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Development Resource Group

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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 : Software Engineer
Job Type : Contract
Id : 7014
Region : Twin Cities

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

The primary focus will be on leading and facilitating the Quality and Reliability activities while collaborating with the product design and development teams. This position will also play a critical role in defining and expanding software reliability expertise within the Company.

The Software Engineer will be expected to serve as both a technical leader and a change agent, working collaboratively with multiple business functions.  As such, this role is expected to have a mastery of reliability engineering standards, technical principals, theories, concepts and tools, effective communication skills that serve a broad range of audiences (both technical and non-technical), and the leadership skills needed to be recognized as a subject matter expert and primary technical contact for reliability on projects and/or programs.

 

POSITION RESPONSIBILITIES:

  • Top responsibility is for the quality of Company products which support the monitoring and follow up of patients with implanted cardiac devices.
  • Understand 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: July 14, 2017, 12:44 pm
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-to-Hire
Id : 7010
Region : Twin Cities

Seeking a Senior Mechanical Design Engineer to design for manufacture and ownership of mechanical hardware design and layout for Medical Device manufacturing.  Also, hardware design improvements for next generation products, development and updating of requirements and engineering specifications. Troubleshooting including: chassis, mechanical actuation, specifying parts and tolerances.  

 

Required Experience:

  • Bachelor's Degree in Mechanical Engineering
  • Proficient in SolidWorks
  • 5+ year's industry experience in actuation, optics implementation, quality documentation
  • Experience in understanding machining requirements and limitations
  • Familiarity with Class 2 IVD products
  • Candidates must be highly self-motivated and a life-long learner


Posted: July 12, 2017, 6:33 am
Category : Technicians
Job Type : Contract
Id : 7009
Region : Twin Cities

Looking for a Senior Quality Engineering Technician to be responsible for the Supply Chain Quality Component Engineering technician activities for implantable products (raw material, parts, sub-assemblies and assemblies) related to new product design. This includes technical inspection/testing for prototype and production components from suppliers and assisting department Supply Chain Quality Engineers with documentation in support of their development projects.

 

POSITION RESPONSIBILITIES:

  • Provide Supplier Quality Engineering technician support to product development programs responsible for new medical device products
  • Development and documentation of inspection/test methods here and at supplier facilities.
  • Measurement gage and fixture design.
  • Provide technical inspection and testing of prototype and production components as received from suppliers using: Basic measurement hand gages (e.g. micrometer, caliper, indicator, height gage), Manual optical devices (e.g. microscope, optical comparator),  Computer assisted optical devices (e.g. tool maker's microscope).
  • Determination of component compliance to specification or drawing, including analysis of collected data.
  • Completion of Test Method Validation / Measurement Systems Analysis (Gage R&R and correlation) at suppliers and/or contract inspection services. 
  • Interface with Company inspection, technical, and engineering employees for the development and review of qualification and inspection processes and procedures.
  • Assist department engineers with completing project deliverables.
  • Participate in internal and supplier audits.
  • Provide technical expertise during supplier evaluation and selection.
  • Travel as required to support assigned projects or other application work requirements. Typically < 25%.

 

BASIC QUALIFICATIONS:              

  • Technical school graduate
  • 5+ years of experience in quality, manufacturing, or other related engineering field
  • Understanding of quality principles, procedures, methodologies, and basic statistics.
  • Experience interpreting engineering drawings, including Geometric Dimensioning and Tolerancing (GD&T).

 

PREFERRED QUALIFICATIONS:

  • Experience in a quality engineering technician support role in a manufacturing factory environment of metal forming, plastic forming/extrusion, chemical processing, foundry or wire coating.
  • Experience in inspection and testing of components using: Advanced measurement gages (laser micrometer, surface profilometer), Programmed multipurpose measurement equipment (vision CMM, touch-probe CMM, multi-probe CMM), Programmed application specific measurement equipment (roundness tester, white light interferometry).
  • Proficient programming ability in PC-DMIS.
  • Ability to use CAD or PRO-E files to create CMM programs.
  • Experience with data analysis software applications such as MiniTab or equivalent.
  • ASQ Certified Quality Technician.
  • Knowledge, understanding and implementation experience with medical device quality systems, manufacturing operations, supplier quality, and regulatory requirements. 
  • Demonstrated high proficiency with word-processor, spreadsheet, and database software.
  • Good communication, interpersonal and technical writing skills.


