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Development Resource Group

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Category : Test Engr - Technical
Job Type : Permanent
Id : 7667
Region : Twin Cities

Seeking a Manufacturing Test Engineer to be accountable for the design installation, qualification and support of manufacturing test systems to ensure the quality of the products manufactured.

Essential Job Functions & Responsibilities:

  • Develop and maintain production test processes and equipment for products produced.
  • Support the production testing of electronic assemblies.
  • Participate in design teams to ensure the manufacturability and quality of products designed.
  • Create and maintain necessary documentation for product specifications and testing.
  • Work with equipment and service vendors to ensure the application of effective test practices at vendor locations.
  • Ensures manufacturing system and subsystem process and parts meet design specifications when products are shipped.
  • Facilitates quality improvement in the quality of test, in manufacturing processes, supplier parts and design.
  • Ensures application of test repeatability and reproducibility standards to new and existing testing of products.
  • Serve as key customer contact on test/quality issues.
  • Uses RMA and Mfg test data to drive product improvement.

Requirements:

  • Engineering and/or Associates Degree in a technical field or related years of work experience: 9-12 years with A.S., 2-5 years with B.S., 0-3 years with M.S.
  • Experience in test engineering or equivalent role required, prior experience in electronic products, Wi-Fi, cellular or satellite communications preferred.
  • Demonstrated project management skills
  • Excellent verbal and written communication skills
  • Excellent customer service and relationship building skills
  • Intermediate/Advanced knowledge of PC and Microsoft Office applications
  • Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations.
  • Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis.
  • Experience developing test applications using LabView; Certified Labview Developer prefered. TestStand desired


Posted: May 23, 2019, 9:11 am
Category : Reliability Engineer
Job Type : Contract
Id : 7666
Region : Twin Cities

We are looking for a dynamic and adaptive Reliability Engineer with the desire to be part of proving and improving implantable medical products and leads, helping to ensure they exceed the safety and reliability requirements and expectations of patients, clinicians, regulators, and the business.

As an integral member of project teams, working in collaboration with functional and cross-functional partners, you will be responsible for planning and leading product safety and reliability technical assessments and compliance activities to ensure that reliability and safety is proactively designed into our products, that potential risks are analyzed and controlled, and that product/system performance is quantifiably predicted. Your work will span the product development lifecycle from research & technology, through development and early market release of new and derivative products.

We are looking for an experienced Quality/Reliability Engineer who can immediately begin contributing to projects. Your work will support the pre-market product development process through development and market release of new and derivative products, ensuring on-time, regulatory-compliant, and highest-quality life-saving medical devices reach patients. The primary focus will be on implantable cardiac devices and leads.

As a Reliability Engineer, you will:

  • Guide and contribute to the successful completion of major projects/programs
  • Represent the organization as a prime technical contact and cross-functional advocate
  • Plan, lead, execute, and integrate Risk Management activities, to demonstrate product safety
  • Plan, lead, execute, and integrate Design for Reliability (DfR) activities, to quantify product reliability
  • Plan, lead, execute, and integrate test and assessment activities, to demonstrate product performance and compliance
  • Apply statistical methods for analyzing data
  • Advocate for Quality in design reviews and other project meetings
  • Participate in preparing clinical evidence to demonstrate sufficient benefits to justify product risks
  • Develop and implement technical analyses, methods, and procedures, to drive product safety, reliability, and quality
  • Advance expert knowledge in applicable standards, requirements, specifications, and required quality and reliability practices in assigned area
  • Participate in interpreting US and foreign governmental regulations, agency guidelines, and internal/corporate policies to ensure compliance is maintained
  • Ensure adherence to the business Quality Management System through procedure compliance and internal audits
  • Perform engineering reviews of quality records for compliance with stated requirements and impact on safety.

POSITION REQUIREMENTS:

  • Bachelor’s Degree in Engineering, Science, or other Technical Discipline
  • 5+ years (with Bachelors) OR 3+ years (with Masters) of industry experience in Engineering, Science, or other technical discipline
  • Experience working on multi-disciplinary teams
  • Fluent in English (both oral & written)
  • Proficient in word processing, spreadsheets, and managing electronic data files

PREFERRED QUALIFICATIONS:

  • Advanced degree in Engineering or Science
  • Degree in Reliability Engineering, Mechanical Engineering, Biomedical Engineering, or Physics
  • Experience in Safety Engineering, Reliability Engineering, Systems Engineering, Product Development Engineering, Clinical, or Field Support
  • Proven understanding of reliability engineering principles
  • Ability to comprehensively apply degree-specific engineering principles in the design of highly reliable, complex systems
  • Strong understanding of and experience in the application of statistics, including experience with Minitab
  • Experience in a highly-regulated industry, preferably implantable medical devices
  • Understanding of implanted medical systems, products, therapies, and their use in the clinical environment, including customer expectations, common medical practice, and systems troubleshooting
  • Knowledge of cardiac anatomy, physiology, and primary disease states
  • Experience with 21 CFR Part 820 (Quality System Regulation), ISO 13485, etc.
  • Experience interpreting and applying industry standards (EN 45502/ISO 14708, IEC 60601, etc.)
  • Experience in the application of Risk Management (ISO 14971) and hazard analysis and risk analysis techniques (e.g., PHA, HA, FTA, DFMEA)
  • Ability to independently lead investigations to identify system/product failures, hazards, hazardous situations, and harms
  • Exposure to or experience working in or with Design, Quality, Regulatory, Clinical and/or Manufacturing
  • Knowledge of Design for Reliability (DfR), Design for Reliability and Manufacturability (DRM), Design for Six Sigma


Posted: May 22, 2019, 12:56 pm
Category : Electrical Engineer
Job Type : Contract-to-Hire
Id : 7665
Region : Twin Cities

Seeking a Principal Electrical Engineer for design and development of medical electronics.  Individuals interested in this position should be able to demonstrate the ability to be the technical lead on a project team involving electronics.

 

Qualifications:

  • BS in Electrical Engineering.
  • 7+ years related experience in electronic instrumentation development with particular emphasis on electrical design and firmware development.
  • Good oral and written communication skills.
  • Experience in a medical product design environment or similar highly regulated field.
  • Experience using Altium and schematic capture and layout.
  • Electrical design experience with 8, 16, and 32-bit micro-controllers/microprocessors.
  • Analog electrical design experience with an emphasis on biological signals.
  • Electrical design of circuitry for signal acquisition, storage, and processing.
  • Creation of requirements, specifications and test protocols.
  • Understanding of IEC 60601 electrical standard.
  • The ideal candidate would also have firmware experience with C in an embedded environment.

