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Development Resource Group

Get updates on all the job openings from Development Resource Group.

Category : Quality/Regulatory
Job Type : Permanent
Id : 7472
Region : Twin Cities

Looking for a responsible and highly motivated Quality Lead Inspector with strong leadership and coaching skills. The Ideal Candidate must have a minimum 5 years QA experience and a working knowledge of production machining. This person must be tech-savvy and possess strong written and verbal communication skills. Be able to train and demonstrate inspection techniques to others.  Understanding of outside vendor processes such as plating and heat treat preferred.  Knowledge of JobBoss and uniPoint software a PLUS.

 

Job Highlights to include, but not limited to:

  • Perform and document first article and set-up inspections.
  • Strong Blueprint and GD&T knowledge.
  • Ability to perform and document PPAP reports.
  • Complete written quality audits.
  • Understand and document the Corrective Action Process.
  • Assist in Root cause investigation and preventative actions.

 

Additional Qualifications:

  • Knowledge of all inspection tools and when to apply them, such as micrometers, pin gauges, calipers, thread gauges and vision systems.
  • Solid computer skills including Microsoft Office applications
  • Advanced print reading experience.
  • Understanding of Geometric Dimensioning and Tolerancing
  • Excellent written and oral communication.
  • Demonstrated ability to work efficiently under conditions of multiple deadlines and changing priorities.
  • Detailed documentation skills.
  • Problem solving and critical thinking skills, self-motivated, self-directed individual.
  • Experience working in a fast-paced, dynamic and multi-cultural environment.


Posted: August 16, 2018, 12:42 pm
Category : Electrical Assembler
Job Type : Contract-to-Hire
Id : 7471
Region : Twin Cities

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

RESPONSIBILITIES:

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

REQUIRED:

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

DESIRED:

  • Knowledge of UL508A standards


Posted: August 15, 2018, 11:21 am
Category : R&D Engineer
Job Type : Contract
Id : 7470
Region : Twin Cities

Seeking a R&D Engineer to support the development of Medical Device systems. This position works in collaboration with a global team tasked with development and verification of the chemical sorbent component of the system. A majority of the time will be spent in laboratory preparing and testing sorbent materials and functional sorbent sub-components. This position works independently with limited supervision and direction.

Position Responsibilities:

  • Use engineering principles to assist in the design and testing of a chemical sorbent cartridge used with Medical Device Systems
  • Plan and conduct experiments to characterize the sorbent cartridge and associated components. Develop and optimize chemical processes and associated test methods as needed.
  • Conduct preclinical studies using functional prototypes to assess performance and identify potential issues.
  • Set-up and operate testing equipment including data acquisition software; perform calibration and test method characterization as needed.
  • Collect and prepare samples for analysis; perform sample analyses using established procedures.
  • Analyze results, document findings and present to project team for review.
  • Write and review reports of experimental procedures and results in compliance with quality system and regulatory requirements
  • Monitor and maintain laboratory supplies; partner with other scientists and engineers to maintain safe and efficient labs in compliance with established policies.

Must Have Skills and Experience:

  • Bachelor's Degree in Chemical or Biomedical Engineering required plus 3+ years of demonstrated experience
  • Working knowledge of packed bed chemical reactor design and characterization
  • Proficiency operating common laboratory equipment such as balance, pH meter, conductivity meters, etc., and associated software
  • Experience working in a regulated product development environment
  • Demonstrated experience in the safe handling of chemicals and biologic materials
  • Proficiency with Microsoft Windows and Microsoft Office software.
  • Strong communication skills [oral, written, and/or presentation] including listening; and ability to maintain clear project status and interlocks with internal project teams and external test agencies

Highly Desired Skills and Experience:

  • MS or PhD in Chemistry, Chemical Engineering or related field
  • 5+ years of experience in medical device R&D
  • Working knowledge of the principles of hemodialysis


Posted: August 15, 2018, 8:07 am
Category : R&D Engineer
Job Type : Contract
Id : 7469
Region : Twin Cities

Seeking a Senior R&D Test Development Engineer for the following:

Job Description:

  • Develop complex test systems to support new product development and design changes.
  • Write Plans, Protocols, and Reports to support Test Method Characterization and Validation.
  • Design and implement experiments to support proof of concept and verification activities.
  • Develop and qualify test systems software and hardware.
  • Support decisions that impact system architecture determined by thorough engineering analysis and data.
  • Develop data acquisition systems and perform mathematical and statistical analysis of captured data.
  • Develop design testing and characterization plans.
  • Document all development activities to ensure design traceability.
  • Perform troubleshooting and root cause analysis of complex electro-mechanical systems.
  • Predict test performance and potential failures, and provide required product / design input when applicable.
  • Identify issues and develop recommendations/suggestions for solutions to communicate to design engineers.

Must Have Skills and Experience:

  • Bachelor's Degree required plus 5+ years of demonstrated experience with developing complex electro-mechanical systems, test and measurement equipment, analysis methodologies and test documentation.
  • Solid understanding of engineering fundamentals and proven hands-on mechanical skills.
  • Proficiency with developing basic electronic circuits and wiring electromechanical components.
  • Proficiency in integrating data acquisition systems with load cells, accelerometers, and peripheral devices utilizing serial and Ethernet communication.
  • Proficiency in developing data acquisition and motion control applications using LabVIEW software.
  • Proficiency with standard test equipment including Instron, accelerometers, force gauges, and data loggers.
  • Demonstrated ability to perform as a contributing member of cross functional teams
  • Analytical with strong problem-solving abilities and creative resolution skills
  • Proficient in Microsoft office programs including Excel and Word
  • Ability to prioritize workload, meet multiple deadlines simultaneously in a fast-paced environment
  • Ability and willingness to learn; seek out development activities to improve skills and increase knowledge; learn from other team members and own mistakes
  • Strong communication skills [oral, written, and/or presentation] including listening; and ability to maintain clear project status and interlocks with internal project teams and external test agencies

Highly Desired Skills and Experience:

  • Familiarity with concepts of design input, design output, traceability, and risk analysis
  • Experience with Measurement Systems, Gauges and Inspection Systems, GD&T, and Gage R&R
  • Experience with statistical software and principals.


Posted: August 15, 2018, 8:01 am
Category : Quality Engineer - Medical Device
Job Type : Contract
Id : 7468
Region : Twin Cities

A Design Assurance Engineer assures new or modified products conform to quality standards and establishes compliance with the quality system. Responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success by protecting patient/user safety and meeting business needs.

Responsibilities:

  • Lead on-time completion of Design Control Deliverables
  • Create and ensure on-time execution of Quality Plans for internal development, OEM-based, Clinical Product Development (CPDP), and design change projects
  • Accountable for Design Verification and Validation planning & execution, including active cross-functional root-cause analysis investigation & resolution activities
  • Support design test and inspection method development, and lead method validation activities
  • Ensure DHF content completion, integrity, and regulatory & standards compliance; collaboratively communicating & resolving gaps
  • Support and ensure the establishment of objective, measurable, discrete, and verifiable customer and product requirements
  • Support and ensure objective component specification definitions, supplied component sampling plan development, and vendor qualifications
  • Complete Document Change Request Reviews in a timely and objective manner
  • Perform other duties and responsibilities as assigned by management.
  • Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
  • Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
  • Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
  • Performs other related duties and responsibilities, on occasion, as assigned.

Position Qualifications:

  • Bachelor level degree in Engineering or Technical Field
  • 5+ years experience
  • Previous Quality engineering experience and demonstrated use of Quality tools/methodologies
  • Solid communication and interpersonal skills
  • Project management and leadership skills, including the demonstrated ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner
  • Advanced computer skills, including report writing skills
  • Ability to work within a team and as an individual contributor in a fast-paced, changing environment
  • Strong organizational and follow-up skills, as well as attention to detail
  • Ability to maintain regular and predictable attendance
  • Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization
  • Multitasks, prioritizes and meets deadlines in timely manner

Preferred Experience:

  • Prior medical device experience
  • Experience working in a broader enterprise/cross-division business unit model
  • Ability to work in a highly matrixed and geographically diverse business environment
  • Product Lifecycle Management (PLM) systems (e.g., Windchill)



Posted: August 14, 2018, 8:00 am
Category : Project Manager
Job Type : Contract
Id : 7467
Region : Twin Cities

Seeking a QA Program Engineer to be responsible for compliance with applicable Corporate and Divisional policies and procedures.

Position Responsibilities:

  • Plans, executes, reports and follows-up on quality system audits (supplier and internal).
  • Actively participates in and supports departmental operations and responsibilities in accordance with existing internal procedures and external regulations and the ability to lead and/or facilitate group compliance activities associated with the quality system (e.g. audit programs, personnel training).
  • Monitors compliance with company policies, procedures and applicable regulatory requirements.
  • Makes decisions that are aligned with management objectives regarding work processes, plans and schedules in order to achieve department objectives.
  • Tracks and reports progress across projects and departmental commitments by reviewing schedules and due dates, identifying risks, and assisting teams with contingency plans.
  • Resolves project issues by working with team members, project customers, and others as appropriate.
  • Assists department and project leaders in developing and reporting appropriate performance and quality metrics.
  • Demonstrates an ability to apply, recommend, create or innovate quality tools and apply them effectively to a variety of business situations related to work and team environments.
  • Demonstrates skill(s) or competency(s) that differentiate him/her from the peer group.

Position Requirements:

  • Auditor certification from an industry recognized organization desired.
  • Hands-on knowledge of computer applications including use of the Internet, Word and Excel applications and presentation software such as Power Point.
  • Excellent written and oral communication skills.
  • Good organizational skills.
  • Good presentation skills.
  • Works well in a team-oriented, cross-functional environment.
  • Ability to handle multiple tasks and operate in a fast-paced environment.
  • A minimum of 7+ years experience in an FDA regulated industry (Biotech, Pharma or Medical Device manufacturing). Bachelor's Degree in Engineering, Chemistry, Biology or related science/technical field or an equivalent combination of education and work experience.
  • Must be able to travel domestic and international.



Posted: August 13, 2018, 2:33 pm
Category : Packaging Engineer
Job Type : Contract
Id : 7464
Region : Twin Cities

The Packaging Engineer will design and develop novel packaging solutions for new product development and sustaining engineering projects for Medical Devices. The role will also participate and lead cross functional teams consisting of R&D, Operations, Regulatory, Quality, Supply Chain and Labeling to ensure robust packaging development and engineering support across various manufacturing sites.

Day in The Life:

  • Responsible for the design, development, and support of package systems and processes for sterile & non-sterile medical devices including components, assemblies, and labels.
  • Supports the improvement and standardization of packaging on existing products with focus on compliance, performance and cost effectiveness.
  • Collaborate with Packaging and Labeling peers to identify and implement best practices, packages and processes.
  • Participate on cross-functional, cross-site project teams focusing on packaging, packaging technology and processes improvement
  • Utilize knowledge of FDA and ISO requirements related to packaging and labeling, ensuring robust package validation and qualification
  • Draft technical documentation including package testing protocols and validation associated with the qualification and release of package designs
  • Process development and support for packaging assemblies for manufacturing
  • Develop plans to establish proof of shelf life, accelerated and real time.
  • Support and execute all aspects of packaging development and testing as required
  • Actively participate in the identification of suppliers, testing and approving materials, including liaison with the vendors.

