matlab.
  • Familiar with manufacturing process improvement Lean and Six Sigma tools First Pass Yield, Process Map, FMEA, and Control Plans.
  • Ability to lead and support cross-functional teams and effectively communicate technical information across all channels.
  • Self-motivated, with the ability to effectively coordinate multiple projects. 
  • Hands-on, team oriented individual possessing strong problem-solving and analytical skills. 


Posted: June 26, 2017, 10:04 am
Category : Electrical Engineer
Job Type : Contract-to-Hire
Id : 6968
Region : Minnesota

 

Seeking a Controls Engineer to design and program control systems for automated equipment.  The ideal candidate would have experience in AutoCAD, Allen Bradley, ControlLogix, Motion Control, Rs500, RsView, and PanelBuilder.  As a Controls Engineer, you will be responsible to take projects from concept to install.  Bachelor's degree in Electrical Engineering and 5 years relevant experience required.



Posted: June 14, 2017, 2:48 pm
Category : Management/Operations
Job Type : Contract-to-Hire
Id : 6967
Region : Minnesota

Looking for an experienced Production Manager Assistant to organize and oversee all assembly departments of a custom, manufactured automated machinery company. This person will be ultimately responsible for assisting the Production Manager in the smooth running of all phases of the assembly processes and the quality and the timeliness of the output. The ideal candidate should have deep knowledge of assembly production procedures, and the ability to direct personnel towards maximum performance.  Must have excellent decision making and problem solving skills.

 

Job Responsibilities:

  • Work with other managers to formulate objectives and understand requirements
  • Estimate work load and help prepare schedules, organize workflow to meet specifications and deadlines
  • Monitor production to resolve issues
  • Supervise and evaluate performance of production personnel (quality inspectors, workers etc.)
  • Determine amount of necessary resources (workforce, raw materials etc.)
  • Ensure output meets quality standards
  • Enforce health and safety precautions
  • Report directly to the production manager

 

Job Requirements:

  • Proven experience as an Assistant Production Manager
  • Deep knowledge of production management in a high volume custom machine building company to include but no limited to: machine design, electrical design, machining, welding, paint and other parts finishing, full machine assembly electrical and mechanical utilizing servos, AC-DC motors, bearings, pneumatics, hydraulics, all types motion hardware, machine safety equipment
  • Understanding of quality standards and health & safety regulations
  • Knowledge of performance evaluation and budgeting concepts
  • Experience in reporting on key production metrics
  • Proficient in MS Office and other software
  • Outstanding communication ability
  • Excellent organizational and leaderships skills
  • Attention to detail
  • Strong decision-making skills and a results-driven approach
  • Bachelors in business administration or relevant field  plus 5 years minimum relevant experience required
  • Some travel will happen as employee gets acclimated, maybe 20% depending on workload and desire to travel


Posted: June 14, 2017, 2:46 pm
Category : Electrical Engineer
Job Type : Permanent
Id : 6940
Region : Minnesota

Currently seeking a Senior Control Systems Engineer based out of the Los Angeles area to perform all aspects of a project, from conception and design, through start-up and checkout.  Duties include project management, P&ID development, wiring diagram development, BOM specification, control panel design, PLC and HMI programming, and field commissioning. This position has the ability to work from home (based in the Los Angeles area).

 

Required Skills:

  • Minimum of BSEE with 7+ years' experience or 2-year degree with 10+ years' experience
  • Ability to lead a project from conception through start-up
  • Project management, estimating, BOM specification, electrical diagram design, NEC
  • Experience using Wonderware products
  • Allen-Bradley RSLogix 5000, PowerFlex drives experience
  • Modicon PLC experience
  • Excellent communication and teamwork skills
  • Able to travel up to 35%

 

Desired Skills:

  • Motion Control
  • Experience in the mining industry
  • Experience with small manufacturing machines
  • Web Handling experience
  • PE Registration a big plus
  • Experience with MES

 

Posted: April 26, 2017, 9:06 am
Category : Machinist
Job Type : Permanent
Id : 6931
Region : Twin Cities

Seeking a Machining Supervisor to lead, supervise, and coordinate work activities within assigned Machine Shop and/or Tube Shop work centers (areas included are the CNC Lathes which include standard single spindle single turret, twin spindle twin turret and mill turn machines, Manual Machining, saw operations, and Anodizing).