 

Responsibilities:

  • Ability to create system/electrical/software requirements for medical product design.
  • Analog and digital design and documentation of electronics for medical products.
  • Design and documentation of embedded electronics and software for medical products.


Posted: May 22, 2019, 12:29 pm
Category : Mechanical Engineer
Job Type : Contract
Id : 7664
Region : Twin Cities

Seeking an R&D Engineer who will support manufacturing processes for medical implant and medical external cable assemblies with primary focus on injection molding and soldering of cables to connectors. This position will design and develop manufacturing processes, tooling, and fixtures in order to meet daily production schedules while enhancing productivity and product quality.

POSITION DESCRIPTION:

  • Engineer with work on cardiac occluders and associated delivery system - remediation and continuous improvement activities
  • Perform, summarize and present research to assist the team in meeting project requirements
  • Participate in or lead problem-solving investigations
  • Develop or improve test methods utilizing skill sets including mechanical design, prototyping, problem solving and measurement systems analysis
  • Work with cross-functional teams to establish the device lifetime for each product
  • Support materials compliance teams with BOM, identification and verification of patient contacting and invasive component list
  • Updates to DHF, design inputs/outputs and product specification as applicable (from detailed gap assessment)
  • Update CAD files, design prints as necessary (materials compliance)
  • Support design quality engineers with risk management updates (frequency of occurrence and assessment of risks)
  • Ensure biocompatibility documentation is complete, update as necessary with shared biocompatibility services
  • Execute V&V work (to current standards as applicable)
  • Support inputs for General Safety and Performance Requirements (GSPR)

POSITION REQUIREMENTS:

  • Intermediate or senior level engineer with 3-7 years’ experience
  • Familiar with design controls and implantable devices
  • Continuous improvement / sustaining engineering experience
  • Previous work on U.S. class II or class III devices, class III preferred
  • Design assurance / development quality experience a plus
  • Experience working with nitinol a plus
  • Experience working with mechanical devices a plus
  • Working knowledge of the E.U. medical device regulation a plus


Posted: May 21, 2019, 2:29 pm
Category : Manufacturing Engineer
Job Type : Contract
Id : 7663
Region : Twin Cities

The Engineering Director - Operations is responsible for evaluating, improving, and controlling the overall performance of manufacturing areas that provide implantable components to finished devices. This Engineering Director interacts closely with cross-functional teams to meet our customers' expectations by striving without reserve for the greatest possible reliability and quality in our products, processes, and systems by being accountable, having a voice, and taking action.

 

A Day in the Life:

  • Establishes operational plans for company that will have a long-range impact on results.
  • Resolves problems that span a wide range of difficult and unique issues across functions.
  • Interacts with internal and external customers and vendors at various levels, including executive leadership, on significant issues.
  • Manage large, complex initiatives of strategic importance to the organization involving large cross-functional teams.
  • Accountable for identifying and implementing GMP (good mfg practices) that apply to specific production area(s)
  • Provide training as needed to ensure production team understands and follow GMP
  • Owns CAPA Task (corrective and preventative actions) to resolve production and customer issues.
  • Leads failure analysis and issue resolution activities to ensure preventative action is accomplished.
  • Identify process improvement opportunities and provide technical solutions via analysis and hands-on interaction with designated processes, including troubleshooting of mfg issues when they occur.
  • Utilize project mgmt skills to drive continuous improvement initiatives to optimize yield, quality, cycle time and/or ergonomics.
  • Evaluate and provide input to mfg lines being released to production to help ensure the introduction of a capable and efficient operation.

 

Required:

  • Bachelor of Science in Engineering and 5-7 years relevant experience or an advanced degree with a minimum of 3 -5 years of experience.
  • Understanding and wide application of technical principles, theories, and concepts of manufacturing processes
  • Engineering supervisory experience
  • Technical knowledge of manufacturing processes


Posted: May 21, 2019, 1:33 pm
Category : Quality/Regulatory
Job Type : Contract
Id : 7661
Region : Twin Cities

Seeking a Materials Engineer to support product and materials development for new and released medical device products, ensuring product safety and reliability through the direction and execution of characterization testing. This will include providing problem solving, materials laboratory testing and data analysis in support of new and existing implantable biomedical devices and systems. Biocompatibility and biostabiltiy testing, as well as documenting product equivalence through appropriate characterization testing will also be included.

This position will provide materials engineering support to document product compliance with international biocompatibility and hazardous substances standards, supporting regulatory submission. Primary areas of focus include testing for and documenting compliance relating to REACH, RoHS and other regional standards for medical devices. This includes interpretation of standards, interfacing with suppliers for supporting documentation and directing applicable testing to address gaps when necessary.

This person will work under general supervision, solving technical problems  with an emphasis on polymer materials, materials analysis, testing and microscopy.

 

POSITION RESPONSIBILITIES:

  • Guide product development and remediation through the familiarity of international device regulations pertaining to medical devices and Materials of Concern, including RoHS and the European Union Medical Device Directive.
  • Conduct laboratory testing and write technical reports to document device/component compliance with necessary regulations and materials characterization requirements.
  • Work in a regulated environment.
  • Support regulatory submissions with technical rationales/documentation on an as needed basis.
  • Communicate results and strategies via detailed technical documents and presentations.
  • Support the quality and reliability of released product through comparative testing or root cause characterization testing.
  • Participate in the analysis of technical issues and the development of recommendations for project decisions and actions

 

POSITION REQUIREMENTS:

  • Bachelor's degree in materials, chemical, biomedical or mechanical engineering and 5 years experience
  • Materials Science knowledge with an emphasis on polymer materials testing, processing and analysis.
  • Knowledge of international standards, testing and regulatory requirements.
  • Knowledge of Microsoft applications (Excel, Word, Outlook).
  • Experience in a regulated environment.
  • Experience interfacing with suppliers to document regulatory compliance.

 

DESIRED QUALIFICATIONS:

  • Experience in polymer characterization techniques including FTIR, DMA, DSC, TGA and chemical degradation tests.
  • Regional experience in medical devices and regulations such as European Union.
  • Experience developing a medical device, including materials characterization, biocompatibility and biostability.
  • Problem solving skills to identify root cause of materials related issues and ability to recommend mitigation strategies.
  • Experience in regulatory and device regulations for medical devices including biocompatibility and regulated materials.