Posted: July 11, 2017, 9:19 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 : Contract
Id : 7007
Region : Twin Cities

 

Looking for motivated, highly accountable, and results-oriented Manufacturing Engineer to develop manufacturing processes for implantable medical components.

 

Job Requirements:

  • Must have good mechanical aptitude and experience in designing production tooling and fixturing; experience with drafting software itself not required.
  • Specific deliverables include tool inspection reports, environmental health & safety assessments, process characterization, test method validation, pFMEA, IQ, OQ, PQ
  • Must have excellent oral and written communication skills
  • Prior experience with ceramics, furnace applications, vacuum systems or physical deposition would be beneficial but not required
  • Experience generating high-quality documentation for FDA-regulated industry (TUV/FDA experience)
  • Bachelors degree and 3-5 years' experience in Medical Device required


Posted: July 11, 2017, 6:55 am
Category : Industrial Engineer
Job Type : Contract
Id : 7006
Region : Twin Cities

Looking for a Senior Industrial Controls Engineer to design, deliver, and support equipment solutions for a wide range of innovative medical electronics-based products and process control equipment. This candidate will be responsible for the development and release of equipment solutions supporting the release of new product manufacturing lines.This engineer would also be involved in determining if existing equipment is adequate to support production manufacturing requirements for new products. This engineer would be responsible for designing and implementing both the software and the hardware portion of the equipment solution.

POSITION RESPONSIBILITIES: 

  • Developing software applications using Automated Equipment to manufacture or test electronic components utilizing software languages and environments preferably in PLC Ladder Logic and/or structured text and CAD to perform application software development and electronics design 
  • Designing, developing, and debugging dedicated hardware and software, performing verification and validation activities, performing Measurement Systems Analysis (Gage R&R studies); all in support of equipment solution release for production manufacturing of electronic medical device 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
  • 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
  • Responsible for department budget as related to Annual Operating Plan targets. 
  • Develops electromechanical technical solutions to complex problems that require the regular use of ingenuity and creativity 
  • Lead and foster a culture of driving toward high quality designs, collaboration, and innovation 
  • Mentors and serves as a both a people and technical leader 
  • 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 

 

EDUCATION/EXPERIENCE REQUIRED: 

  • Bachelors in Electrical Engineering, Controls Engineering, Industrial Engineering, Computer Engineering or related Engineering discipline 
  • 5+ years of experience in Engineering Design and Development with Bachelors  OR 3+ years of experience in Engineering Design and Development with an Advanced degree 

 

SPECIALIZED KNOWLEDGE REQUIRED: 

  • Familiar with PLC Ladder Logic, Structured text, Industrial Controls Software, HMI 
  • 3+ years of experience working in a medical or other regulated industry 
  • Strong communication, manufacturing process, product industrialization and leadership skills 
  • Solid design, troubleshooting and presentation skills

 

Posted: July 10, 2017, 12:29 pm
Category : Quality Engineer - Medical Device
Job Type : Permanent
Id : 7004
Region : Wisconsin

Seeking a Quality Engineer with Medical Device Background to perform the following duties:

 

Job Responsibilities:

  • Be a technical resource for the initiation and implementation of cost improvement plans on new and existing programs
  • Lead development and review of validation plans and protocols
  • Measure validation process effectiveness and lead continual improvement of system
  • Communicate and coordinate activities including internal and external approvals of validations
  • Coordinate new process techniques that improve overall job efficiencies
  • Implement systems and procedures that assure compliance with Quality Standards
  • Development and implementation of statistical incoming and in-process sampling/control plans
  • Manage the qualification of processes performed by PPC suppliers; troubleshoot and lead corrective actions relating to supplier performance; improve process for supplier data submission to reduce internal inspections
  • Participate in AQP meetings representing quality, where appropriate
  • Provide engineering team with information and analysis tools as needed
  • Facilitate communication between engineering function, manufacturing, and quality
  • Responsible for being a communication liaison between the customer and manufacturing facility
  • Extended travel to other facilities may be required to support business needs
  • Some programs may have vision requirements

 

Required Experience:

  • Bachelor degree in an engineering discipline or equivalent combination of education and experience,
  • Minimum six (6) years quality/regulatory experience
  • Minimum Three (3) years auditing experience

 

Required Skills:

  • Understanding of the project development process, associated terminology, and quality system requirements
  • Ability to effectively present information and respond to questions from group of managers, sales, and customers
  • Strong communication (verbal and written), teamwork and organizational skills
  • Ability to identify problems, and develop and implement actions to resolve them
  • Ability to motivate and influence people to achieve customer satisfaction
  • Demonstrable track record of project accomplishment
  • Demonstrable track record of planning activities with contingency actions

 

Posted: July 10, 2017, 10:03 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 : Permanent
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-to-Hire
Id : 7002
Region : Twin Cities

Seeking a Manufacturing Support Technician to accurately enter and monitor SPC data and perform sample prepping for inspection of machined components. To perform audits of SPC data entered by Machinists and Inspectors. To support the Inspection Department by performing inspection of incoming material, sorting and assisting with inspection method improvement.

 

Qualifications:

  • High School education or equivalent.
  • At least 3 years of related experience.
  • Strong mechanical aptitude, troubleshooting and problem solving skills.
  • Ability to interpret mechanical drawings.
  • Skilled in the use of basic mechanical inspection tools.
  • General understanding of basic Lean Manufacturing principles.
  • General Understanding of statistical process control (preferred).
  • Ability to travel as needed.
  • Ability to work well and communicate with others.


Posted: July 5, 2017, 12:09 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 : Firmware Engineer
Job Type : Permanent
Id : 6997
Region : Twin Cities

Great opportunity for an Embedded Software Engineer to join our software team.  Individual would be responsible for the successful design, implementation and validation of embedded software targeting customs hardware designs.

 

Core Responsibilities:

  • Design and implement embedded software for various sensor projects
  • Design and implement unit tests and stress tests for validation of embedded software
  • Document software design and communications interfaces.
  • Design and implement engineering programs to aid in testing and manufacturing of sensors
  • Work with manufacturing and development resources to ensure success of sensor build, calibration, test and integration
  • Provide support for legacy sensors, designing and implementing solutions to challenges found in the field
  • Participate in software process improvement team

Experience, Education and Competencies Required:

  • BS Degree in Computer Science or Electrical Engineering (or similar)
  • 3+ years developing applications on custom electronic hardware
  • Proficiency in C and C++ programming on embedded systems
  • Strong electrical background and proficiency in reading electronic schematics, component datasheets, and utilizing electronics troubleshooting tools including logic and protocol analyzers, oscilloscopes, etc.
  • Working with multi-discipline engineering teams throughout all phases of development


Posted: July 3, 2017, 10:09 am
Category : Manufacturing Engineer
Job Type : Contract
Id : 6998
Region : Twin Cities

Seeking a Manufacturing 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.

 

Desired/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 : Quality/Regulatory
Job Type : Contract
Id : 6996
Region : Twin Cities

Seeking a Supplier Quality Engineer to be responsible for supporting and implementing Supplier Own Quality (SOQ) activities for Company suppliers. SOQ is an initiative to link Supplier's Quality data to Company's Receiving Inspection department thus eliminating the need for components inspection. Additionally, the position will help drive Supplier Management Strategy and Quality System improvements. 

POSITION RESPONSIBILITIES: 

  • Coordinate the review of Supplier Quality metrics. Ensure metrics are collected and entered in metric collection databases. Create presentations on data from Supplier Quality 
  • Collaborate with Company representatives to harmonize on appropriate supplier controls. 
  • Contributes to the implementation of updated Corporate Policies and Corporate SOPs to ensure compliance
  • Conduct Supplier Audits. Work with Supplier Quality Engineers to close out any audit findings 
  • Support Approved Supplier List Maintenance
  • Support Company CAPA initiatives
  • Contributes to supplier risk reduction projects
  • Streamline and improve department procedures to ensure quality and compliance 
  • Provide investigational support on Supplier Quality activities and develop solutions 
  • Review and approve supplier documentation
  • Participate in Operations & Sourcing Functional Data Source Review activities 
  • Coordinate with other Business Units on best practices for supplier management 
  • Lead improvement projects within Supply Chain Quality 
  • Support external agency audits of the Supply Chain Quality Organization
  • Respond to audit findings with effective preventive and corrective actions 
  • Support special projects as needed 