Must Have:

  • 2+ years experience with a BS Packaging or related engineering field (e.g. Mechanical or Materials); 0-2 years with MS
  • Medical device or Pharma packaging experience
  • Knowledgeable in ISO, ASTM, ISTA standards related to packaging.
  • Solid proficiency in MS Word, Excel and statistical analysis software
  • Familiarity with FDA quality assurance requirements for design and manufacturing.
  • Ability to travel up to 15%, both domestic and international.

Nice to Have:

  • Certified Packaging Professional (CPP) preferred.
  • Experience with ethylene oxide, steam, liquid chemical, and radiation sterilization methods
  • Experience with process development and design of experiments (DOE) methodology Experience with Design Verification and Process Validation.
  • Experience with sterile barrier sealing equipment and processes.
  • Experience with MiniTab, Microsoft Project, Solidworks and change control software.


Posted: August 13, 2018, 8:18 am
Category : Drafter
Job Type : Contract
Id : 7462
Region : Twin Cities

Seeking a Design Drafter to apply Computer Aided Engineering (CAE) software, design/engineering methods and techniques in the design of components, assemblies and test fixtures. Develop solid models to capture design intent and for computational analysis to enable 1st pass success. Stay current on technology advancements in CAE which includes application software, materials and manufacturing processes.

 

Position Responsibilities:

  • Solid modeling of objects (component, assemblies, test fixtures) to capture design intent.
  • Provide services to enable proper data management.
  • Partner with engineering to improve the product delivery process and outcomes (Identify opportunities, investigate solutions and implement change).
  • Partner with design teams to deliver designs that are within manufacturing capability and with a predicated high yield.
  • Work directly with engineers on design iterations and adherence to best company practices.
  • Apply "Top Down" mechanical modeling techniques to designs.

 

Basic Requirements:

  • HS Diploma or GED
  • Practical experience applying SolidWorks to mechanical designs
  • Excellent communication skills
  • Strong mechanical aptitude

 

Desired/Preferred Requirements:

  • Associate (2 year) Mechanical Design Technical degree with 10 years of design experience.
  • Deep knowledge and practical experience applying SolidWorks.
  • Skilled in day to day usage of PDM Pro to manage SolidWorks model/drawing data.
  • Practical experience in applying CAE in DOE's and tolerance studies in SolidWorks.
  • Perform computational analysis as a service to engineering and production.
  • Good teamwork and interpersonal skills, good communication and presentation.
  • Identify opportunities in the design environments which target increasing productivity, product
  • manufacturability and yield.
  • Develop design environment standard work and best practices and drive implementation internally and with suppliers.

 



Posted: August 10, 2018, 9:37 am
Category : Electrical Engineering
Job Type : Permanent
Id : 7459
Region : Twin Cities

The Principal Product Electrical Engineer will support existing ablation systems and develop electrical circuits, test methods, and related documentation for advanced ablation systems as a team member of the Research and Development group to support the Interventional Oncology business unit. The candidate will assist in all projects ranging from concept and technology development through commercialization and post-market support.

 

Principal Responsibilities:

  • Develop and modify electrical systems and devices for released products, prototypes, production tools, and test fixtures in a highly regulated environment.
  • Create related documentation and support materials in conjunction with design and development activities.
  • Experience leading small to medium scope projects with cross-functional team members.
  • Familiar with the transfer to manufacturing process and experience authoring and modifying work instructions.
  • Ability to work with Systems, Mechanical, Electrical and Software engineers while collaboratively designing medical devices.

 

Education and Experience:

  • Bachelor's degree in Electrical Engineering
  • 5+ years of experience developing electrical systems including analog and digital circuitry
  • Experience with developing embedded circuits including designs with FPGAs is desirable
  • Hands-on experience with troubleshooting designs, building prototype devices, and performing experiments
  • Experienced with specifying and developing production tests for electrical designs, writing protocols, analyzing results, and writing reports
  • Competence with schematic entry and PCB layout tools is required
  • Experienced with developing and verifying products to applicable medical safety and EMC regulations
  • Experience with regulated medical devices and quality systems is desirable
  • Capable of evaluating circuit designs using electronic test equipment including oscilloscope, signal generator, spectrum analyzer, and impedance analyzer
  • Experienced with analog and digital simulation software tools
  • Capable of reading and understanding electrical component specifications

 

Skills and Attributes:

  • Highly self-motivated and directed
  • Keen attention to detail
  • Ability to create clearly-worded documents describing design ideas, test details, and project status
  • Ability to adapt and learn new technologies
  • Proven analytical and problem-solving abilities
  • Ability to exercise independent judgment and discretion by effectively prioritizing, planning, tracking and executing team activities in a high-pressure environment
  • Strong customer service orientation
  • Experience working in a team-distributed, collaborative environment
  • Ability to manage and prioritize work load, multi-task and manage a diverse mix of issues, responsibilities and challenges
  • Exceptional ethical standards including the ability to be very discrete in the handling of confidential and privileged information
  • Self-starter with a hands on, pragmatic approach and a "can do" attitude


Posted: August 8, 2018, 7:40 am
Category : Project Manager
Job Type : Contract
Id : 7458
Region : Twin Cities

Seeking a R&D Engineering Project Manager to update risk assessment for company medical device products.  This candidate will help with the pilot project to develop a plan that various divisions can implement for mapping failure codes into existing and future documentation. This position will be responsible for implementing and maintaining the effectiveness of the quality system

 

Position Requirements:

  • Bachelors degree plus 8 or more years Engineering experience (systems engineering, electrical, biomedical)
  • Project management: organizing, planning, writing plans and processes
  • Familiarity with FMEAs, working with design controls in medical device, automotive, or defense industries
  • Complaint handling and analysis experience a plus


Posted: August 3, 2018, 12:33 pm
Category : Electrical Engineer
Job Type : Contract
Id : 7452
Region : Twin Cities

Seeking an entry level Electrical Engineer to review and understand Failure Analysis reports, and accurately and efficiently translate the conclusions into data entries in the Global Complaint Handling (GCH) system. This candidate will also create and implement Engineering Change Orders/Actions (CO/CA) in company’s Product Data Management system; this includes leading the cross functional change review and approval process. While taking direction from the Sr. Engineering staff in the group, the person in this role will have an opportunity to learn different instrument design elements and gain exposure to how the cross functional groups operate.

Position Responsibilities:

  • Leverage area expertise and learn new design elements to quickly become the design expert as issues require.
  • Communicate technical details and achieve the necessary understanding and trust from non-technical audiences.
  • Design, analyze, and test analog and digital circuits either independently or while working closely with a design technician.
  • Create test plans and reports, and coordinate product testing.
  • Create other high quality formal documentation and records.
  • Evaluate returned product to determine the root cause of field returns and establish design improvements.
  • Manage, configure, track, verify, and transport test samples.
  • Remaining availability will typically involve issues that are reactive and are often urgent, so priorities change frequently. Some issues requiring resolution may contain a mechanical element as well.

Position Qualifications:

  • 0 to 3 years industry experience
  • Bachelor of Electrical Engineering or another Engineering discipline with a strong focus in electronics



Posted: August 3, 2018, 6:46 am
Category : Manufacturing Engineer
Job Type : Contract
Id : 7453
Region : Twin Cities

Seeking a Process Development Engineer to work with cross-functional teams to develop processes that produce Medical Device products of the highest quality and reliability.

A Day in the life:

  • Develop and implement new processes for existing or new products, including Fixturing, Equipment, and Process qualification; creation of Manufacturing procedures, BOMs, Routers, Item Masters, Routings
  • Provide input into the design of new products to improve their reliability and ease of manufacture
  • Manage the development of new and improved products, components, and processes per the design plan.
  • Manage required builds for new product development in a pilot or production setting, including training of operators, coordination with production planning, preparing manufacturing procedures and work-orders as well as assist in troubleshooting assembly issues.
  • Work effectively in highly cross-functional project teams and work independently to accomplish project goals.
  • Address broad design issues that impact the success of current and future products.
  • Develop methods, techniques, and evaluation criteria for product related research and development.
  • Partner with Development and Operations and utilize DRM /COS/ lean principles to create technical solutions for product assembly that are consistent with organization objectives.
  • Daily interaction with pilot development teams providing hands-on support for development builds.
  • Create equipment specifications to procure and integrate systems that will deliver highly capable processes, cost effective lean tooling and equipment that enable COS.
  • Utilize DRM to thoroughly evaluate requirements for new products in terms of the test method, process capability and relationship to the customer needs.
  • Lead development activities through interactions beyond work group with frequent management interactions to achieve business commitments including attainment of Safety, Quality, Service, Project Schedule and Cost goals.
  • Follow established procedures to perform and lead improvement initiatives for detailed, accurate, and compliant engineering documentation for Master Validation Plans, pFMEA, Equipment Installation, Characterization, Qualification and Validation.

Minimum Requirements:

  • Bachelor of Science in Engineering
  • Minimum of 2 years manufacturing engineering experience or MS degree
  • Knowledge of computer applications (i.e.: Microsoft Project, Word, Excel, PowerPoint, Windows, Visio, etc.) required.
  • Knowledge of statistical techniques and software.
  • Experience in developing and / or implementing new processes for existing or new product.
  • Equipment and process validation (IQ,OQ,PQ)
  • Fixturing Design, Creation of Manufacturing Procedures, Bill of Materials (BOMs), Routings, Item Masters
  • Knowledge of Good Manufacturing Practices (GMP) and applicable Quality System Standards.
  • Technical knowledge of manufacturing processes
  • Experience handling multiple tasks concurrently
  • Experience interpreting mechanical drawings
  • Experience conceiving and communicating mechanical design concepts to drafting team
  • Excellent data analysis skills and proficient in the use of statistical tools in problem solving
  • Computer skills such as Word and Excel
  • Knowledge of quality systems

Nice to Have:

  • DRM Green Belt Certification
  • Experience with Medical Device Regulation
  • Experience in medical product mfg / assembly operations
  • Experience with project management and using Microsoft Project
  • Tool design experience


Posted: August 3, 2018, 6:43 am
Category : Project Manager
Job Type : Contract
Id : 7457
Region : Twin Cities

The Sr. Project Manager is responsible for leading, establishing, and driving execution of product release cadences for medical device products. Projects within scope will include, but are not limited to: Release Product Engineering (RPE), CAPAs, and Sustaining Engineering. This position requires broad cross-functional knowledge and comprehensive business management skills.