 

Posted: May 20, 2019, 7:08 am
Category : Chemical Engineer
Job Type : Contract
Id : 7662
Region : Twin Cities

The Materials Engineer will assist in developing materials technology solutions for component and device level designs for implantable products. This includes support of both new product development and continuity of existing electrical stimulation and infusion products, when materials grade/vendor/processing changes are warranted or when submitting these products to regulatory agencies.

This individual works under general supervision to apply technical expertise to diverse technical problems. Particular emphasis will be on applying Materials Science knowledge to products that directly or indirectly contact patients. This individual will collaborate with project leaders to solve challenging technical problems and will lead materials efforts through various phases of the product lifecycle including product development and support of commercial products.

POSITION RESPONSIBILITIES:

  • Develop solutions for technical problems related to materials used in neurostimulators, implantable infusion systems and their components and delivery tools. Create engineering evidence for solutions capable of meeting the established requirements.
  • Support assessment and optimization of biostability of materials and material/drug compatibility by understanding influences of processing conditions and biological/chemical environment on materials.
  • Support product continuity by evaluating material grade/vendor/processing changes.
  • Support preparation or review of regulatory submission-ready documentation for the FDA and other regulatory bodies.
  • Interact professionally with immediate supervisor, project leaders and other professionals in the group. Comply with applicable corporate and departmental policies.
  • Proactively manage deliverables and provide regular updates to professional staff, project and functional management.
  • Support and comply with quality system requirements. This includes Materials deliverables, as well as formal technical, lab and business procedures and remaining current on training requirements.

POSITION QUALIFICATIONS:

  • Bachelor’s degree in Materials Science, Metallurgy, Chemical Engineering or Polymer Science with at least 2 years of experience, or Master’s degree in Materials Science, Metallurgy, Chemical Engineering or Polymer Science

PREFERRED QUALIFICATIONS:

  • Excellent report-writing and verbal English communication skills
  • Strong interpersonal and team skills
  • Experience in the medical device or other regulated industry
  • Understanding of materials testing methods and characterization techniques
  • Ability to work effectively within a team environment


Posted: May 20, 2019, 7:08 am
Category : Technician - Medical Equipment
Job Type : Contract
Id : 7660
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: May 15, 2019, 1:23 pm
Category : Quality Engineering
Job Type : Contract
Id : 7659
Region : Twin Cities

Seeking a Quality Engineer to be the lead engineer as part of a team to review current manufacturing controls for parts in scope and determine if the appropriate levels of controls are in place and to ensure the correct parts are consumed by downstream processes. Parts in scope are part numbers which share processing responsibilities between two Value Streams/ Facilities for a singular consumption of a component. As applicable, establish applying a cleaning specification to components as a Process Output Requirement. Where deficiencies are detected, implement controls to ensure all DMR activities are completed. Records and processes to be reviewed include:

  • pFMEAs
  • FactoryWORKS Process Flows
  • Incoming Inspection Plans
  • SAP Work Flows

Evaluation will result in documented justification for no action, or identification of needed improvement activities to ensure parts are received and/or consumed in a cleaned state. This position Requires a University Degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.



Posted: May 15, 2019, 8:40 am
Category : Mechanical Engineer
Job Type : Contract
Id : 7657
Region : Twin Cities

Looking for a Mechanical Engineer to design medical devices to comply with industry methodologies and standards.  This candidate will define requirements, technologies, and methodologies for individual projects.  Research and analyze data such as experimental data, customer design proposals, specifications, and documentation.  Direct and coordinate actions from product conception through design transfer to ensure products and systems conform to engineering design, standards and customer specifications.  Resolve technical issues and problems.  Effectively communicate their work and status.  Delegate work and leverage engineering technicians and designers.

 

Essential Duties and Responsibilities

  • Applies principles of mechanics, thermodynamics, hydraulics, heat transfer, and materials.
  • Designs medical products and confirms correctness using methodologies and tools such as FEA, GD&T, CFD, etc.
  • Evaluates mechanical and electromechanical systems and products by designing and conducting research programs.
  • Leads and completes medical standard document deliverables.
  • Identifies and efficiently resolves technical problems and issues.
  • Leads and communicates to a client for small scale programs.
  • Researches and analyzes experimental data to understand design issues and set a direction for issue resolution.
  • Prepares product reports by collecting, analyzing, and summarizing information and trends.
  • Delegates and sets work direction for technicians and designers.
  • Works with suppliers and manufacturing facilities to design for manufacturability.

 

Education/Experience:

  • Bachelor's degree in Mechanical Engineering or equivalent
  • Minimum 3+ years of experience in new product development.
  • Direct experience with the product development process ranging from requirements development, prototyping, verification and product release is required.
  • Experience in medical device design or other regulated industries preferred.
  • Must have demonstrated experience working on electromechanical systems.
  • Prefer experience with IEC 60601-1 and with ISO 14971 Risk Management for Medical Devices.
  • Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. 
  • Ability to write reports, business correspondence, and procedure manuals.
  • Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the public.

 



Posted: May 14, 2019, 11:46 am
Category : Systems Engineer
Job Type : Contract
Id : 7658
Region : Twin Cities

Seeking a Systems Engineer to perform technical planning, system integration, verification and validation, evaluate alternatives including cost and risk, supportability and analyses for total systems. Analyses are performed at all levels of total system product to include: concept, design, fabrication, test, installation, operation, maintenance and disposal.

POSITION RESPONSIBILITIES:

  • Ensures the logical and systematic conversion of product requirements into total systems solutions that acknowledge technical, schedule, and cost constraints.
  • Performs functional analysis, timeline analysis, detail trade studies, requirements allocation and interface definition studies to translate customer requirements into hardware and software specifications.
  • Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results.
  • The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies.

POSITION REQUIREMENTS:

  • Requires a Bachelor’sDegree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.
  • Must be able to work independently under limited supervision to determine and develop approach to solutions.
  • Practical knowledge of project management is a plus.


Posted: May 14, 2019, 7:27 am
Category : Quality Engineering
Job Type : Contract
Id : 7655
Region : Twin Cities

Seeking a Quality Engineer that will be responsible for generating all CAPA Metrics for inclusion in Management Review and ownership of CAPAs. This position will be responsible for analysis of all CAPA Metrics, and providing these results to appropriate Management Review contacts. (Metrics are primarily located in CATSWeb and Grand Avenue- familiarity with both systems is a plus).