 

BASIC QUALIFICATIONS: 

  • Bachelor's Degree with 0-2 years of experience in quality, manufacturing or operations 

 

DESIRED QUALIFICATIONS: 

  • Understanding of quality principles, procedures, methodologies, and basic statistics 
  • Knowledge of regulatory environments (i.e.: ISO, FDA-GMP, etc.) 
  • Experience working in a team environment
  • Ability to communicate effectively (written and verbal) across all levels and across businesses 
  • SCAPA/CAPA documentation systems experience
  • Knowledge of all aspects of medical device operations (quality, manufacturing, supply change, design) 
  • Solid judgment and problem solving skills
  • Ability to manage multiple projects or priorities 
  • Strong influence and negotiation skills 
  • Knowledge of statistical analysis techniques 
  • Knowledge of DMAIC problem solving methodology 
  • Project Management experience


Posted: June 29, 2017, 11:34 am
Category : Project Manager
Job Type : Contract
Id : 6994
Region : Twin Cities

Job Description:

  • Partner with individuals and team to drive accurate and timely support to other teams as required. 
  • Seek and analyze information from all sources to understand the project scope and what activities need to be accomplished (including who, how, duration, effort). 
  • Facilitate maintenance of remediation documents (review and approval of plans/closure reports, schedules, metrics/execution tracking, visual management, etc.). Partner with team to execute and monitor the project (includes some elements of task management, tracking, and expediting). 
  • Create and maintain course summaries for new and existing training courses. 
  • Facilitate and monitor (including tracking and expediting) approval of documents through document management system as requested. 
  • Oversee maintenance and improvements for Sitebuilder sites used within the organization. 
  • Maintain and continuously improve the project management process, tools / templates, best practices, and overall implementation
  • Seek out and engage regularly with peers, creating an environment of exchange and learning. Openly share successes, challenges, and failures to promote the team's collective learning and overall improvement
  • Maintain high level of business etiquette and effective working relationships with co-workers and individuals from other functions. 
  • Ensure personal understanding of all quality policy/system items that are applicable to perform job responsibilities. Follow all work/quality procedures to ensure quality system compliance and high quality work. 

 

Requirements: 

  • Bachelor's degree with 2+ years of experience in Project Management
  • Microsoft Project, Excel

 

Desirable Requirements: 

  • Experience leading projects or subprojects, direct support of product development 
  • Experience in a regulated industry 
  • Electronic meeting/calendar coordination 
  • Strong communication skills – verbal and written 
  • Attention to detail and ability to pull information from many different systems together quickly for report and presentations 
  • Ability to work well under pressure in a dynamic environment 
  • Strong organizational skills 
  • Previous project coordination experience 
  • Ability to exercise independent judgment and discretion 
  • Sitebuilder experience 
  • Knowledge of medical and audit terminology


Posted: June 29, 2017, 7:10 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 : Technicians
Job Type : Contract
Id : 6993
Region : Twin Cities

Seeking a Technician to work under direct supervision to clean, repair or test physician programmers, electrical screener devices, and other hand held medical devices/accessories. Utilize oscilloscope and multimeter to perform testing on devices. Keep accurate records of work performed. Provide weekly status report on work performed.  Must have a willingness to learn and follow directions.  Soldering experience a plus.

 

Requirement:

  • Two year technical degree, preferably electronics but will consider others


Posted: June 28, 2017, 7:59 am
Category : Electrical Engineer
Job Type : Contract
Id : 6991
Region : Twin Cities

Seeking a Controls Engineer to be part of a software development team implementing and testing a complex control system for wind tunnel research.  Responsible for maintaining and modification of HMI screens, maintaining HMI tag database, VBA scripting of screen objects and global procedures, historical database maintenance and manipulation, data exchanges between other data devices including, but not limited to, PLCs and other 3rd party PCs.

 

Required Skills:

  • Experience developing, testing, documenting, and commissioning automation & SCADA systems using PLCs.
  • Ability to travel to job site for acceptance testing and commissioning.
  • Knowledge of Cimplicity (version 8.2)  or other HMIs with strong VB skills essential (scripting is done via VBA)
  • Previous experience using HMI historians (project uses Proficy Historian 4.5).
  • Solid knowledge in using MS Excel.
  • Understanding of OPC objects.
  • Basic knowledge of PLC/HMI interfacing.
  • Able to program in ladder logic and structured text.