POSITION RESPONSIBILITIES:

  • Accountable for overall project execution. Including: project planning, budgeting, schedule creation, and execution.
  • Establishes product release strategy through multiple project inputs, establishing operational plans and execution.
  • Leads and manages site-specific and cross-functional teams established with the purpose of successfully accomplishing the objectives of the product release program.
  • Monitors progress toward pre-established objectives, assesses risks, and implements strategies to ensure successful program execution.
  • Directs the work of site-specific and cross-functions through a matrix organization.
  • Secures site-specific and cross-functional commitments, maintaining milestones and budget. Deploys team resources to meet project/program objectives.
  • Maintains effective communication and interface with various leadership teams.
  • Ensure effective project transition relevant to development, quality, manufacturing, distribution, regulatory, and commercial entities.
  • Provides input to Functional Managers on team member performance, as needed.
  • Assesses project issues and develops resolutions to meet productivity, quality, and client-satisfaction goals and objectives.
  • Develops mechanisms for monitoring and reporting project progress and for intervention and problem solving with project managers, line managers, and clients.
  • Ensures the project/program complies with all aspects of the quality policy/system.
  • Ensure appropriate departmental resources are assigned to the program/project and are available to effectively maintain the quality system (people, facilities, tools, and training).
  • Problems and issues faced can be complex, difficult and undefined requiring detailed information gathering, analysis and investigation to understand the problem.

BASIC QUALIFICATIONS:

  • Bachelor's degree with 4+ years of job-related experience
  • OR Master's degree with 2+ years of job-related experience
  • 2+ years of project management experience

DESIRED/PREFERRED QUALIFICATIONS:

  • 2+ years coordinating manufacturing site activities.
  • 5+ years in medical device product development, or other highly regulated environment.
  • Project Management Professional (PMP) certified.
  • Highly developed skill set in project leadership practices including ability to balance risk, effectively influence diverse teams, and ownership of responsibility for outcomes.
  • Excellent downward, lateral, and upward communication skills.
  • Good balance of high level strategic and detailed tactical thought processes.
  • Demonstrated track record of successfully leading projects/programs to completion.


Posted: August 3, 2018, 6:26 am
Category : Mechanical Engineer
Job Type : Contract
Id : 7456
Region : Twin Cities

The Product Engineer works under general supervision to provide global product release support and guidance to execute the release of design for release product engineering (RPE) programs. Provides support, as needed, to execute the release of design for new product introduction (NPI) programs.

POSITION RESPONSIBILITIES:

  • Analyzes, troubleshoots, and provides technical skills to RPE programs. Provides support, as needed, to NPI programs.
  • Participates in the planning and coordination of engineering projects, generating project-level documentation as appropriate.
  • Monitors projects and participates in improving operating efficiency.
  • Generates and completes plans and reports or other documentation in compliance with applicable Company procedures.
  • Provide work direction and guidance of strategy and execution to cross-functional partners in the area of product release.
  • Provide technical business unit knowledge and project direction to global cross-business teams supporting common process and systems.
  • Supports the development and approach to solutions for meeting business objectives for product release.
  • Supports the liaison of cross-functional alignment in the areas of Configuration Management, Development, and related Operations functions.
  • Supports defining the direction for new products, processes, standards, or operational plans by developing and implementing solutions to complex problems.
  • Responsible for production support engineering with respect to technical feasibility of product configurations
  • Assumes oversight for device and/or internally produced or externally purchased components for specified product portfolios
  • Follow all work/quality procedures to ensure quality system compliance and high-quality work.
  • Perform other related tasks as assigned.

BASIC QUALIFICATIONS:

  • Bachelor’s degree with 2+ years of job-related experience
    OR Master’s degree with 6+ months of job-related experience

DESIRED/PREFERRED QUALIFICATIONS:

  • Experience working in a regulated environment.
  • Experience working in a medical device environment.
  • Experience working with FDA, ISO, EN, and/or GMP standards.
  • Proven, strong detail-oriented work skills.
  • Proven ability to easily adapt to multi-task and shift priorities effectively and expediently.
  • Proficiency with common software packages (e.g., Word, Excel, Adobe Reader).
  • Demonstrated ability to work independently and with a team.
  • Demonstrated involvement in process definition and improvement.
  • Formal training in Product Data or Lifecycle Management systems.
  • Ability to learn and adapt to changes in technology, processes, or requirements.



Posted: August 3, 2018, 6:20 am
Category : Mechanical Engineer
Job Type : Contract
Id : 7455
Region : Twin Cities

Looking for a Mechanical Engineer to work cross functionally to bring products from concept through development and into production. Mechanical Engineers are responsible for the mechanical design, drawings, prototype fabrication, DFM, and test for Class II/III medical devices.

Responsibilities:

  • Mechanical design and evaluation of a wide range of electromechanical medical devices with potential applications in instrumentation, fluid management, motion control, pneumatics, and power transmission.
  • Collaborate with customers, human factors engineers, industrial designers, and usability experts to develop creative, clinically relevant products.
  • Mechanical design of plastic, metal and/or machined enclosures in accordance with applicable international standards and certification agencies.
  • Research, develop, design, and evaluate electromechanical components, assemblies, fixtures, and equipment; and assist in their supplier selection.
  • Provide mechanical requirements, design output specifications, and other appropriate documentation suitable for submission to regulatory bodies.
  • Assist in design reviews, project plan definition, and budget estimating.
  • Employ statistical techniques for manufacturability and reliability assessments.
  • Utilize hazard analysis, DFMEA and other tools to ensure product safety.
  • Prescribe and perform design feasibility, evaluation and verification testing.
  • Provide direction to internal and external engineering support personnel.
  • Interface with internal manufacturing representatives and external suppliers to define assembly processes and ensure manufacturability.
  • Create and validate fixtures for test and manufacturing.
  • Provide consulting and sustaining engineering support to manufacturing.

Qualifications:

  • B.S. in mechanical engineering with a preference for advanced degrees.
  • 5-10 years engineering experience with a preference for the medical industry.
  • CAD proficiency, preferably SolidWorks.
  • Ability to create drawings and write detailed, compliant technical documents.
  • Familiarity with a wide range of materials and fabrication techniques.
  • Hands-on engineering aptitude, including fabrication of prototypes and fixtures.
  • Strong analytical and problem solving skills.
  • Results orientated with a bias for action and timely completion.
  • Strong interpersonal, teamwork, and communication skills.
  • Project management abilities with a customer service orientation.



Posted: August 2, 2018, 9:37 am
Category : Electrical Assembler
Job Type : Contract-to-Hire
Id : 7454
Region : Twin Cities

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

RESPONSIBILITIES:

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

REQUIRED:

  • Experience in assembly and wiring
  • Ability to use hand tools
  • Good communication skills
  • Ability to prioritize and multi-task
  • 2+ years prior experience

DESIRED:

  • Knowledge of UL508A standards
  • Prefer someone with AutoCAD Electrical experience but not necessary



Posted: August 1, 2018, 1:57 pm
Category : R&D Engineer
Job Type : Contract
Id : 7451
Region : Twin Cities

Seeking a Research and Development Engineer to work on Medical Device product development processes. Looking for a talented individual to work with cross-functional teams on component selection, qualification, and design transfer in EP Integrated lab systems. 

 

Position Responsibilities:

  • Responsible for the development, qualification, and release of sustaining component updates for EP Integrated Lab Systems.
  • Enhances and documents medical device functionality
  • Assist in the development of product specifications
  • Collaborate with product management, customer care, quality, regulatory, production, and other engineering disciplines to deliver upon product delivery objectives and business goals  
  • Facilitate packaging and transmitting drawing/technical files to internal and external stakeholders
  • Field, facilitate questions from stakeholder, communications between supplier and Abbott  

 

Required Qualifications:

  • Experience with audio/visual hardware
  • Experience with display technologies and video testing
  • Experience with test protocol development/execution
  • Experience/familiarity with EMC/EMI & safety testing
  • Familiarity with the EP space including examining ECG waveforms, fluoroscopy, and ultrasound sources. 
  • Experience with Word, Visio, and similar documentation tools.
  • Experience with engineering change process and enterprise/document management systems such as Windchill.
  • Capable of producing polished, detail-oriented written documentation
  • Strong analytical and problem solving skills.
  • Organized and on-time with ability to work in a structured process environment.

 

Preferred Qualifications:

  • Experience MS Windows and Linux Operating System installation and configuration, including driver troubleshooting and OS enhancements.
  • Experience working with Linux systems, window managers and video input/output.
  • Experience working with high-end workstations, network hardware, internal cards like frame grabbers and external accessories like printers, monitors, touchscreens, etc.
  • Familiarity with software revision control system
  • Good oral presentation and collaboration skills.


Posted: July 30, 2018, 9:46 am
Category : Manufacturing Engineer
Job Type : Contract
Id : 7450
Region : Twin Cities

The Process Development Engineer works closely with Design, Program Management, Sourcing, Quality, Reliability, and Operations to develop processes that produce products of the highest quality and reliability.

A Day in the life:

  • Develop and implement new processes for existing or new products, including Fixturing, Equipment, and Process qualification; creation of Manufacturing procedures, BOMs, Routers, Item Masters, Routings
  • Provide input into the design of new products to improve their reliability and ease of manufacture
  • Manage the development of new and improved products, components, and processes per the design plan.
  • Manage required builds for new product development in a pilot or production setting, including training of operators, coordination with production planning, preparing manufacturing procedures and work-orders as well as assist in troubleshooting assembly issues.
  • Work effectively in highly cross-functional project teams and work independently to accomplish project goals.
  • Address broad design issues that impact the success of current and future products.
  • Develop methods, techniques, and evaluation criteria for product related research and development.
  • Partner with Development and Operations and utilize DRM /COS/ lean principles to create technical solutions for product assembly that are consistent with organization objectives.
  • Daily interaction with pilot development teams providing hands-on support for development builds.
  • Create equipment specifications to procure and integrate systems that will deliver highly capable processes, cost effective lean tooling and equipment that enable COS.
  • Utilize DRM to thoroughly evaluate requirements for new products in terms of the test method, process capability and relationship to the customer needs.
  • Lead development activities through interactions beyond work group with frequent management interactions to achieve business commitments including attainment of Safety, Quality, Service, Project Schedule and Cost goals.
  • Follow established procedures to perform and lead improvement initiatives for detailed, accurate, and compliant engineering documentation for Master Validation Plans, pFMEA, Equipment Installation, Characterization, Qualification and Validation.

Position Requirements:

  • Bachelor of Science in Engineering; Plastics or Materials Engineering preferred
  • Minimum of 2 years manufacturing engineering experience or MS degree
  • Knowledge of computer applications (i.e.: Microsoft Project, Word, Excel, PowerPoint, Windows, Visio, etc.) required.
  • Knowledge of statistical techniques and software.
  • Experience in developing and / or implementing new processes for existing or new product.
  • Equipment and process validation (IQ,OQ,PQ)
  • Fixturing Design, Creation of Manufacturing Procedures, Bill of Materials (BOMs), Routings, Item Masters
  • Knowledge of Good Manufacturing Practices (GMP) and applicable Quality System Standards.
  • Technical knowledge of manufacturing processes
  • Experience handling multiple tasks concurrently
  • Experience interpreting mechanical drawings
  • Experience conceiving and communicating mechanical design concepts to drafting team
  • Excellent data analysis skills, and proficient in the use of statistical tools in problem solving
  • Computer skills such as Word and Excel
  • Knowledge of quality systems

Preferred Skills:

  • Preference will be given to candidates with experience with at least one of the following: Injection Molding, Sputtering, Materials Science
  • DRM Green Belt Certification
  • Experience with Medical Device Regulation
  • Experience in medical product mfg. / assembly operations
  • Experience with project management and using Microsoft Project
  • Tool design experience



Posted: July 26, 2018, 12:57 pm
Category : Electrical Designer
Job Type : Contract-to-Hire
Id : 7449
Region : Twin Cities


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

 

Accountabilities:

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

 

Skills:

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

 

Experience:

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

 

Education:

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


Posted: July 26, 2018, 9:40 am
Category : Manufacturing Engineer
Job Type : Contract
Id : 7447
Region : Twin Cities

Seeking a Senior Manufacturing Engineer to design and develop manufacturing processes, tooling, and fixtures in order to meet daily production schedules while enhancing productivity and product quality.