Position Responsibilities:

  • Ability to identify trends in data, and communicate the issue through various levels of the organization.
  • Must be proficient at Excel, Powerpoint, Word. High level of attention to detail required.
  • Support decision making and oversight of the quality systems, including CAPA (Corrective and Preventive Action) systems.
  • Support key stakeholders with developing and maintaining QA procedures, forms, and systems.
  • Maintain databases and record storage for QA systems.
  • Process QA requests, ensuring owners are assigned, and timely responses are provided in alignment with quality goals.
  • Participate in meetings and communications for QA system information, concerns, and updates.
  • Seeks out information with direction and able support other members of the organization on QA practices.
  • Support SH CAPA team with training, CAPA oversight, and CAPA deliverables.
  • Support presentation of CAPA System to internal and external auditors

Position Requirements:

  • Technical background - Degree in engineering is not required
  • Experience with Project Management
  • Experience in a regulated industry
  • CAPA experience is required


Posted: May 10, 2019, 2:27 pm
Category : Electrical Engineer
Job Type : Contract
Id : 7656
Region : Twin Cities

Seeking a Product Stewardship Engineer with 2-4 years of experience and technical experience in science or engineering to support the implementation of a product stewardship database, Ensure part, packaging and product information is accurately tracked in database.

Position Responsibilities:

  • Work to Corporate Regulatory/Product Stewardship team and provide updates as needed.
  • Ensure compliance with geography specific restricted substance requirements (e.g., RoHS, REACH, EU MDR) and Restricted Substance Management (RSM) requirements.
  • Facilitate, track and work with various groups on component changes in the manufacture, import and distribution of any new product or relocation of manufacturing processes.
  • Facilitate division compliance with all RSM reporting requirements.
  • Coordinate with R & D support, the implementation and integration of RSM evaluations.
  • Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS) 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.
  • Supports Environmental Management System, ISO 14001 and division sustainability efforts.
  • Performs other related duties and responsibilities, on occasion, as assigned.

Position Requirements:

  • Bachelor’s Degree
  • Must possess critical thinking, problem solving and planning skills.
  • Must use sound judgement and ability to build and maintain relationships with individuals and in teams.
  • Ability to work in a highly matrixed and geographically diverse business environment.
  • Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
  • Ability to leverage and/or engage others to accomplish projects.
  • Medical device manufacturing experience preferred
  • Experience in restricted substance management (e.g., REACH, RoHS) preferred
  • Experience working in a broader enterprise/cross-division business unit model preferred.


Posted: May 10, 2019, 11:24 am
Category : Test Engr - Technical
Job Type : Contract
Id : 7654
Region : Twin Cities

Seeking a Test Method Validation Engineer to work on a cross functional team to conduct test method validations for a medical device transition project.

 

Position Responsibilities:

  • Development of test methods for both standard measurement equipment and product specific methods
  • Carrying out Gauge R&R and Attribute Agreement Analysis studies
  • Utilize statistical evaluation techniques to evaluate test data.
  • Writing protocols & technical reports
  • Review and approve test requests and studies as appropriate

 

Basic Qualifications:

  • Bachelor's degree in Science or Engineering discipline
  • 2-5 years of experience in the medical device industry or highly regulated industry

 

Preferred Qualifications:

  • Working knowledge of Minitab
  • Knowledge in developing test methods
  • Experience in writing test method protocols and validation
  • Experience in technical writing reports
  • Basic understanding and familiarity on test setup
  • Strong communication skills, both oral and written
  • Ability to work independently with minimal supervision


Posted: May 8, 2019, 2:25 pm
Category : Electrical Engineering
Job Type : Contract
Id : 7652
Region : Twin Cities

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

Primary Responsibilities:

  • Create high quality formal documentation and records.
  • Create and implement Engineering Change Requests (ECR) and Engineering Change Orders (ECO) in Company’s Product Data Management system. This includes leading the cross functional change review and approval process.
  • Assess supplier driven changes and Part Change Notifications (PCN) for potential impact against product functional requirements, and document the rationale and/or testing necessary for approval of such notifications.
  • Communicate technical details and achieve the necessary understanding and trust from non-technical audiences.
  • Drive suppliers to provide timely resolution to change implementation and analysis requests.
  • Typical issues are reactive and are often urgent, so priorities change frequently, and issues must be resolved promptly. Some issues requiring resolution may contain a mechanical element as well.
  • Leverage area expertise and learn new design elements to quickly become the design expert as issues require.

Secondary Responsibilities:

  • Create test plans and reports, and coordinate product testing.
  • Design, analyze, and test analog and digital circuits either independently or while working closely with a design technician.
  • Evaluate returned product to determine the root cause of field returns and establish design improvements.
  • Review vendor failure analysis reports for accuracy.
  • Assess the impact of changing regulatory standards on existing medical products, and assess the impact of changes in medical products against existing regulatory standards.

Preferred Qualifications:

  • 5 to 10 years industry experience
  • Experience in the development or support of medical products.
  • Experience working in or with a manufacturing environment.
  • Experience in a regulated industry (e.g. medical, aerospace, military).
  • Experience with quick turn assignments.
  • Proven experience working effectively both independently and with multi-functional teams.


Posted: May 8, 2019, 1:59 pm
Category : Chemical Engineer
Job Type : Contract
Id : 7651
Region : Twin Cities

Seeking a Process 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
  • 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

 

Positon Requirements:

  • Bachelors Degree – Chemical Engineering preferred
  • Experience in polymer formulation, cleaning and coating characterization and validation work
  • 3-7 years experience working in industry with procedures and written reports
  • Individual should be innovative, resourceful, and work with minimal direction
  • Have excellent organization, problem solving, communication, and team leadership skills
  • Work effectively with cross-functional teams


Posted: May 7, 2019, 3:01 pm
Category : Production Manager
Job Type : Permanent
Id : 7650
Region : Twin Cities

Seeking a qualified and cost-conscious Production Manager to lead a busy production team.