 

Qualifications:

  • High school education or equivalent, plus at least 2 years of technical training in machine tool technology or a related field.
  • At least 5 years of CNC milling/turning/grinding set-up and operating experience, most of which must be in a short run environment involving a series of complicated operations. At least 2 years of experience in supervisory capacity includes.
  • Advanced knowledge of blueprint reading, geometric dimensioning and tolerancing, SPC, and mechanical inspection.
  • Advanced knowledge of shop math through trigonometry.
  • Knowledge of programming and multi-axis concepts in both manual and CNC environments.
  • Very strong mechanical aptitude and problem solving skills.
  • Ability to set-up, operate, and verify the quality of work on a wide variety of CNC and manual milling/turning work centers.
  • Experience with close tolerances and precise measurements.
  • Must exhibit strong leadership and sound decision making skills.
  • Ability to communicate effectively, both verbally and in writing, with a wide variety of company personnel and others at all levels.  
  • Ability to lead project teams and provide status updates.
  • Strong project management skills.
  • Ability to build a strong team through coaching and mentoring the staff.
  • Understanding of 5S and help implement continuous improvement efforts.
  • Displays a positive "can do" attitude and a strong desire to learn and grow.


Posted: April 17, 2017, 2:29 pm
Category : Electrical Assembler
Job Type : Permanent
Id : 6930
Region : Twin Cities

Seeking an Electrical Technician / Wireman to assemble and wire electrical control panels.  Must have the ability to read electrical prints, good electrical wiring skills, and ability to work independently.  Knowledge of UL508A standards is desired.

RESPONSIBILITIES:

  • Assembly & wiring of electrical control panel
  • Good electrical panel wiring skills
  • Ability to work independently or part of a larger project team
  • Ability to read electrical prints
  • Other duties as assigned

 

REQUIRED:

  • High School Diploma or GED
  • Experience in assembly and wiring
  • Ability to use hand tools
  • Good communication skills
  • Ability to prioritize and multi-task

 

DESIRED:

  • Knowledge of UL508A standards

Hourly rate possibly higher with experience



Posted: April 12, 2017, 12:09 pm
Category : Sales Engineer
Job Type : Contract-to-Hire
Id : 6880
Region : Twin Cities

Seeking a highly motivated professional who will provide pre-sale technical support to a growing sales team, to develop and complete quotes in all areas of automation.

 

Basic Responsibilities :

  • Support the sales team in the area of process controls, covering both hardware and software
  • Technical review of customer requests and preparation of bids and quotes for new projects and automation retrofits of customers' existing product lines
  • Provide technical presentations customized to customer needs
  • Communicate with customers and prospects on technical requirements and equipment capabilities in all aspects of industrial electrical installations
  • Present quotes to sales representatives and customers
  • Work together with the marketing team to create material used to promote company with online and tradeshow documentation and presentations
  • Create sales documentation for control systems and electrical installations
  • Work closely with teams in automation, sales, and technology
  • Travel to customers in US and Canada (Approx. 30%)

 

Required Qualifications :

  • Experience in plant/factory automation estimation
  • 5+ years of industry and technical knowledge in automation and electrical installations
  • Excellent oral and written communication skills
  • Proven ability to manage multiple projects while maintaining a high quality of work
  • Ability to read and understand schematics, drawings, and flowsheets
  • Familiar and basic knowledge with NEC, UL, NEMA
  • Ability to identify, evaluate, and problem solve
  • Flexible and self-starter
  • Positive, enthusiastic, and confident attitude
  • Excellent software skills (Outlook, Word, PowerPoint, Excel)
  • BS in Electrical Engineering or equivalent.

 

Posted: February 9, 2017, 1:25 pm
Category : Technicians
Job Type : Contract
Id : 6856
Region : Twin Cities

Immediate opportunity for an Automation Technician to support equipment build projects for medical device manufacturing. The Technician will assemble, test, and troubleshoot custom automated equipment and work cells. This includes electrical control panel wiring, motors, drive systems, mechanical enclosures, and PLC installations and check-out.