Essential Functions:

  • Manage projects which include new production equipment, process improvements and cost reductions while supporting new product introductions.
  • Provide guidance to other engineers and technicians.
  • Provide technical mentorship to engineers and technicians Conduct Process FMEAs and Process Validations Improve product quality, labor efficiency, and throughput through the use of Lean manufacturing concepts Coordinate the design, procurement, build and debug of tooling, machinery and test equipment Work with Product Development to ensure Design for Manufacturability
  • This individual should be innovative, resourceful, and work with minimal direction
  • Excellent organization, problem solving, communication, and team leadership skills
  • Work effectively with cross-functional teams
  • Support all Divisional initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements
  • CAPA experience required



Posted: July 26, 2018, 6:33 am
Category : Electrical Engineer
Job Type : Permanent
Id : 7446
Region : Twin Cities

The primary role of the Electrical Engineer is to design, develop and test all aspects of electrical components, equipment and hardware related to company systems while applying knowledge of engineering concepts, practices and procedures. This includes motion control hardware, laser control hardware, a variety of electro-mechanical device controls, and support of PLC based hardware and software.

Essential Duties and Responsibilities:

  • Evaluate and select components that will provide a technically superior and cost effective solution.
  • Work with suppliers, applying standard engineering practices, to develop component specifications.
  • Provide support to an Engineering team for new product and feature development.
  • Review customer specific requirements, and satisfy customer needs through the design, test, and documentation of unique solutions for existing products.
  • Create testing and qualification protocols to validate and verify designs.
  • Create, implement and maintain documentation, including Bill of Material maintenance and schematics, using the company specific ERP system and AutoCad Electrical software.
  • Provide technical support to manufacturing and service personnel.
  • Create work procedures and good practice documentation, and lead training classes for company personnel based on their content.
  • Make recommendations to customers regarding machine usage and installation.

Qualification Requirements:

  • BS/MS in Engineering or equivalent
  • Experience with PLC based hardware and software.
  • Experience with multi-axis machine tool design is preferred.
  • 1-3 years of experience as a designer or engineer in a capital equipment manufacturing environment
  • Demonstrated verbal and written communication skills.


Posted: July 24, 2018, 12:13 pm
Category : Packaging Engineer
Job Type : Contract
Id : 7444
Region : Twin Cities

Seeking a Packaging Engineer to be responsible for the design, development, and support of package systems and processes for sterile medical devices including components, assemblies, and labels.

Position Responsibilities:

  • Accountable for the development and implementation of packaging for existing and new medical products and devices including class-II and class-III implantable products, drug/device combination products, and accessories.
  • Leads the improvement and standardization of packaging on existing products with focus on performance and cost effectiveness.
  • Actively collaborate with Packaging and Labeling peers within to identify and implement best practices, packages and processes.
  • Participate on cross-functional, cross-site project teams focusing on packaging, packaging technology and processes improvements
  • Utilize knowledge of FDA and ISO requirements related to packaging and labeling, ensuring robust package validation and qualification
  • Draft technical documentation including package testing protocols and validation associated with the qualification and release of package designs
  • Process development and support for packaging assemblies for manufacturing
  • Develop plans to establish proof of shelf life, accelerated and real time.
  • Coordinate projects and deadlines working with P&L lead to ensure all new product and package improvement deadlines are met.
  • Execute all aspects of packaging development and testing as required
  • Serve actively in the identification of suppliers, testing and approving materials, including liaison with the vendors.

Basic Qualifications:

  • 5 years experience with a BS Packaging or related engineering field (e.g. Mechanical or Materials); 3 years with MS
  • Medical device or Pharma packaging experience
  • Knowledgeable in ISO, ASTM, ISTA standards related to packaging.
  • Solid proficiency in MS Word, Excel and statistical analysis software
  • Familiarity with FDA quality assurance requirements for design and manufacturing.
  • Ability to travel up to 15%, both domestic and international.

Preferred Qualifications:

  • Certified Packaging Professional (CPP) preferred.
  • Experience with ethylene oxide, steam, liquid chemical, and radiation sterilization methods
  • Experience with Design for Lean Sigma (DFLS), Design for Manufacturability (DFM), process development and design of experiments (DOE) methodology Experience with Design Verification and Process Validation.
  • Experience with sterile barrier sealing equipment and processes
  • Experience with MiniTab, Microsoft Project, Solidworks, MatrixOne, Agile, QAD. and SAP software


Posted: July 19, 2018, 12:36 pm
Category : Project Manager
Job Type : Permanent
Id : 7440
Region : Twin Cities

We have an exciting opportunity for a Project Manager to join our growing team. The Project Manager has the overall responsibility for the successful planning and execution of each project. They will be the main customer contact throughout the project and will be required to develop and maintain good working relationships both with the customer and between the various departments. This will include the planning and management of the scope of work, schedule and budget.

Major Areas of Accountability:

  • Provide direction and control for multi-disciplinary project teams. This includes all phases of the project from concept design through system design, integration, buy off/acceptance and factory installation.
  • Coordinate all communications with the customer during project execution. Update the customer as required on progress, scope, schedule and technical issues. Must maintain an excellent working relationship with customer at all times
  • Prepare and maintain the project budget based on the quotation, any Engineering Change Orders (ECOs) and all customer Purchase Orders.
  • Prepare and maintain the project schedule – for both internal and customer use, including coordination of all customer deliverables. Ensure that all project deliverables are complete and delivered as per schedule.
  • Assist department managers in manpower planning for their project(s).
  • Track all material costs and labor expenditures throughout the project, develop estimated to complete costs for both labor and materials required to complete the work and prepare and deliver weekly job status reports.
  • Continually review scope of work for any possible risk items. Develop, initiate and monitor any risk mitigation plans.
  • Monitor the scope of work as dictated by the original Purchase Order and any subsequent changes or requests (both internally and customer initiated). Develop Engineering Change Requests and negotiate ECOs with the customer and revise and maintain project budget and schedule accordingly.
  • Continuously monitor all project resources to ensure the project remains on target from a cost, scope, schedule and technical perspective.
  • Monitor the procurement process to ensure that materials are delivered as per current project schedule.
  • Schedule and manage all design reviews to ensure that the work is executed in a timely fashion and that the resultant designs meet scope, cost and schedule requirements.
  • Support the sales process for assigned accounts by interfacing with customers to clarify the RFQ, oversee the proposal development process, and present/sell the resulting proposal in coordination with Outside Sales.
  • Provide direction to the Applications Engineering group in developing proposals for assigned accounts, including defining the scope of effort and initial design concept.

Position Requirements:

  • Bachelor’s Degree in an Engineering discipline.
  • 7 to 10 years of relevant Project experience preferably in a test and development environment.
  • Solid technical knowledge including broad understanding of electrical, software and mechanical engineering concepts.
  • Must have US Person status.
  • Solid understanding of commercial aspects of contract engineering.
  • Strong influencing, negotiating and relationship building skills.
  • Strong communication skills; able to articulate the benefits and preferences of each product.
  • Prioritization/organization of work and multi-tasking skills are critical to this position.
  • Capacity to deal with a high workload and under pressure of meeting deadlines.
  • Excellent listening, negotiation and presentation skills.
  • Proficiency with Microsoft Office Suite.
  • Requires a strong initiative, proactive nature and a sense of urgency.
  • Ability to travel and work extended hours as job duties demand.


Posted: July 12, 2018, 2:15 pm
Category : Technicians
Job Type : Permanent
Id : 7439
Region : Twin Cities

The Electronic Engineering Technician conducts, maintains, tests and repairs electrical/electronic, mechanical, hydraulic, and pneumatic systems and components. The position applies knowledge of electrical/electronic and mechanical principles in determining equipment malfunctions and applies skills in restoring equipment to operation. The electronics technician provides skilled mechanical and electrical/electronic support to all areas of manufacturing.

 

Major Areas of Accountability:

  • Troubleshoots and repairs mechanical, hydraulic, pneumatic and electrical/electronic equipment, including programmable controls, numeral controls, power supplies, drives, gages and test equipment.
  • Plans and performs work requiring a thorough knowledge of electrical/electronic and mechanical theories and principles, writing specifications, local and national electrical codes, properties of various materials, and principles of operation and application of electronic equipment.
  • Installs, starts up and shuts down equipment in accordance with company safety procedures for machine activation and shutdown and in line with OSHA requirements.
  • Informs appropriate management of potential electrical/mechanical problems and inherent dangers involved.
  • Maintains company-required performance and maintenance records for identified equipment.
  • Performs preventive maintenance functions as directed.
  •  Assists with technical troubleshooting.

 

Qualifications:

  • 2 years of Technical School training in electronics, or equivalent military training.
  • Minimum of 3 years of work experience in electronics performing similar functions.
  • Solid analytical skills; able to resolve complex technical problems.
  • PCB Layout with Altium (preferred)
  • Ability to read and interpret technical drawings (blueprints and schematics) and specifications.
  • A thorough knowledge of electrical/electronic components and equipment, including the use of special instruments for diagnostic purposes.
  • Ability to read and interpret technical drawings (blueprints and schematics) and specifications.
  • Effective oral and written communication skills are required.
  • Must be a hands-on individual motivated to work in a dynamic, change-based environment.
  • Focus, great attention to detail and thoroughness in completing work tasks is necessary
  • Ability to lift and carry up to 40 lbs.
  • Ability to travel as necessary and work extended hours as job duties demand.
  • US Person status required.

 

Posted: July 12, 2018, 2:09 pm
Category : Electrical Engineer
Job Type : Permanent
Id : 7437
Region : Twin Cities

Seeking a Sr. Test System Design Engineer that will assume responsibility for Project Definition & Planning, Design Planning, & Development, CRM (Client Relationship Management), and Technical Leadership in a senior role. You’ll provide end to end project management of key deliverables.

Responsibilities:

  • Define project requirements and develop project design plans.
  • Design electrical/mechanical/software solutions that satisfy project requirements.
  • Lead or participate in design review meetings.
  • Senior level engineers will facilitate design reviews of own, and others’ work.
  • Collaborate with other engineering disciplines to ensure effective overall system design.
  • Provide technical leadership on projects involving multiple engineers, including leading the overall design approach, partitioning work among the team and sequencing detailed design activities to support the overall project schedule.
  • Work closely with project manager to coordinate project activities and meetings.
  • Develop and/or evolve engineering processes and provide implementation and training leadership.
  • Support the sales process by providing technical expertise to the customer.
  • Provide effective communication with project team members, including project status, risks, and suggestions to project leadership.
  • Collaborate with customers as needed to accomplish customer goals.