 

Duties and Responsibilities include the following:

  • Oversee a workforce of 30+ employees
  • Manage the production plan to assure resources are deployed on a daily basis where needed keeping skill set, experience, and project schedule as key leading indicators
  • Create and oversee an employee training schedule that emphasizes quality, productivity and resource conservation
  • Evaluate manufacturing processes to ensure maximum efficiency
  • Create production metrics which will drive understanding and leading indicators for adjustment
  • Enforce safety policies and procedures (both in-house and regulatory) to decrease the potential for employee injuries on the job. Assume a role on the safety committee as assigned.
  • Assume responsibility for manufacturing, packaging and shipping processes in the plant
  • Inspect equipment prior to shipment to ensure accurate labeling and record keeping
  • Maintain open lines of communication between employees and management
  • Ensure all resources and assets are used efficiently and correctly
  • Assume a project management role on project scope deliverables as assigned and as determined to be complimentary to production and resource management.
  • Deliver to project management standards as assigned.

 

Qualifications:

  • Bachelor's Degree in technical field or equivalent with 7+ years manufacturing supervision experience in a automation environment
  • Ability to create and follow schedules
  • Working knowledge of OSHA and EPA regulations
  • Project management experience is a plus
  • Organization skills and willingness to assume accountability for plant practices required


Posted: May 7, 2019, 11:30 am
Category : Software Test Engineer
Job Type : Contract
Id : 7649
Region : Twin Cities

Seeking a Senior Software Quality Engineer to be responsible for executing and maintaining software quality engineering methodologies and providing quality engineering support for software utilized throughout the company.

Experience:

  • Validating Non-Product Software used on the manufacturing floor
  • Author software validation plans, test protocols, requirements trace matrix, software validation reports
  • Execute software validation plans/test protocols
  • Risk Analysis - performing software risk analysis as part of a team
  • Complying with regulatory guidelines (FDA 21 CFR Part 11) and quality systems (21 CFR Part 820)in a regulated environment - knowledge of compliance to ISO 13485, FDA 21 CFR Part 11 and 21 CFR Part 820

Other:

  • Can work independently with minimal oversite and supervision
  • Quickly and easily gains an understanding of new software
  • Understand the validation required for Firmware, configure SW, custom developed software
  • Performs quality work
  • Compliance to process
  • Good negotiating and coordination skills with other functions (ME, Quality, PD, R & D, etc)
  • Able to work in a fast-paced environment
  • Excellent communication skills
  • Good writing skills/Good Documentation Practices


Posted: May 3, 2019, 11:56 am
Category : Software Test Engineer
Job Type : Contract
Id : 7647
Region : Twin Cities

Seeking a Software Test Automation Engineer to support implementation, enhancements, and modifications to test automation framework, automation tools, emulators, test scripts, and code.

POSITION RESPONSIBILITIES:

  • Develop solutions to solve extremely complex problems in test automation framework.
  • Implement new tools, techniques and processes to reduce test maintenance effort.
  • Implement dynamic solutions to increase code coverage in automation framework.
  • Debugs, troubleshoots, and isolates software problems and offers strategic advice regarding identified issues for future development.
  • Presents at design reviews; documents and resolves issues as directed.
  • Identifies parameters, structure, and critical test components.
  • Writes, updates, or executes test design, cases, as well as procedures and reports results.
  • Evaluates prototypes formally and informally through structured and ad hoc testing.
  • Test aspects of new projects or algorithms to evaluate prototypes and validate output to meet intended use requirements.

POSITION REQUIREMENTS:

  • Bachelor of Science in Computer Science or related engineering field, or equivalent, including relevant coursework and/or work experience in product development.
  • Strong in Python.0 to 3 years of professional software test engineering experience.
  • Knowledge of software development lifecycle management tools.
  • Organized, on-time, quick learner and detailed oriented.
  • Excellent documentation skills


Posted: May 2, 2019, 6:55 am
Category : Quality Engineering
Job Type : Contract
Id : 7641
Region : Twin Cities

Seeking a Design Quality Engineer to provide design quality and reliability support for medical device products, provide engineering expertise on cross-functional teams and collaborate with other internal and external engineering groups on active and sustaining and remediation projects.

 

ESSENTIAL FUNCTIONS:

  • Strong working knowledge of medical device risk management in compliance with 14971:2012 and Design Controls.
  • Strong working knowledge of EU Medical Device Regulations, FDA Guidance Documents and Industry Standards.
  • Lead, coordinate, execute, and document system analysis and design activities, including but not limited to security, safety, reliability, risk, usability and interface management
  •  This candidate will have a strong Quality background and must be able to work in a team environment and be able to communicate clearly across all disciplines including Research & Development, Regulatory Affairs, Manufacturing, Marketing and Outside Partners and Regulatory Agencies.
  • Ensure EHS&S requirements are met during Product Development Process and Sustaining Engineering updates
  • Generate and approve requirements and specifications for all aspects of product concept; ensure that all project documentation is created according to procedures in the quality management system
  • Establish verification and validation plan(s) to ensure requirements are met
  • Apply established SOP's, and/or develop new processes as needed, to ensure that newly developed devices meet established requirements and, where necessary, are approvable under applicable regulatory requirements
  • Assess system performance during the development process and provide feedback to project teams
  • Strong collaboration and influence skills (build relationships, leverage others, align and work towards shared outcome-based goals, understand others' needs, negotiate for win-win)
  • Collect, analyze, and model design inputs (voice of the customer, voice of the business, etc.) and transform them into high quality stakeholder and system requirements
  • Provide engineering review on current research projects, device concepts and data.

 

POSITION REQUIREMENTS:

  • Bachelors degree and 3+ years relevant experience
  • Solid understanding of the risk management process pe ISO 14971: 2012

 

PREFERRED QUALIFICATIONS:

  • Material sciences degree
  • 1+ years of experience with a PhD in a technical/engineering discipline
  • Significant breadth of knowledge in design or development Quality, technical expertise in all areas of product development.
  • Strong working knowledge of risk management, CAPA process, and Design Controls.
  • Strong working knowledge of Medical Device Regulations, FDA Guidance Documents and Industry Standards
  • Knowledge of Electromagnetic Navigation Bronchoscopy (ENB) device operation or other endobronchial procedures/devices
  • Knowledge of FDA regulations and BSI requirements


Posted: April 29, 2019, 10:51 am
Category : Manufacturing Engineer
Job Type : Contract
Id : 7639
Region : Twin Cities

The Manufacturing Engineer is responsible for the project management, planning, and implementation of projects identified during the remediation analysis identifying gaps in current manufacturing verification requirements. This position interacts closely with cross-functional teams including several engineering disciplines such as Process Development, Quality, Reliability Engineering, and Regulatory Affairs. Additionally, this position requires problem solving skills and technical knowledge (Lean, DMAIC) and the ability to manage complex projects to a successful and timely conclusion.