 

Preferred Skills

  • 2 year degree in Electronics or Automated Systems Technology
  • Hands on experience with equipment build
  • Must be able to read prints, schematics, and work instruction
  • Strong mechanical and electrical aptitude
  • Ability to work independently within a custom automation group
  • Knowledge and experience with PLC, HMI, and motion control
  • Medical device development environment experience is a plus



Posted: January 17, 2017, 2:33 pm
Category : Mechanical Engineer
Job Type : Permanent
Id : 6850
Region : Twin Cities

We are seeking a Mechanical Engineer that is responsible for the creation of mechanical designs that meet technical, project cost, and schedule criteria of projects. Leading projects through the design and also being the primary technical contact (both internally and externally) through manufacturing, assembly, debug, final acceptance, and service of engineered-to-order machinery.

Key Responsibilities :

  • Concept Develop / Design to Standards : Concept and layout technical solutions using company standards and/or new technology. Compiles and analyzes operational, test and research data to establish performance standards for newly designed or modified machines. Prepare machine layout and detailed drawings.
  • Deliver Project Scope/Schedule/Budget : Control project costs through efficient design practices.
  • Documentation : Maintain all technical documentation for assigned projects including but not limited to Functional Specifications, Flow Diagrams,Floorplans, Utility Requirements
  • Lead Design Teams : Project lead technical contact providing project support through manufacturing, assembly and debug and final acceptance. Mentor Engineer l and new engineering staff.
  • Technical Expert/Support : Keep abreast of new applicable technologies. Provide Service support for past projects. Support internal and customer design reviews.
  • Implement Product Standards : Maintain engineering standards.

Education/Experience/Skills/Abilities:

  • BSEE or equivalent or 2 year AA degree with 10+ years of automated machine design experience.
  • 5+ years of automated machine design experience with BMSE or 10+ years of automated machine design experience with 2year AA degree (packaging industry preferred).
  • Proficient in Solid Works.
  • Thorough understanding of machine design including Mechanisms, Pneumatics, Control devices, Manufacturing practices.
  • Proven problem solving skills.
  • Excellent communication skills, written and oral.
  • Effective interpersonal skills working with-in a team environment.
  • Strong planning and prioritization skills including the ability to work with limited supervision.

Physical Demands/Working Conditions :

  • Some travel may be required (less than 20% expected average).
  • Typical office environment, but frequently works in a manufacturing environment with exposure to moving mechanical parts and moderate noise level.



Posted: January 6, 2017, 7:04 am
Category : Electrical Engineer
Job Type : Permanent
Id : 6829
Region : Twin Cities

Job Responsibilities:  