 

Preferred Skills:

  • Producing and consuming EGD (Ethernet Global Data).
  • Knowledge of data buffering devices.
  • Knowledge of KEPWare.
  • Experience with Proficy Machine Edition.
  • A high aptitude for math.


Posted: June 27, 2017, 6:12 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 : Manufacturing Engineer
Job Type : Contract
Id : 6989
Region : Twin Cities

Seeking a Manufacturing Engineer to support the manufacture of products to ensure company standards are successfully achieved. This candidate will provide technical leadership and support of manufacturing improvements and floor support for assigned product lines.

 

Job Responsibilities:

  • Provides engineering support for troubleshooting efforts for any process issues in designated area.
  • Summarize and draw conclusions from test results leading to effective technical resolution of process problems.
  • Develops and maintains the documentation necessary to ensure the consistent manufacture of company products (processes, drawings, and shop floor paperwork).
  • Works with Process Development engineers to ensure design for manufacturing elements are incorporated into PDP activities.
  • Identifies, justifies, and implements significant data driven projects to reduce manufacturing costs, improve processes, increase product reliability, and enhance process capability.
  • Designs and evaluates new and existing fixtures and equipment, test methods, specifications, layouts, and standards supporting a Lean manufacturing environment.
  • Identify and recommend manufacturing technologies to strategically develop business objectives and potential opportunities.
  • May have supervisory responsibility for technician staff.
  • Comply with applicable FDA and international regulatory laws/standards and the company standards.

 

Requirements:

  • Bachelor of Science in Manufacturing or related field
  • 2-5 years Manufacturing experience


Posted: June 23, 2017, 1:11 pm
Category : Software Engineer
Job Type : Contract
Id : 6975
Region : Twin Cities

Seeking a Principal Software Engineer to provide technical leadership for Medical Device Software Product Development projects. As a Principal Software Engineer, you will be responsible for identification of all changes being introduced into the Customer Facing system including IT components (enterprise applications), performing impact analysis of each change in the system, identifying and coordinating adequate testing for each change to ensure superior customer experience with any change that is introduced into the Customer Facing system. You will also partner with colleagues and other stakeholders including engineers, testers, users, and management to ensure all aspects of the application are successful. As a technical leader, you will ensure all changes to the Customer Facing system are understood and that tests are identified that will adequately test the system to ensure there will be no adverse impact to the customer as a result of the changes implemented.

 

POSITION RESPONSIBILITIES:

  • Apply a change management process and tools to create a plan to support adoption of the changes required by a project or initiative
  • Develop process and form that each project/change request must complete that will help determine the level of System End to End testing that is recommended for the change
  • Support the design, development, delivery and management of communications
  • Conduct impact analyses, assess change readiness and identify key stakeholders
  • Ensure that all impacted workflows, test cases, and requirements have been identified for a change request
  • Ensure end to end system is documented accurately
  • Ensure that master test data has been defined
  • Ensure that system documentation is created and updated for new and existing workflows
  • Define risk profile for system interfaces and system components and identify, analyze and prepare risk mitigation tactics
  • Support organizational design and definition of roles and responsibilities
  • Track and report issues
  • Define and measure success metrics and monitor change progress
  • Attend weekly IT Change Board meeting to review IT system changes that could impact existing workflows
  • Identify gap in current workflows and document results
  • Identify realistic release coordination timing (monthly, quarterly)
  • Maintain master release schedule for all applications

 

DESIRED SKILLS:

  • Proven track record for cross-functional collaboration
  • Ability to simplify complexity
  • Detail oriented with the ability to manage a software release schedule
  • Drive for outcomes and results while staying aligned with the big picture
  • Exceptional communication skills, both written and verbal
  • Excellent active listening skills
  • Ability to clearly articulate messages to a variety of audiences
  • Ability to establish and maintain strong relationships
  • Ability to influence others and move toward a common vision or goal
  • Flexible and adaptable; able to work in ambiguous situations
  • Problem solving and root cause identification skills
  • Ability to work effectively at all levels in an organization
  • Must be a team player and able to work collaboratively with and through others