POSITION RESPONSIBILITIES:

  • Utilizes project management skills to ensure timely and effective implementation, including report outs, risk assessments, and cost/benefit analysis
  • Make use of appropriate technical skills and tools, such as gage R&R, DOE, SPC, hypothesis testing, and capability studies to implement required verifications.
  • Manage project through required regulatory approvals
  • Lead teams and collaborate with multiple levels and cross-functional areas for effective project execution
  • Conduct regular project reviews to assure accomplishment of key results.
  • Communicate progress, status, and issues to upper management.

BASIC QUALIFICATIONS:

  • Bachelor of Science in Engineering or related Technical/Scientific field of study
  • Minimum of 2 years manufacturing engineering experience or MS degree
  • Experience in medical manufacturing environment
  • Experience with project management
  • Experience with process control including SPC, DOE, and gage R&Rs
  • Technical knowledge of manufacturing processes
  • Experience handling multiple tasks concurrently
  • Experience interpreting mechanical drawings
  • 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 QUALIFICATIONS:

  • Master’s Degree
  • Green Belt Certification (Internal or ASQ)
  • BB/Master Black Belt certification
  • Experience in Leading large projects and project teams
  • Experience with Medical Device Regulation ISO 13485.
  • Experience in medical product mfg / assembly operations
  • Excellent data analysis skills, and proficient in the use of statistical tools in problem solving


Posted: April 26, 2019, 6:19 am
Category : Electrical Engineer
Job Type : Permanent
Id : 7638
Region : Twin Cities

The primary responsibility for the senior level Certification and Compliance Engineer is to manage and execute the global certification and compliance process for our custom OEM telematics devices and solutions.

 

POSITION RESPONSIBILITIES:

  • Lead certifications across carriers in Americas, Europe, Middle East, Asia and Africa
  • Work closely with 3rd party lab for testing required by carriers
  • Understand carrier standards and work with engineering to ensure compliance
  • Identify and fill gaps in documentation and procedures for certification and product validation.
  • Execute test plans for certifications
  • Develop technical and business relationships within the carrier organizations to be effective
  • Responsible for technical submittals packages to carriers. Ensure documentation is sufficient for successful implementation.

POSITION REQUIREMENTS:

  • 5 years experience in certification and compliance engineering
  • Experience in a customer facing technical role
  • Experience with wireless, cellular, GPS, or Telematics technologies
  • BS in Electrical Engineering, Computer Science, Computer Engineering, or related field of study

Strong Pluses:

  • Solid understanding of safety compliance
  • MS in Electrical Engineering, Computer Science, Computer Engineering, or related field of study


Posted: April 23, 2019, 9:56 am
Category : Software Engineer
Job Type : Contract
Id : 7637
Region : Twin Cities

Join a dynamic and motivated team developing medical products as a Software Developer that set the bar for clinical excellence and efficient workflow. As a member of the software development team you will help take these products to the next level and reduce cost, improve quality, increase access.

Essential Responsibilities:

  • Have familiarity with all aspects of Software Development Life Cycle and methodologies
  • Develop and maintain documentation to identify design, requirements and solutions
  • Write well-designed, testable code
  • Integrate software components into functional software system
  • Troubleshoot, debug and upgrade existing systems
  • Support process improvements which guide the development, sustaining & support activities
  • Drive world-class quality in the development and support of products
  • Communicate effectively both within immediate team and also across the program and business leadership team
  • Leveraging DFR for software and Agile and Lean software development methodologies to drive reliability and predictability throughout the product development life cycle
  • Ensures understanding of issues and presents clear rationale.

Qualifications/Requirements:

  • Bachelor’s Degree in Computer Science or in “STEM” Majors (Science, Technology, Engineering and Math)
  • 4+ years C++ or C#.net in Microsoft Windows development
  • 4+ years of Agile software development
  • Object Oriented Design Experience Desired Characteristics Technology/Process
  • Master’s Degree in Engineering or Computer Science
  • Experience in software development in the medical field
  • Software development tool experience such as Perforce, Jira, Jenkins Leadership
  • Ability to takes ownership of small and medium sized tasks and deliver while mentoring and helping team members
  • Able to speak to mutual needs and win-win solutions. Uses two-way communication to influence outcomes and ongoing results


Posted: April 23, 2019, 6:37 am
Category : Reliability Engineer
Job Type : Contract
Id : 7635
Region : Twin Cities

The Reliability Engineer is expected to have a strong grasp of engineering standards, technical principals, theories, concepts and tools along with general knowledge of other related disciplines. This position will contribute to post market surveillance, risk management and manufacturing/supplier/design change reliability support.

POSITION RESPONSIBILITIES:

  • Understand product function, use environments, and performance to appropriately and strategically apply technical knowledge, reliability tools, and reliability methodologies to assess the impact of proposed reliability enhancements.
  • Perform systematic reliability analysis against requirements, through the appropriate application of reliability engineering and risk management techniques (e.g. FMEA, failure trending and analysis, reliability forecasting, etc.).
  • Reliability and Patient Safety Risk Assessments, including issue triages for CAPAs, reliability predictions, Hazard Analyses, etc.
  • Review and approve manufacturing and design changes and assess their impact in order to ensure reliability requirements are met.
  • Maintain risk management and compliance documentation.

BASIC QUALIFICATIONS:

  • Bachelor’s degree in Engineering or technical field
  • 2+ years experience in medical technology with Bachelor’s; or Master’s degree in Engineering or technical field

PREFERRED QUALIFICATIONS:

  • Proficiency with data analysis using reliability tools and statistical techniques
  • Experience in a highly regulated industry, preferably medical devices
  • Experience with solving complex issues by interacting with cross functional groups
  • Proven ability to operate in a matrix organization and navigate complex business systems, regulations, standards, and performance requirements.
  • Knowledge of reliability tools and practices that effectively support requirements, design, integration and verification, and validation.
  • Demonstrated critical thinking skills with focus on improved system performance outcomes and positive business impact.
  • Demonstrated ability to leverage data and apply knowledge to drive process and product improvement.
  • Excellent problem solving skills, including demonstrated application of structured problem solving methods and tools.
  • Understanding of Left Ventricular Assist Devices (LVAD) and their use in the clinical environment.
  • Reliability engineering experience, including product performance modeling and trending.
  • Knowledge of cardiac anatomy, physiology, primary disease states
  • Strong written and oral communication skills (timely, clear, concise, accurate, conclusive, influential, targeted to audience).
  • Strong collaboration and influence skills (build relationships, leverage others, align and work towards shared outcome-based goals, understand others’ needs, negotiate for win-win, own the whole).
  • Experience working across geographies and cultures.
  • Experience with 21 CFR Part 820 (Quality System Regulation), 21 CFR 803 (Medical Device Reporting), 21 CFR 806 (Corrections/Removals), ISO 13485, etc.
  • Experience with the application Risk Management in medical devices (ISO 14971).
  • Knowledge of project management tools and techniques.
  • Experience working across geographies and cultures.