  • Hardware Design:  The Project Engineer Hardware Design Engineer is responsible for development of designs that will be delivered
  • to the CAD department for CAD drawing development and in turn the drawings will be sent to customers for review and to our production department for build.
  • Communications with Engineering, CAD, Production, and Administration teams
  • Attending Hardware Design Team, CAD Team, and Engineering Department meetings
  • Project engineering – Hardware Design:   Industrial control panel design UL508A 2.2 3-phase (less than 600V), single phase, and low voltage power distribution 2.3 HMI/PLC Control systems designs, including plant-wide SCADA systems 2.4 Industrial networks designs 2.5 Industrial electrical safety designs and compliance 2.6 Short Circuit Current Rating (SCCR) Calculations 2.7 Hazardous Area panel designs (occasional) 2.8 Code compliance 2.8.1 Industrial control panel design UL508A, UL698 (required) 2.8.2 National Electric Code (NEC/NFPA70) (required) 2.8.3 Occasional:  2.8.3.1 Electrical Standard for Industrial Machinery (NFPA 79) 2.8.3.2 Electrical Safe Work Practices (NFPA70E) 2.8.3.3 European Community (EC), CE Compliance and IEC 60204 
  • Control system equipment specification
  • Understanding of components required in controls systems designs
  • Vendor meetings
  • Vendor negotiations (occasional for equipment evaluation)
  • Job management/parts database software– develop proficiency 
  • Mentoring less experienced employees
  • Review of CAD Drawings 
  • Design and shop assembly manufacturing process support for optimal efficiency and quality
  • Customer interface and support
  • Assist engineers from other departments in hardware designs and production coordination 3.0 Project Management
  • The Project Engineer has primary project management responsibility for a number of projects.  
  • The Project Engineer is responsible for project execution within the constraints of scope, schedule, and budget
  • The Project Engineer will perform project work to accomplish the project objectives
  • The Project Engineer shall also participate in sales/marketing activities including: Customer visits with potential and existing customers.  Proactive business generation
  • Quote generation/estimating
  • Follow-up with customers
  • Production Coordination
  • Project Management for Control Panel Builds
  • Procurement – occasional backup to production manager
  • Validate parts in manufacturing software 4.0 PLC and HMI Programming and commissioning (rarely required)
  • Up to 15% travel to industrial manufacturing facilities.  Typical locations are in North America.  Rarely travel to other continents.  Overnight travel from a few days to several days at a time.  Travel duration rarely exceeds 12 days in a row.
  • Construction Area site work around construction equipment and personnel.
  • Electrical/Instrumentation Device Checkout and Troubleshooting. Includes voltage testing, equipment troubleshooting on a ladder, and light electrical assembly – signal wiring in control panels/instruments. Working and interfacing with operations, engineering, equipment supply, and construction personnel. Typical Personnel Protective Equipment (PPE) Required:  Safety Glasses, Steel Toed shoes, hearing protection, and electrical safety PPE
  • Employees must comply with customer specific safety requirements and PPE
  • Work may include working weekends, holidays, nightshift, and extended hours to meet deadlines and commissioning requirements.  At times site work can be 12+ hours/day.

Minimum Qualifications:

  • Bachelor of Science Degree

 

Posted: December 7, 2016, 11:23 am
Category : Electrical Engineer
Job Type : Permanent
Id : 6796
Region : Twin Cities

This key role is responsible for the creation of controls/ electrical design and programs that meet the technical, project cost, and schedule criteria of projects. Leading projects through the design and also being the primary technical contact (both internally and externally) through manufacturing, assembly, debug, final acceptance, and service.

 

Key Responsibilities:

  • Concept Dev/Des to Standards: Develops and maintains standards in design of control systems for new models and modules. Develops the controls, electrical and pneumatic systems for assigned projects. Develops efficient software programs for assigned projects.
  • Deliver Project Scope/Schedule/Budget: Attend, support and document Concept and Design Reviews.
  • Lead/Mentor Design Teams: Project lead technical contact providing project support through manufacturing, assembly, and debug and final acceptance. Programming support throughout the assembly debug process.
  • Technical Expert/Support: Keep abreast of new applicable technologies. Provide Service support for past projects. Support internal and customer design reviews. 
  • Implement Product Standards Maintain engineering standards. 
  • Documentation: Maintain all technical documentation for assigned projects including but not limited to Functional Specifications, schematics, programs,... 
  • Provide support for Customer FAT activities.
  • Sales support: Technical consultation, review of customer specifications.
  • Analyzes designs to increase safety, effectiveness and efficiency and reduce costs.
  • Support and promote the Company's values through day-to-day words, actions and gestures.

 

Experience, Skills and Education:

  • BSEE with 3+ years or AA with 5+ years of commensurate experience
  • Proficient in electrical design software, AutoCAD Electrical preferred. 
  • High speed, 200+ppm, intermittent and continuous motion machinery
  • PLC and computer programming and interfaces
  • Servo/Stepper motor control and associated software
  • Barcode, vision, check weighing and laser systems
  • Machine robotics
  • Pneumatic and vacuum circuits
  • Schematics and machine wiring
  • Proven problem solving skills
  • Excellent communication skills, written and oral
  • Effective interpersonal skills working with-in a team environment
  • Strong planning and prioritization skills including the ability to work with limited supervision

 

Work Environment/ Physical Requirements:

  • Some travel may be required (less than 20% expected average).
  • Typically works in an office environment, but will need to visit various production facilities.
  • Standard 40 hour week, but may vary depending on project requirements.


Posted: October 13, 2016, 7:41 am