Qualifications:

  • Undergraduate degree in an Electrical Engineering discipline or equivalent experience in an electronics manufacturing firm or engineering services.
  • Effective communication skills with all stakeholders; project team members, management, clients, etc.
  • R&D or testing at PCB and final assembly levels.
  • Effective project management skills; status, problem resolution, risk management.
  • Demonstrated focus on quality initiatives, process improvements, etc.
  • Travel availability of 10% to 15% to client locations for meetings and/or system installations.
  • At least 10 years engineering experience and skill competency in one or more of: Electronic hardware design, digital or analog, or both.
  • Automated functional test development.
  • At least 10 years engineering experience and skill competency in one or more of: Application or embedded software development in C/C++, C#, VB.Net, NI LabView/TestStand program development (CLD desirable), Python experience a plus.


Posted: July 12, 2018, 2:00 pm
Category : PLC Controls
Job Type : Permanent
Id : 7433
Region : Twin Cities

The Controls Engineer role will provide expertise in robotic electrical controls design and implementation. Work with the sales team to provide custom controls designs which meet the requirements of our customers. Improve and upgrade control systems as required by changing technology and increasing complexity of product mix. Develop embedded software for specified products.

ESSENTIAL RESPONSIBILITIES:

  • Performs conceptual design of packaging machinery and systems controls, including component selection, system integration, programming and development of product documentation.
  • Supports equipment sales by translating marketing specifications and customer needs into cost effective control solutions that meet internal and external requirements. Write PLC and HMI code for packaging machinery using Allen Bradley. Write structured text robotic code for Hamer-Fischbein palletizer lines.
  • Works with suppliers to properly specify components, investigate new technology and procure parts/systems for prototype projects.
  • Interacts with field service technicians and production to validate control designs and address improvements. Train technicians and production as necessary to support new designs. Travel to customer sites as required to support installations and resolve customer issues that service techs cannot resolve on their own.
  • Efficiently and accurately create software for Robotic Palletizers. Design control panels for various machines.

POSITION REQUIREMENTS:

  • 2-year Automated Systems and Robotics Degree required
  • 3+ years' experience with controls design, robotic programming, HMI programming, variable speed drive and servo control
  • Experience with Solidworks and/or AutoCAD a plus
  • Ability to travel approximately 15%


Posted: July 10, 2018, 10:19 am
Category : Management/Operations
Job Type : Permanent
Id : 7430
Region : Twin Cities

The Production Manager is responsible for directing all SMT and assembly production activities within the company while ensuring product quality and productivity performance meets or exceeds goals. This role requires an active presence on the shop floor throughout the workday. This candidate will maintain smooth and constant product flow across all assembly lines by coordinating personnel and production jobs to meet output objectives. Perform first article inspections, process auditing, and quality checks. Provide training and assure adequate cross-training is maintained. Coordinate production activities with Sales Administration, Production Planning, and Shipping & Receiving. Perform trouble-shooting and root-cause analysis as required and proactively seek continuous improvement opportunities.

Job Description:

  • Ensure all product manufactured meets quality requirements.
  • Maintain smooth and constant product flow across all assembly lines by coordinating personnel and production jobs to meet output objectives.
  • Perform first article inspections, process auditing, and quality checks.
  • Perform trained production tasks, as necessary, to maintain production flow.
  • Provide training and develop/maintain an adequately cross-trained team to assure full process capability coverage at all times.
  • Hire personnel as required.
  • Perform performance appraisals, initiate and manage disciplinary and performance improvement actions.
  • Using leadership skills help to maintain high morale and motivation of the Production Team.
  • Coordinate production activities with Sales Administration, Production Planning, and Shipping & Receiving.
  • Perform rapid and effective trouble-shooting and root-cause analysis as required.
  • Maintain reliable and safe manufacturing processes.
  • Proactively seek continuous improvement opportunities and develop innovative solutions for improving production rates, efficiencies, yields, costs and changeovers.
  • Work with manufacturing and engineering to specify, develop, test and implement new and enhanced capabilities.
  • Develop, maintain and manage work instructions, quality standards, and process documents.
  • Coordinate and oversee calibration and maintenance activities with Engineering and contracted services.

Qualifications & Experience

  • B.Sc. Electrical or Mechanical Engineering
  • 5+ years of relevant experience in SMT circuit board assembly
  • Working knowledge of quality systems, quality control, process control, statistical analysis
  • Excellent oral and written communication skills
  • Ability to provide effective leadership and management of production personnel
  • Ability to supervise processes
  • Able to follow detailed work instructions
  • Perform Process Planning
  • Work with production Routings/Travelers and Bills of Materials
  • Self-motivated and ability to work well with and interact confidently with others
  • Good working knowledge of personal computers and standard office software with ability to develop and maintain spreadsheets
  • Ability to multi-task in fast-paced environment


Posted: July 9, 2018, 11:25 am
Category : Technicians
Job Type : Permanent
Id : 7431
Region : Twin Cities

Seeking a reliable SMT Machine operator to program, run and maintain the SMT equipment (paste printer, pick and place, AOI, reflow, conveyors). The ideal candidate must be knowledgeable of SMT component types and their packaging size and should be experienced with the total SMT process from set-up, feeders, programming knowledge, stencil, manual and automated printing, solder paste, and reflow ovens. This SMT Machine Operator must be capable of running a job through the complete SMT process with minimum supervision.

Qualifications & Experience:

  • Electronic component assembly
  • IPC-610 training/experience - Comprehensive understanding of IPC standards
  • Computer (Windows)
  • Knowledge of ESD procedures
  • Solder paste/stenciling
  • Ability to problem solve
  • Mechanical tooling/fixtures
  • Electronic component recognition
  • Simple electronic testing (DVM, etc.)
  • Ability to recommend future automation systems and participate in growth planning
  • Equipment installation
  • MS Word and Excel (basics)
  • Parts database (BOM) software user
  • Quality focus



Posted: July 9, 2018, 11:19 am
Category : Quality Engineering
Job Type : Contract
Id : 7427
Region : Twin Cities

Seeking a Senior Supplier Quality Engineer to be responsible for providing Pre-Market Quality Engineering support to New Product Development (NPD) working with Cross-functional Teams, to deliver quality parts, materials, and services, prevent defects, and allow the company to provide customers with the highest quality and reliable products. The Pre-Market Supplier Quality Engineer role will be responsible for providing technical guidance and quality compliance to newly qualified parts from NPD and implementing strategies for driving product quality and continuous improvement, ensuring purchased products and components are manufactured and qualified in accordance to applicable industry standards, regulatory requirements, and customer requirements.

POSITION RESPONSIBILITIES:

  • Extended member of product development team working in close liaison with the Quality CTM.
  • Responsible for execution of test method validation for all internal company Test Methods at Receiving Inspections to satisfy both regulatory and internal company requirements, including the preparation of high quality protocol and reports.
  • Collaborate with CE Engineer to develop the “Receiving Inspection Develop Product Acceptance Sampling Strategy” for New Products.
  • Responsible for the creation of new Supplier Control Plans.
  • Leads the implementation of Supplier Owned Quality (SOQ) during NPD.
  • Initiate Non-conforming documentation, propose and approve component dispositions.
  • Responsible to resolve deviations to the External Corporate Quality Agreement Template.
  • Co-ordinate the addition of New Suppliers to the Approved Supplier Listing (ASL) to support NPD.
  • Performs timely investigations into supplier quality issues which had resulted in a Supplier escape, PHO, Field Complaints, Field Actions, including coordinating material disposition, CAPAs, SCAPAs and Inspections.
  • Supports Quality Engagement with Sourcing for technical rigor & independent approvals.
  • May participate during Supplier Audits, and may own Audit tasks
  • Anticipate roadblocks; provide direction for navigating the quality system and supporting applications. Work in a cross-functional, collaborative, team-based environment; work with multiple sites in various locations and time
  • Serve as a technical resource for problem investigations; Support failure analysis of any product failures and associated corrective actions using both internal and external resources to guide root cause analysis and corrective action development.
  • Coordinate the preparation and of high quality presentation materials summarizing results of validations. Must be able to confidently present results to the QA CTM or company management.
  • Applies understanding of statistical concepts in conduction of validations.
  • Stay abreast of applicable regulatory requirements. Actively seek out opportunities to understand current industry direction. Essential requirements analysis including standards review and evidence of conformity.
  • Effect continuous improvement through the use of such tools as Lean, Six Sigma and Kaizen. All activities must be performed in compliance with the Quality System.
  • Perform detailed Root Cause Investigation of failed product or processes using various quality tools (5 Whys, 6 M, Ishikawa Diagram, Pareto Charts). Implement corrective and preventative actions.
  • Make timely decisions related to product and process quality; determine appropriate project plan when complete information is unavailable.
  • Assess, provide recommendations, and lead implementation of systems, processes and equipment for improvement and compliance to Good Manufacturing Practices at suppliers to ensure safe and effective products are produced. Provide written reports and supporting documentation for recommendations.
  • Maintain 100% Compliance to processes, procedures, and training.
  • Mentor less senior engineers.
  • Work with a high level of autonomy under minimal supervision.

BASIC QUALIFICATIONS:

  • Degree in Engineering or Quality discipline and a minimum 4-7 years prior relevant experience; with Masters or other Advanced Degree, minimum 2years prior relevant experience.

PREFERRED QUALIFICATIONS:

  • Supplier Controls process knowledge and Experience
  • Degree in Engineering or Quality discipline
  • ASQ certification in Quality Engineering
  • Proven leadership for process and system improvement
  • Experience and working knowledge of FDA regulations/ISO standards for medical devices
  • Strong interpersonal, organizational and project management skills
  • Demonstrated skills in decision making
  • Demonstrated ability in coaching/developing team members
  • Demonstrated communication skills, both verbal and written; Strong interpersonal communication and influence skill
  • Ability to work in a team based environment
  • Very strong in quality and compliance
  • Computer skills in MS Office and ERP systems desirable


Posted: July 9, 2018, 9:22 am
Category : Mechanical Designer
Job Type : Contract
Id : 7418
Region : Twin Cities

Seeking a Mechanical Designer to be responsible for performing conceptual design work for new products as well as proposing improvements to existing components. This candidate will work independently and creatively to solve problems and create solutions for tasks assigned, work closely with engineering to accurately assess the performance of proposed concepts and designs, and work directly with customers and medical advisors to develop new products. The Mechanical Designer will also work with suppliers to ensure the products manufacturability, and to develop robust methods of inspection.