Posted: April 17, 2019, 11:55 am
Category : Hardware Engineer
Job Type : Permanent
Id : 7634
Region : Twin Cities

Seeking an Industrial Engineer to collect and maintain production metrics and help plan current and future layouts of production facilities. This position will work cross functionally to drive and develop Lean and Six Sigma within our organization. They will also help ensure facility efficiency and workplace safety. This Industrial Engineer will own practices and procedures for developing and sustaining a continuous improvement culture.

Essential Duties and Responsibilities:

  • Analyze and implement manufacturing and/or business process improvements that increase capacity, reduce lead-time, eliminate non-valued added, reduce work in process and improve on time delivery.
  • Leads initiatives that drive continuous improvement culture on site (i.e. Employee Suggestion systems, Lean Training, coaching/mentoring)
  • Champions Lean, Six Sigma and continuous improvement team activities
  • Performs time studies and conducts line balancing activities to drive productivity improvements on production floor
  • Perform capacity analysis, layout planning, and move facilitation
  • Stays current with medical device requirements and maintains technical awareness of new and existing manufacturing processes and trends.
  • Lead, coach, and train employees on Lean and Six Sigma tools and methodologies

Qualifications:

  • Bachelor's degree in an engineering, technical or scientific discipline.
  • 2 to 6 years manufacturing or industrial engineering experience in electronic-based manufacturing environment. Medical device preferred.
  • Demonstrated ability in using and implementing Lean and Six Sigma tools and methodologies
  • Experience with regulated environments such as FDA QSR's, ISO13485 for medical devices and ISO 9001:2000 preferred.
  • Ability to write and edit technical documents
  • Strong interpersonal communication (both written and oral)
  • Strong analytical skills and problem solving ability
  • Proficient knowledge of quality improvement tools and techniques
  • Ability to work independently, but also function as a team
  • Demonstrated proficiency working with computers and the MS Suite


Posted: April 16, 2019, 1:56 pm
Category : Technician - Medical Equipment
Job Type : Contract
Id : 7633
Region : Twin Cities

Seeking an experienced Technician to be responsible for the analysis and repair of external medical devices, in the Service Center, to GMP and ISO requirements. This individual will perform assigned tasks & routine duties using standard practices and work instructions in the area under limited supervision. Technician will use electronic training and knowledge of repair techniques, using standard test equipment and hand tools.

 

Responsibilities:

  • Performs a variety of duties in the electronic, mechanical, electromechanical, and/or optical areas. Constructs, troubleshoots, calibrates, adjusts, tests, diagnoses, and maintains equipment, components, devices, or systems.
  • Works from schematics, engineering drawings and written or verbal instructions.
  • Operates related equipment; conducts tests and reports data in prescribed format. Performs calibration and alignment checks; makes adjustments, modifications, and replacements as directed; prepares prescribed compounds and solutions.
  • Provides technical support in areas such as production, operations, maintenance, safety, testing, process improvement or product development.
  • Uses schematics, diagrams, written and verbal descriptions or defined plans to perform testing and troubleshooting on electronic or mechanical components, equipment or systems.
  • Gathers, maintains, formats, compiles, and manipulates technical data using established formulae and procedures, and performs detailed mathematical calculations.

 

Required Knowledge and Experience:

  • Requires minimum of 4 years of relevant experience
  • 2 Year Degree
  • Medical Device background Preferred


Posted: April 15, 2019, 6:36 am
Category : Test Engr - Technical
Job Type : Permanent
Id : 7626
Region : Twin Cities

Seeking a Senior Software Test Engineer to provide end to end development of TestStand/LabVIEW solutions for custom functional test systems including, writing requirements; test system development and integration; acceptance testing and technical support.

Major Areas of Accountability:

  • Develop software test system requirements
  • Design software solutions that satisfy test system requirements
  • Lead or participate in design review meetings
  • 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
  • Support the sales process by providing technical expertise in customer proposals
  • Provides effective communication with project team members, including project status, risks and suggestions to project leadership
  • Collaborate with customers as needed to accomplish customer goals

Education and Experience:

  • Bachelor’s Degree in Electrical Engineering, Computer Science or equivalent experience in a test engineering environment
  • 5 – 10 years of work experience using TestStand and LabVIEW
  • CLD or CLA is preferred
  • Ability to design TestStand or LabVIEW architectures based on system requirements
  • Application software development skills in Microsoft Visual Studio (VB.NET/C#). C/C++ experience a plus
  • Analyze existing test solution (electrical/software) and understand the design for maintenance or updating/upgrading test software
  • Solid analytical skills; able to resolve technical problems with innovative solutions
  • Proven ability to manage working on multiple projects at a time while paying strict attention to detail
  • Proficiency with Microsoft Office Suite
  • Effective verbal and written communication skills
  • Capacity to deal with a high workload and deadline pressure
  • Requires a strong initiative, proactive nature and a sense of urgency
  • Ability to travel 0% - 10% to client locations for meetings and/or system installations
  • Ability to work extended hours as necessary to meet deadlines
  • Must be able to perform in a team environment with good interpersonal skills with commitment to the highest quality achievable
  • Maintains confidentiality and security of intellectual property (ITAR, Prototype)


Posted: April 4, 2019, 12:07 pm
Category : Mechanical Engineer
Job Type : Permanent
Id : 7625
Region : Twin Cities

Seeking a Mechanical Design Engineer to manage custom electro-mechanical design of semi-automated and automated test equipment projects from design through the in-house manufacturing build process considering costs, time limitations, planning, and other technical factors.