 

BASIC QUALIFICATIONS:

  • Bachelors of Science Degree in Computer Engineering or related engineering field and 7+ years of experience
  • 2+ years of experience of working in an IT organization

 

DESIRED/PREFERRED QUALIFICATIONS:

  • 9+ years in a software focused roles, especially enterprise application systems
  • Technical leadership background with a track record of leading within a large complex organization.
  • 3+ years in the medical device industry (regulated)
  • Experience working with a Customer Facing system


Posted: June 16, 2017, 12:23 pm
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 : Software Engineer
Job Type : Contract
Id : 6955
Region : Twin Cities

Seeking an Embedded Software Engineer with solid RTOS experience (ThreadX, microC/OS, RTLinux, VxWorks, etc.) and security experience implementing SSL/TLS protocols on an RTOS.

Able to add SSL/TLS technology to embedded operating system in order to secure email communications from devices to an email server.

 




Posted: June 6, 2017, 9:32 am
Category : Technician - General
Job Type : Permanent
Id : 6954
Region : Twin Cities

Seeking a Field Service Technician to assist the packaging service department with sales/applications support, applications and service related procedure development, training customers or distributors on the packaging equipment, technical phone support, field service, equipment install and repairs on all packaging equipment.

KEY RESPONSIBILITIES:

Service Support:

  • Establish and maintain a good business relationship with present and potential customers. Represent the department and the company in a professional, businesslike manner.
  • Provide applications support for equipment sales proposals.
  • Provide technical phone support to customers including extended hours of support.
  • Conduct field service and installation work.
  • Perform in-house repairs along with associated transactions and documentation.
  • Provide training to direct customers and distributors.

Miscellaneous:

  • Monitor and report field issues. Develop and communicate recommendations for changes in products, procedures and policies to reduce field issues, control costs and improve customer satisfaction. Coordinate and communicate with Engineering, Assembly, Accounting, Customer Service, Sales and other departments as needed.
  • Develop service-related training materials for distributor and customer sales staff and service personnel.
  • Assist with and conduct training.
  • Ensure the accurate and timely reporting of installation and repair expenses.
  • Coordinate with Sales and Accounting departments to ensure accurate customer billing.

JOB QUALIFICATIONS:

  • Associates degree in a technical specialty or equivalent work experience.
  • Minimum of 5-7 years experience in servicing electro-mechanical equipment or equivalent.
  • Intermediate/advanced understanding of electrical schematics and PLC's.
  • Strong electro-mechanical aptitude and related troubleshooting skills. Able to interpret and evaluate information and create analytical approaches to achieve results.
  • Ability to provide exceptional customer service.
  • Excellent written and verbal communication skills.
  • Ability to handle multiple tasks and manage time effectively.
  • Ability to work independently.
  • Strong personal standards of excellence, ethics and integrity; ability to maintain sensitive and confidential information.
  • Good knowledge of Microsoft Outlook, Word and Excel.
  • Must have a valid Class D driver's license.
  • Ability to travel 50-60% of the time.

Desired Requirements:

  • Associates degree in technical specialty.
  • Previous experience servicing packaging machinery.
  • Previous training experience


Posted: May 11, 2017, 8:08 am
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 : Systems Engineer
Job Type : Permanent
Id : 6939
Region : Twin Cities

The Principal Systems Engineer will be primarily responsible for design, development and maintenance of R&D systems. This position also involves helping senior management with planning, budgeting and strategy discussions as it relates to systems development and maintenance.   This position will be the technical lead for new forward looking pipeline projects and innovation initiatives within the R&D team. 

 

PRINCIPAL RESPONSIBILITES

  • Develop and maintain adequate documentation for required regulatory approvals of the system. This includes but not limited to requirements, design documents, test plans and protocols, test reports, verification and validation reports, risk analysis, hazard analysis, FMEA, certification tests.
  • Responsible for modeling advanced system concepts and helping functional leads understand risks and possible mitigations for novel designs.
  • Responsible for coordinating activities within R&D group and collecting input from functional leads to create system level plans and budgets.
  • Help with vendor selection for production of new systems and interface with operations for design transfers.
  • Help with IP management and interface with outside attorneys in patent creation and addressing issues with pending patents.
  • Provide input into technology options and help with systems strategic planning activities.
  • Hands on activity within the R&D team to support product development efforts.
  • Lead technical efforts in innovation and early pipeline activities.
  • Interface with physicians and develop requirements for products in coordination with marketing teams
  • Help develop strategy for animal testing and be the primary R&D representative for all pre-clinical testing
  • Monitor evolution of external regulations and standards to ensure products meet appropriate requirements
  • Mentor junior engineers and be a technical resource for cross functional teams to educate them on technical details
  • Ensures that all activities and interactions are carried out with the highest ethical and professional standards.