Position Responsibilities:

  • Create designs for new devices, or improvements to existing products from rough sketches, written or verbal design input specifications.
  • Communicate design status and requirements to engineering and program management.
  • Contribute to identifying engineering requirements. Ensure feasibility and performance is assessed by leveraging engineering resources.
  • Participate in design related discussions with a range of internal and external customers, including medical advisors.
  • Specify and analyze tolerances and fits to ensure safe and effective function of devices.
  • Create solid models, drawings and assemblies that comply with applicable standards.
  • Work with suppliers and Quality Assurance to develop measurement techniques that are accurate and repeatable.
  • Propose and evaluate design changes to existing products.
  • Create and process change orders
  • Manage prototyping and debugging efforts
  • Contribute to design and project review meetings.

Position Requirements:

  • Associate’s degree (A. A.) or equivalent from two-year college or technical school.
  • 4+ years of experience with implantable medical devices, solidworks modeling, and drafting.
  • Must be familiar with molding plastic components, CNC machining techniques, rapid prototyping methods and measurement of components.
  • Must be an expert in CAD skills for creating solid models, dimensioning and tolerancing of drawings to ensure proper fit and fabrication.



Posted: July 6, 2018, 10:16 am
Category : Manager
Job Type : Contract
Id : 7425
Region : Twin Cities

Seeking a Program Manager to provide leadership to an extended project team comprised of individuals from Sourcing, Contract Manufacturers / OEM, Supplier Quality, and other functions as needed to drive successful development and commercialization of new products.

This position is responsible for the overall operations aspects including value stream planning, execution and successful implementation of activities in the development and introduction of new products.

The Program Manager has the responsibility to ensure that the voice of operations is properly captured and all team commitments and project contract metrics are met and communicated in a timely manner.

 

Position Responsibilities:

  • Lead cross functional teams including Sourcing, Contract Manufacturers / OEM, Supplier Quality, through the product development process to ensure successful completion of development projects and business goals.
  • Responsibility for all Operations activities and deliverables related to sourced
  • components and finished devices in product development planning and execution.
  • Ensure the quality policy/system is planned, understood, implemented and maintained.
  • Manages one or more developed or mature programs with well-defined program plans
  • and delivery methodologies.
  • Ensure Operations aspects of Quality System Compliance, Design History File, and Regulatory Submissions documentation.
  • Coordinate Development builds.
  • Lead the supply chain schedule risk burn down.
  • Ensure operations objectives are met: Labor, Burden, Material, Cycle Time, Capacity, First Run Yield, Cum Yield, Process Ppk, etc.

Basic Qualifications:

  • Bachelor's degree in Science, Engineering and 7+ years of relevant experience in the in one or more of the following functional areas, including product development, manufacturing and operations.
  • Master's degree and 5+ years or relevant experience in one or more of the following functional areas, including product development, manufacturing, and operations.
  • Proven Program Management experience leading cross functional teams in the commercialization of new products.
  • Experience in medical devices commercialization activities.

Desired/Preferred Qualifications:

  • Highly developed skill set in project leadership practices including ability to balance risk, effectively influence diverse teams, and ownership of responsibility for outcomes.
  • Excellent cross functional influence skills.
  • Ability to motivate and lead diverse group of individuals.
  • Strong verbal and written communication skills.
  • Negotiations and business development skills.
  • Self-Driven and results oriented.


Posted: July 2, 2018, 10:12 am
Category : Software Engineer
Job Type : Permanent
Id : 7424
Region : Twin Cities

We are looking for a senior software developer work on a wide variety of software projects for 3D sensors. This includes software for:

  • Communication with a wide variety of hardware such as cameras, motion control systems and a variety of sensors
  • Implementing image processing and other algorithmic procedures
  • Manufacturing and testing of production and development sensors
  • Software Development Kits and User interfaces for PC host applications

Core Responsibilities:

  • Defining software architectures that will help us promote agile development
  • Design and implement software for a variety of sensors projects such as host control APIs and end user applications.
  • Documentation of software designs and communications interfaces
  • Working with multi-discipline engineering teams throughout all phases of development
  • Supporting and troubleshooting sensor and software field issues

Required Experience:

  • BS Degree in Computer Science, Math or a related engineering field
  • 5+ years’ experience in software development in an engineering environment
  • Proficiency in C# and C++ development using Visual Studio
  • Proficiency with WPF and experience with user interface design.
  • Ability to work independently on projects as well as interact with multi-discipline engineering teams in a fast paced agile environment.
  • Strong technical communication abilities.
  • Strong Design and Architecture skills.

Preferred Experience:

  • Strong background in math and proficiency in basic image processing and 3D math functions
  • Ability to work with diverse SDKs, interfaces and libraries from external vendors
  • Experience writing software to communicate with external hardware such cameras, machine control systems and other types of sensors using TCP-IP, RS232, USB, PCIe and other standard protocols.
  • Experience with agile software development and working in a scrum team
  • Experience with training and mentoring


Posted: June 29, 2018, 6:14 am
Category : Controls Engineer
Job Type : Permanent
Id : 7420
Region : Twin Cities

Seeking a Senior Controls Engineer to provide and apply a broad range of control theory to design systems for motor driven products relating to controls integration, motor, feedback, cabling and safety within established/optimal time, cost, quality and performance objectives.

Qualifications:

  • Bachelor’s degree or equivalent in Electrical Engineering or related field.
  • At least 4 years of experience with control systems including servo and stepper controls and drives
  • At least 4 years of application experience of servo and stepper motors.
  • Working knowledge of UL and CE certification processes (desired).
  • Experience using Visual C++, C, and C++ programming.
  • Working knowledge of Dynamic HTML, XML, CSS, and Java Script (desired).
  • Ability to communicate effectively, both orally and in writing, with a wide variety of company personnel and others.



Posted: June 27, 2018, 7:30 am
Category : Software Engineer
Job Type : Permanent
Id : 7414
Region : Twin Cities

Seeking a Senior Software Engineer to join a software applications team for 3D printers and modelers.

 

POSITION RESPONSIBILITIES:

  • Build and deliver software that revolutionizes how things are made
  • Build and deliver great user experiences
  • Design and implement new product capabilities and workflows optimizing available technology and existing code
  • Design and implement software with the goal of maximizing reliability, correctness, ease of use, ease of maintenance, testability, and performance
  • Collaborate with our designers, product managers, front-end engineers, back-end engineers, and your team to solve tough product challenges with clean interfaces, experiences, and APIs
  • Troubleshoot, diagnose, and enhance existing software features, capabilities, and performance
  • Improve overall product infrastructure and reliability by creating sound designs, robust implementations, and appropriate unit and regression tests for both front-end and back-end code
  • Engineer and polish new libraries and components as we build out our JavaScript-based front-end applications

 

MINIMUM QUALIFICATIONS:

  • BS or BA in Computer Science, Software Engineering, Math, or other related science or engineering discipline
  • 3 years directly applicable experience working with desktop engineering, scientific, or computational-based applications
  • 3 years experience using C++ as a primary development language (25% of work)
  • 3 years experience using C#, .NET, and Microsoft development tools and environment
  • 3 years utilizing effective object-oriented design principles
  • 1+ year experience using JavaScript (75% of work)

 

PREFERRED QUALIFICATIONS:

  • Proficiency with at least one major JavaScript web framework such as React, Electron, AngularJS, Node.js, etc.
  • Demonstrated proficiency with CSS and HTML
  • Ability to architect front-end application code (JavaScript, CSS, HTML) for easy future maintenance and extensibility
  • Ability to write testable, resilient code, with effective unit and integration tests and meaningful documentation
  • Experience working with desktop engineering, scientific, or geometry-based applications
  • Ability to work with your scrum team to get the job done
  • Demonstrated ability to write testable, resilient code, with effective unit and integration tests and meaningful documentation
  • Experience with continuous integration build and test tools
  • Strong and effective verbal and written English communications skills
  • Track record of solving difficult and challenging technical problems
  • Motivated self-directed learner
  • Strong customer focus


Posted: June 25, 2018, 12:59 pm
Category : Software Engineer
Job Type : Permanent
Id : 7413
Region : Twin Cities

Seeking a Software Engineer to join a software application team for 3D printers and modelers.

 

POSITION RESPONSIBILITIES:

  • Build and deliver software that revolutionizes how things are made
  • Build and deliver great user experiences
  • Design and implement new product capabilities and workflows optimizing available technology and existing code
  • Design and implement software with the goal of maximizing reliability, correctness, ease of use, ease of maintenance, testability, and performance
  • Collaborate with our designers, product managers, front-end engineers, back-end engineers, and your team to solve tough product challenges with clean interfaces, experiences, and APIs
  • Troubleshoot, diagnose, and enhance existing software features, capabilities, and performance
  • Improve overall product infrastructure and reliability by creating sound designs, robust implementations, and appropriate unit and regression tests for both front-end and back-end code
  • Engineer and polish new libraries and components as we build out our JavaScript-based front-end applications

 

MINIMUM QUALIFICATIONS:

  • BS or BA in Computer Science, Software Engineering, Math, or other related science or engineering discipline
  • 1 year of front-end development experience using JavaScript (25% of work)
  • 1 year experience using C++ or C# with Microsoft development tools and environment (75% of work)

PREFERRED QUALIFICATIONS:

  • Proficiency with JavaScript frameworks and tools such as React, Electron, AngularJS, Node.js, three.js, protobuf, zmq, etc.
  • Working knowledge of CSS and HTML
  • Ability to architect front-end application code (JavaScript, CSS, HTML) for easy future maintenance and extensibility
  • Ability to write testable, resilient code, with effective unit and integration tests and meaningful documentation
  • Experience working with desktop engineering, scientific, or geometry-based applications
  • Experience with continuous integration build and test tools
  • Ability to work with your scrum team to get the job done
  • Strong and effective verbal and written English communications skills
  • Track record of solving difficult and challenging technical problems
  • Motivated self-directed learner
  • Strong customer focus


Posted: June 25, 2018, 12:53 pm
Category : Mechanical Designer
Job Type : Contract
Id : 7411
Region : Twin Cities


Seeking a Principal Mechanical Design Engineer to design and develop fixtures to be used for testing implantable Medical Devices.  Specific job skills needed to complete the above project:

  • Knowledge of how a SEM (Scanning Electron Microscope) works and how to interpret SE (Secondary Electron) and BSE (Backscattered Electron) images.
  • Familiarity with the application of acoustic emissions
  • Ability to read FEA (Finite Element Analysis) color contour plots
  • Ability to read and understand fracture mechanics principles
  • Ability to learn and apply Pyrolytic Carbon technology
  • Knowledge of mass finishing techniques
  • Excellent acute vision for microscope work
  • Requires a University Degree and minimum 7 years of relevant experience, or advanced degree with a minimum of 5 years of relevant experience


Posted: June 25, 2018, 8:30 am
Category : Technicians
Job Type : Contract
Id : 7408
Region : Twin Cities


Seeking a Manufacturing Technician to be responsible for performing functions associated with all manufacturing operations, including working with engineers in set-up and calibration tasks, as well as performing rework and quality testing related to the production of parts, components, subassemblies, and final assemblies. Determines and may assist in developing methods and procedures to control or modify the manufacturing process.