 

EDUCATION AND EXPERIENCE

  • Minimum of Bachelor's Degree in electrical engineering, mechanical engineering, or related engineering discipline.  Advanced degrees in aforementioned disciplines preferred.
  • Minimum of 8+ years of experience in medical device engineering with 4+ years as a systems engineer.

 

SKILLS AND ATTRIBUTES

  • Expertise in electrical, mechanical and software engineering with aptitude to identify and solve cross functional challenges.
  • Expertise in medical device regulations and certification requirements for CE mark, IDE, 510(k) and PMA approval.
  • Proficient in understanding the workings of electro mechanical systems
  • Has technical knowledge and understanding of engineering design principals
  • Understands and is able to adapt to the rigors of a regulated industry
  • Ability to communicate effectively with cross functional team as well as customers and key project stakeholders


Posted: April 25, 2017, 1:16 pm
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 : Technicians
Job Type : Contract
Id : 6928
Region : Twin Cities

Seeking a Manufacturing Technician to be responsible for performing installation of hardware, hardware diagnostics, maintenance, and repairs, including multi-vendor maintenance with customer satisfaction and asset management as additional areas of responsibility. This position requires customer interaction while performing repairs, installations, etc. Requires ability to work nights, weekends, overtime, flex shifts, and on-call times. Requires excellent interpersonal and relationship skills, and an innovative approach to problem-solving. A commitment to quality and customer service also required. Loading and unloading of parts, tools and equipment required. Bending, stooping, walking, and lifting in excess of 25 pounds required.

 

Additional Requirements: 

  • 1-2 years of Manufacturing experience 
  • Quick learner 
  • Take on preventative maintenance tasks and execute in a timely manner 
  • Hard worker 
  • Able to perform basic troubleshooting 
  • Has long term potential 
  • Will need to manage multiple issues and prioritize quickly 

 

Education:

  • Diploma, 2 year or 4 year degree
  • Associates degree in electronics or computer technology is preferred 



Posted: April 6, 2017, 7:30 am
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
Category : Electrical Engineer
Job Type : Contract
Id : 6791
Region : Twin Cities

 

Machine Vision Software Engineer- Electrical Engineer / Software Engineer needed to develop and support existing machine vision inspection systems and custom automated control systems used in the development and production of medical devices. Will work within equipment/software engineering group to design machine vision systems, including concept, plans, programming, and troubleshooting for complex manufacturing and test equipment.

 

Requires BS (CS or EE) and prefer 1 to 3 years of experience with automated equipment development, including some hands-on vision system knowledge. Prefer experience with .NET and C++ programming, Allen Bradley PLC's and understanding of automated equipment design. Prefer experience with Cognex Vision system development. Exposure to robotic systems a plus.

 

Job Responsibilities:

  • Investigate machine vision software to identify opportunities to increase yields and/or quality of the vision system.
  • Determine root cause with regard to machine vision inspection issues.
  • Update machine vision software for enhancements and bug fixes of existing systems.
  • Investigate machine vision lighting solutions to enhance existing inspection systems.
  • Collect and analyze inspection results to prove robustness of vision system changes.
  • Integrate machine vision system into a PC or PLC based system.
  • Troubleshoot machine vision and controls systems using pneumatic and electrical schematics.
  • Develop/Update departmental standards.
  • Create supporting design documentation.
  • Make software and hardware modifications to existing automated controls equipment.
  • Follow departmental procedures and processes when updating and developing new systems.
  • Participate on project teams to develop clear specifications, evaluate feasibility of concepts, and provide estimates for electrical/software designs.
  • Communicate costs and project status to project lead.
  • Creates electrical/software designs utilizing the departments' standard development tools and procedures.


Posted: October 5, 2016, 12:05 pm