 

Essential Duties and Responsibilities:

  • Observes and complies with all safety rules and regulations. This includes QSR and ISO Standards.
  • Manage the production builds of multiple product lines, along with issues list, device improvements and changes.
  • Work with development engineering to manage the transfer of new products into production. 
  • Participates in the Material Review Board (MRB) decision process.
  • Identifies and implements corrective actions for manufacturing related issues.
  • Performs equipment setup and corrective, preventive and calibration maintenance as necessary.
  • Evaluates and orders necessary equipment, tools and fixtures.

 

Basic Qualifications:

  • AA Degree or equivalent work experience in related discipline
  • Experienced Manufacturing Technician working with electrical devices and systems. 3+ years of experience in a manufacturing role
  • Work experience in medical device manufacturing
  • Proven record of working closely and successfully with manufacturing and process development engineers
  • Basic understanding of medical device documentation requirements
  • Strong interpersonal communication (both written and oral).
  • Basic mechanical and electrical aptitude

 

Preferred Qualifications:

  • Working with electronic devices and products
  • Previous work history with printed circuit boards
  • Skilled in the use of electronic test & measurement equipment or in soldering of electronic components


Posted: June 20, 2018, 1:54 pm
Category : Production Supervisor
Job Type : Permanent
Id : 7402
Region : Twin Cities

Seeking a Production Supervisor that provides leadership and coaching to establish a cohesive and positive results driven team. This candidate will assist in driving culture change to promote continuous improvement and increased team capabilities with engagement to coach and mentor production team members in a fast paced manufacturing environment. This candidate will provide work direction to the production department to ensure the product produced meets or exceeds quality standards and is completed by scheduled ship date.

Key Responsibilities:

  • Maintains a safe and controlled manufacturing environment by educating and directing production team members on the use of all control points, tools, and resources; maintaining compliance with established policies and procedures.
  • Plans, develops and implements new methods and procedures designed to improve operations, minimize operating costs and effect greater utilization of labor and materials
  • Set production cell priorities by understanding business product flow from parts, build, test, packaging, and ship.
  • Interfaces with entire organization to ensure customer deadlines are met. This position will work closely with the Master Scheduler, Buyers, Customer Service Manager and Program Management.
  • Identify, troubleshoot and resolve bottlenecks, process failures, production procedures, staffing issues, supply chain part shortage problems, and/or training deficiencies
  • Establish process, protocol and involvement for new product transition for production release

Position Requirements:

  • Two year degree in manufacturing or related field.
  • Minimum of 5 years of supervisor experience in a manufacturing environment or 3 years of experience with a BS degree.
  • Experienced in Lean manufacturing by using strong influence capability and ability to divert decision making.
  • Familiar with production work orders or schedules to meet customer delivery and quarterly revenue.
  • Experienced in ERP system (QAD). Proficient in Microsoft Excel, Power Point, and Word.

Preferred Qualifications:

  • Familiar with optomechanical / electromechanical assembly operations.
  • Tracked record of supervisor experience.
  • Coach and mentor production team members’ disciplinary but in a professional manner.
  • Having a continuous improvement mindset to bring innovative ideas to the organization.
  • Preferably a 4 year degree in manufacturing, business, or related field.


Posted: June 18, 2018, 11:40 am
Category : Electrical Assembler
Job Type : Permanent
Id : 7401
Region : Twin Cities

 

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

RESPONSIBILITIES:

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

 

REQUIRED:

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

 

DESIRED:

  • Knowledge of UL508A standards


Posted: June 15, 2018, 2:50 pm
Category : Technicians
Job Type : Contract-to-Hire
Id : 7393
Region : Minnesota

Seeking a Senior Machine Builder with 10 years + experience of building, repairing, installing custom automated machines. The ideal candidate should have working knowledge of:

  • Blue print reading including mechanical, pneumatic and schematic drawings
  • Drafting of detail machine parts
  • Machine assembly
  • Machining
  • Welding
  • Sheet metal work
  • Painting and plating process
  • Field wiring
  • Field plumbing
  • Debug and troubleshooting of automated machinery


Posted: June 12, 2018, 6:24 am
Category : Mechanical Engineer
Job Type : Permanent
Id : 7372
Region : Twin Cities

Seeking a Senior Mechanical Engineer to be part a team of engineers that develop and support precision, high speed, automated fluid dispensing applicators. Responsibilities include designing and reviewing mechanisms based on piezoelectric, pneumatic, voice coil, cam, flexure and magnetic technology. Emphasis is placed on design and testing methods that assure 24/7 reliability when operated by equipment operators located around the world. In addition, this job involves generating specifications for new products, electronic packaging, thermal design and technical support. Occasional international and domestic travel may be required.

Essential Duties

  • Perform Engineering tasks in the development of new products and cost reduction.
  • Participate in development of Product Specification
  • Produce conceptual designs
  • Create detailed design drawings
  • Provide analysis of design to applicable standards
  • Review instruction manuals and product literature
  • Define and lead prototype development and lab and field tests
  • Work with manufacturing on process development
  • Conduct design reviews, safety reviews, etc.
  • Work effectively in a team environment
  • Provide periodic oral and written reports of project status
  • Troubleshooting product problems in manufacturing, lab, or customer sites

Minimum Qualifications

  • Bachelor’s Degree in Mechanical Engineering
  • Experience with solid modeling systems and mechanical devices
  • 10 years of experience in new product development with demonstrated repeated success producing innovative and successful products

Desired Qualifications

  • Master’s Degree in Mechanical Engineering
  • Five years of experience with fluid dispensing applicators and design
  • Five years of experience with magnetic and piezo-actuated mechanical design


Posted: May 22, 2018, 10:02 am
Category : Manufacturing Engineer
Job Type : Permanent
Id : 7365
Region : Twin Cities

Seeking a PCB Manufacturing Process Engineer to be responsible for defining, developing, and implementing production processes, including workflow, routing, time standards, defining quality metrics and leading process improvement efforts. This position assigns tasks to and directs technical staff and interns on processes and projects. Also, leads complex projects.

 

Duties and Responsibilities:

  • Apply knowledge of electronic assembly processes, Company's production capabilities and Lean manufacturing concepts to develop and implement accurate, achievable and competitive production processes. Provide guidance and training to engineers, technicians, interns and staff on these processes. Actively pursues state-of-the-art knowledge and applies it in these efforts.
  • Establishing and improving production capacity, productivity, and quality. Establish appropriate process controls and metrics.
  • Develop manufacturing documentation, such as process specifications, work instructions, test procedures, and inspection methodology for new PCB and small mechanical assembly processes. Ensure timely documentation maintenance and updates to support new revisions and changes.
  • Develop and Implement Production process development and continual improvement projects. Tasks include appropriate investigations, cost analysis and justifications, equipment selection and installation, purchasing, process validation, installation, and documentation. Develops suitable designs of experiments, budgets and schedules to support these projects. Provides suitable reports and presentations.
  • Develop and provide training to production personnel during new technology transfer.
  • Support production and customers by resolving issues and problems. Drive continuous improvement, perform root cause analysis and ensure issue resolution is effective.
  • Communicate and coordinate within the Engineering department and with Account Managers, Quality personnel, Materials, and Production to ensure quality of product and services.
  • Leads engineering efforts to resolve issues and provide cross-functional solutions to meet customer needs.
  • Communicates and resolves issues with customers, officials and contractors. Acts as company engineering representative at associated meetings.
  • Perform mechanical design and floor layout in CAD. Leads efforts to implement these designs and facility updates
  • Leads efforts to support our Quality Management System (QMS).
  • Incorporate and apply Lean Manufacturing concepts in all job functions

 

Qualifications:

  • 4-year Bachelor of Science in Engineering or closely related field such as physics.
  • Excellent interpersonal and communication skills, both written and verbal.
  • Broad understanding of electronics manufacturing and processes.
  • Experience with Lean Manufacturing concepts and implementation.
  • Ability to interpret a written or oral instructions and documents furnished in diagrams, CAD files, drawings, and/or other forms.
  • Ability to multi-task and set tasks to maintain a schedule.
  • High Aptitude, level of attention to detail, energy, and good analytical skills.
  • 5+ years of related experience in related manufacturing environment.
  • Develops and leads complex projects, manages project schedules and leads engineering and cross-functional teams.
  • Working knowledge of Word, Excel, and CAD required. Experience with MRP/ERP systems, especially Epicor software, preferred. AEGIS software experience preferred.

 

Posted: May 16, 2018, 1:32 pm
Category : Controls Engineer
Job Type : Permanent
Id : 7363
Region : Twin Cities

Seeking an Advanced Controls Engineer - Systems Engineer for control system design and application of various technologies. Technologies include multi-axis motion control, image processing, vision-guided robotics, and industrial instrumentation & automatic control. Candidate will have the ability to provide technical direction in a team-oriented work environment, interface with customers on technical projects, design electrical controls, program PC/PLC/motion/vision, and startup/commission machine control systems.

Ideal candidate will have strong electromechanical aptitude, software development experience, and will have experience in the application of motion control, robotics, PLC/PC programming, HMI”s,and/or vision applications to accomplish customer requirements. Familiarity with programming Adept, Allen-Bradley, VB, and/or Cognex/DVT a plus. In addition, solid organizational skills, a demonstrated ability to own and drive projects to completion, along with a strong desire to work in a fast-paced, entrepreneurial environment is required.

Qualified candidate will have a BS or MS in Mechanical or Electrical Engineering, Computer Engineering, or Computer Science with a minimum GPA of 3.0. 2-6 years of relevant experience is highly desired.




Posted: May 16, 2018, 6:50 am
Category : Engineer/Physics
Job Type : Contract-to-Hire
Id : 7360
Region : Twin Cities

Seeking an Optics Engineer to model, design, and test optics components for company products. This position will also generate and update quality documentation such as requirements, test protocols and reports, justifications, and specifications.

Experience:

  • 5 years industry experience, preferably in medical diagnostics
  • M.S. or higher in Photonics, optics design, or related field

Additional Requirements:

  • Optical scatter and fluorescence flow cytometry
  • Imaging
  • Spectrophotometry
  • Hematology
  • Optics modeling and CAD software tools


Posted: May 9, 2018, 7:27 am
Category : Electrical Designer
Job Type : Contract-to-Hire
Id : 7355
Region : Twin Cities

Seeking an AutoCAD Controls Designer to perform the following:

  • Mechanical layouts of control panels
  • Electrical wiring schematics
  • Communication networks drawings
  • Pneumatic diagrams
  • Piping & Instrumentation Drawings
  • Power Drawings
  • MCC layouts and drawings
  • Experience with AutoCAD is required
  • AutoCAD Electrical experience is a plus

 

Posted: May 1, 2018, 6:52 am
Category : Technician - Medical Equipment
Job Type : Contract
Id : 7354
Region : Twin Cities

Seeking a Senior Engineering Technician for the following duties:

  • Lead E-techs; able to direct, organize, and “own the build process”
  • Assign specific tasks for yourself and other technicians daily
  • Maintain build schedule, working directly with the project manager and designers to overcome obstacles
  • High complexity wiring and mechanical assembly
  • High level troubleshooting and machine “power up” ability
  • Low level I/O checkout, basic end of line mechanical alignments
  • Assist in design suggestions and responsibility for implementation in the build
  • “Ownership” of the print package; Ensure redlines are captured, authorize and/or perform minor modifications
  • Limited field service duties
  • AAS


Posted: April 30, 2018, 1:10 pm
Category : Software Engineer
Job Type : Contract
Id : 7350
Region : Twin Cities

Looking for a LabVIEW Developer 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.

Requirements:

  • Deliver production-ready 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
  • 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, PLCs, VFDs, limit switches.
  • Travel to customer sites for design reviews, site surveys, and system commissioning. Travel is both domestic and international
  • Support or perform system assembly, checkout, and site installation

Qualifications/Education:

  • Bachelor’s degree in Engineering
  • 2 to 5 years of relevant experience implementing automation systems using LabVIEW
  • 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: April 27, 2018, 8:20 am
Category : Technician - Medical Equipment
Job Type : Contract
Id : 7348
Region : Twin Cities

Immediate opportunity for an Automation Build 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: April 26, 2018, 7:17 am
Category : Software Test Engineer
Job Type : Permanent
Id : 7320
Region : Twin Cities

Seeking an experienced, high caliber Senior Systems Verification Engineer to join our System Verification team for development projects within the organization. This candidate will bring testing and leadership expertise to the verification of medical device systems. Responsibilities include requirements analysis, test design, test execution, defect issue resolution, project leadership, and support of the engineering team’s investigation of field complaints.

Position Responsibilities:

  • Design test suites for new product features and functionality
  • Lead product testing projects including estimation, planning, coordination, project deliverables, and directing the day to day tasks of others
  • Work independently and as a team member to plan, write, and execute test cases
  • Participate in the requirements, hazard analysis, and design reviews for new features
  • Display initiative, leadership and coaching skills including continuous quality/engineering process improvement, project leadership, and team training
  • Evaluate, recommend, and employ system tests tools to ensure system quality
  • Provide verification and validation perspective to R&D’s ongoing product development, requirements, product and test designs, defect reviews, user workflows, and field complaint investigations
  • Maintain expert status and continuing proficiency in the field of system test engineering

Position Requirements:

  • Bachelor of Science in engineering
  • Minimum of five years of relevant work experience including system-level test development
  • Understanding of hardware-software systems, requirements leveling, and interface requirements
  • Experience working in the medical device industry or other highly regulated industry
  • Demonstrated ability to develop new methods for characterization of system performance and verification of system functionality
  • Demonstrated ability to understand and comply with applicable FDA regulations and Company operating procedures, processes, policies and tasks
  • Ability to work in a highly matrixed and geographically diverse business environment
  • Ability to work within a cross-functional team and as an individual contributor in a fast-paced, changing environment
  • Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization
  • Strong organizational and follow-up skills, as well as attention to detail

Preferred Qualifications:

  • Master of Science or equivalent in Systems Engineering, Electrical Engineering, Computer Science, Computer Engineering
  • Current industry knowledge of electrophysiology and/or cardiac rhythm management products
  • Experience with LabVIEW, C++, Perl, and Python programming languages



Posted: April 2, 2018, 1:34 pm
Category : Technician - Medical Equipment
Job Type : Contract
Id : 7319
Region : Twin Cities

Immediate opportunity for an Equipment / Controls Automation Technician to support design, start-up, troubleshooting, and validation of automated equipment for medical device product manufacturing. This position will support Controls Engineers in machine design development, including Autocad Electrical design and documentation of control panels, schematics, and mechanical components, updating / programming PLC and HMI software, support repeat equipment builds, and troubleshooting and solving hardware and software (PLC, HMI, Vision) issues.

Requirements include:

  • 2 year Electrical / Automation Tech degree, with
  • Training and experience in design, programming, and troubleshooting of industrial control systems.
  • Requires proficiency with Autocad Electrical Cad, and training in troubleshooting PLC and HMI systems, robotics, machine vision, and controls instrumentation.
  • Will consider entry level candidate with solid training in automated systems, or technician with up to several years of experience.


Posted: April 2, 2018, 8:52 am
Category : Quality Engineering
Job Type : Contract
Id : 7315
Region : Twin Cities

The Senior Quality Engineer - Pharma will provide quality assurance expertise for the development, site transfer, manufacturing and testing of combination medical device/drug products.

This role will provide quality engineering support in sterilization management, environmental control, and cGMP pharmaceutical manufacturing of combination products including analytical lab activities. Provide support to internal and external customers, perform root cause analysis and implement corrective action. May manage projects for new or revised products or quality system changes in cGMP pharmaceutical requirement of combination products. Provides coaching on cGMP regulations and all relevant standards to Quality and Manufacturing Engineering staff. to staff.

 

POSITION RESPONSIBILITIES:

  • Leads Quality System (QS) development for compliance to drug cGMP manufacturing (FDA 21 CFR Parts 210 & 211)
  • Guides, supports and approves development of facilities, utilities, cleanroom, equipment, production processes and controls, cleaning, inspection and testing and batch records for device and combination product.
  • Provides expertise in all aspects of QA: cGMP, pharmaceutical manufacturing, API handling and controls, clean room environments and environmental controls, sterilization, supply chain quality, contamination control, QC unit responsibilities, etc.
  • Develops training programs as needed in areas such as use of equipment, inspection methods, statistical methods, processes, sterilization, environmental controls, quality system etc. to maintain required level of knowledge in cGMP regulations.
  • Approves validation protocols and reports, including but limited to those associated with drug or combination product manufacture, laboratory activity/analytical methods, cleaning validation, and master validation plans.
  • Approves and conducts supply chain evaluations, audits, and approvals including, but not limited to: sterilization facilities, API manufacturers, processing facilities, analytical labs, controlled environment services, etc.
  • Performs internal quality system audits, including establishing audit plans and writing audit reports, and ensure compliance to drug cGMP manufacturing (FDA 21 CFR Parts 210 & 211)
  • Responsible for annual product reviews of all combinations products manufactured
  • Responsible for managing API, materials and product retains.
  • Leads and/or Support all notified bodies and regulatory audits at the site
  • Performs investigations, determines disposition of returned goods, determines reinspection requirements, determines corrective and preventive actions, issues complaint reports, completes customer corrective and preventative actions (CAPAs)
  • Develops project plans and schedules to lead medium to large size projects with definable objectives and due dates.

 

REQUIREMENTS:

  • Bachelor's degree in Science or Engineering or any relevant technical degree, or equivalent experience.
  • 10 plus years of pharmaceutical or combination product manufacturing industry experience,
  • Comprehensive understanding of drug cGMPs and ICH Q7.
  • Comprehensive understanding of drug GMP facilities, utilities and cleanroom requirements particularly for potent compound APIs.
  • Comprehensive understanding of analytical laboratory testing.
  • Strong written and verbal communication skills in the English language.
  • Comprehensive understanding of applicable Work Instructions, SOPs, and ISO standards.
  • Working knowledge of statistical methods associated with six sigma and quality control
  • Effective project leader. & experience with lean manufacturing principles and their implementation.
  • Ability to maintain a professional and respectful relationship with coworkers and company

 

Posted: March 29, 2018, 2:09 pm
Category : Controls Engineer
Job Type : Contract
Id : 7297
Region : Twin Cities

 

Seeking a 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.

 

Requirements:

  • Bachelor of Science (CS or EE)
  • Manager is open to all levels 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: March 15, 2018, 12:25 pm
Category : Mechanical Designer
Job Type : Contract-to-Hire
Id : 7289
Region : Twin Cities

Looking for a Principal Designer to be responsible for performing conceptual design work for new products as well as proposing improvements to existing components. Works independently and creatively to solve problems and create solutions for tasks assigned. Works closely with engineering to accurately assess the performance of proposed concepts and designs. Works directly with customers and medical advisors to develop new products. Works with suppliers to ensure the products manufacturability, and to develop robust methods of inspection.

Essential Duties and Responsibilities:

  • Create designs for new devices, or improvements to existing products from rough sketches, written or verbal design input specifications.
  • Communicate design status and requirements to engineering and program management.
  • Contribute to identifying engineering requirements. Ensure feasibility and performance is assessed by leveraging engineering resources.
  • Participate in design related discussions with a range of internal and external customers, including medical advisors.
  • Specify and analyze tolerances and fits to ensure safe and effective function of devices.
  • Create solid models, drawings and assemblies that comply with applicable standards.
  • Work with suppliers and Quality Assurance to develop measurement techniques that are accurate and repeatable.
  • Propose and evaluate design changes to existing products.
  • Create and process change orders.
  • Manage prototyping and debugging efforts.
  • Contribute to design and project review meetings.
  • Supports Company’s corporative initiative for Continuous Improvement “FOCUS” by promoting the relentless pursuit of eliminating waste, participating in process improvement, and showing the courage to take action and advocate change.
  • Observes safety and security procedures, including maintaining confidentially, using equipment / materials properly, reporting potentially unsafe conditions, and acting upon appropriate actions.
  • Supports Company’s policies and procedures and conducts departmental and Company activities in accordance with these policies.
  • To perform the job successfully, an individual should demonstrate the following competencies: Adaptability, Cooperation, Dependability, Customer Service, Effective Communication, Problem Solving

Minimum Qualifications

  • Associate's degree (A. A.) or equivalent from two-year college or technical school.
  • Eight to ten years’ experience with implantable medical devices, solid modeling, and drafting.
  • Must be familiar with molding plastic components, CNC machining techniques, rapid prototyping methods and measurement of components.
  • Ability to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents.
  • Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community.
  • Ability to write speeches and articles for publication that conform to prescribed style and format.
  • Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry and trigonometry.
  • Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations. Ability to define problems, collect data, establish facts, and draw valid conclusions.
  • Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
  • Must be an expert in CAD skills for creating solid models, dimensioning and tolerancing of drawings to ensure proper fit and fabrication.


Posted: March 1, 2018, 12:50 pm
Category : Electrical Power & Lighting
Job Type : Permanent
Id : 7122
Region : Twin Cities

Qualifications / Requirements:

  • BSEE with a minimum 5 years of engineering design experience
  • Must have a Minnesota PE in electrical engineering
  • Specify and design the installation of medium voltage, relaying, low voltage switchgear and motor control equipment
  • Must have a minimum 2 years’ experience in power system engineering analysis using SKM software
  • Good working knowledge of the current National Electrical Code
  • Capable of producing and supervising the production of industrial electrical construction drawings, specifications, and other documents
  • Proven communication skills and the ability to supervise project teams are required along with the ability to work closely with clients and teams from other disciplines
  • Ability to travel from time to time as needed

Responsibilities:

  • Apply the company’s engineering principle to complete engineering designs associated with the capital projects
  • Technical and execution activities will be performed including system studies, specifying hardware, calculations, preparing and performing project estimates, scheduled, effort-hours, and material forecasts to ensure consistency with engineering standards and operating principles.
  • Perform plant Short-Circuit, LV/MV Coordination and Arc Flash studies using the SKM power tools software.
  • Lead the marketing of power system engineering analysis efforts to internal / external clients
  • Supervision of project teams will be required


Posted: October 25, 2017, 8:06 am
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