Major Areas of Accountability:

  • Analyzes engineering proposals, process requirements, and related technical data to determine feasibility of product proposal considering costs, time limitation, planning and other technical factors; consults with sales and customers as needed to satisfy customer objectives.
  • Applies engineering principles to develop effective designs for products, associated and subsystems components, and structures which satisfy project requirements and can be produced by existing manufacturing methods.
  • Develops product or system layout and detailed drawings.
  • Facilitate internal and external design reviews.
  • Provides work instructions for manufacturing or building of prototype product or systems.
  • Optimizes design for cost, quality and manufacturability
  • Researches and solves complex technical problems either independently, or by conferring with internal colleagues or consulting with outside experts.
  • Develop and maintain expertise in selected technical areas and act as a resource for others in the group.
  • Provide mentoring and training to Mechanical Design Engineers

Education and Experience:

  • A 4 year college degree in Mechanical Engineering or similar discipline
  • A minimum of five years previous work experience in electrical, mechanical or automation design.
  • Manufacturing Engineering, Manufacturing Design and/or Electro-mechanical manufacturing experience a plus.
  • SolidWorks CSWP Certified
  • Basic electrical (low voltage) knowledge required.
  • Proven ability to manage multiple projects at a time while paying strict attention to detail.
  • Technical competence, including the ability to create engineering drawings and designs using SolidWorks or other 3D design package.
  • Hands-on experience and solid working knowledge of both ERP and PDM/PLM software tools.
  • Solid analytical skills; able to resolve complex technical problems with innovative solutions
  • Effective verbal and written communication skills.
  • Capacity to deal with a high workload and deadline pressure.
  • Proficiency with Microsoft Office Suite.
  • Requires a strong initiative, proactive nature and a sense of urgency.


Posted: April 4, 2019, 12:01 pm
Category : R&D Engineer
Job Type : Contract
Id : 7622
Region : Twin Cities

The Chemical Engineer will participate on an R&D team developing medical devices for treating chronic end-stage kidney disease.  The main purpose of this role is to plan and execute R&D activities to design and develop a sorbent based water purification canister for dialysis therapy in accordance with established quality procedures.

 

Responsibilities:

  • Plan and conduct R&D activities to define requirements for the water purification module, identify and screen sorbent materials and develop prototype cartridges to demonstrate technical feasibility
  • Plan and prioritize project activities, develop a project schedule and execute project to meet the agreed upon schedule and budget constraints.
  • Identify and manage external R&D resources as needed to complete the project
  • Provide written and verbal project updates with manager, project sponsors and other stakeholders regarding project status, risks/issues and accomplishments
  • Identify opportunities to improve the product development process and proactively lead change as directed by manager

 

Qualifications & Experience:

  • BS in Chemical Engineering or related filed
  • 5+ years of engineering experience with preference to experience in medical device or other regulated industry
  • Must Have: Minimum Qualifications
  • Strong working knowledge of chemical sorbent and ion exchange materials
  • Ability to lead a team to identify and resolve design related requirements and issues.
  • Demonstrated experience in project planning and management
  • Proficiency in Microsoft Word, Excel, Project, PowerPoint, Visio and Minitab
  • Self-starter with strong work ethic and initiative in accomplishing objectives
  • Strong organization and time management skills; ability to manage multiple priorities
  • Attention to detail, thoroughness
  • Strong written and verbal communication including ability to clearly articulate design concepts
  • Able to work in cross-functional and cross-cultural teams

 

Nice to Have:

  • PhD in Chemical Engineering
  • Dialysis experience

  • Demonstrated experience in the design and development of water filtration systems from concept through commercial readiness
  • Proven ability to work well in team environment, with sound negotiation and problem solving skills
  • Ability to lead, energize and influence change efforts at all levels of a complex organization
  • Demonstrated ability to get results through others not under direct supervision
  • Able to work under deadlines and handle multiple detail-oriented tasks simultaneously
  • Able to work independently and across different geographies.
  • Superior interpersonal, verbal and written communication skills; able to communicate effectively and interact with personnel at all levels of technical ability and expertise


Posted: April 3, 2019, 6:50 am
Category : Mechanical Engineer
Job Type : Permanent
Id : 7621
Region : Twin Cities

Seeking a Senior Mechanical Design Engineer to design and develop medical device and drug delivery products, following the Design Development Process (DDP) and applicable standards such as ISO 13485 with design controls, ISO 14971 and appropriate ASME standards.

Essential Functions:

  • Operate primary CAD systems such as SolidWorks or Creo
  • Generate product designs that meet product requirements
  • Identify and analyze design risks using tools such as tolerance analysis, static or dynamic simulation or hand calculations.
  • Develop appropriate design risk mitigations and test strategies
  • Work with production facilities to understand and incorporate production intent design for manufacturing (component level) and design for assembly (assembly level) into the design.
  • Develop appropriate assembly and test fixtures to aide in the manufacture and testing of the design,
  • Integrate the electronic elements into the product design
  • Develop appropriate drawings to detail product and assembly specifications in a manner compliant with ASME or other design standards
  • Maintain a design journal that identifies product risk and tracks design changes throughout the Design Development Process.
  • Generate Database Approval Forms and Engineering Change Orders to document design changes and customer approval.
  • Identify and assess Design Risk via a dFMEA
  • Identify potential manufacturing risks within the design of the components and assembly.
  • Use or coordinate appropriate analytical techniques such as Tolerance Analysis, MoldFlow, SWX Simulation, SWX Plastics or ANSYS to aide in the analysis of the design
  • Ensure that design inputs and outputs are properly documented and controlled according to relevant procedures.
  • Generate and control Drawings and Specifications according to relevant work instructions
  • Other duties as assigned

Required Qualifications:

  • Bachelor of Science in Mechanical Design or Engineering
  • Minimum 7 years of experience in the design of mechanical or electro-mechanical drug / biologic delivery devices (pen injectors, auto-injectors and wearable pumps).
  • Plastic injection molding and product development
  • Design experience with medical devices or similar products
  • Strong Design for Manufacturability experience focusing on plastic injection molding and plastic assembly methods (snaps, sonic welding, press fit, sealing, etc)
  • Proven history of providing innovative design solutions
  • Experience performing tolerance analysis and structural analysis
  • Diverse product portfolio

Skills and Abilities:

  • Familiar with ISO 13485 and ISO 14971
  • Ability to generate complex surface models
  • Familiar with various plastic materials and design limitations or potential design risks for said material
  • Strong written and verbal communication skills; ability to communicate design intent to a diverse audience
  • Experienced understanding of injection mold operation
  • Understanding of the behavior of plastics and other materials as they relate to mechanics, function and creep
  • Demonstrates strong ability to evaluate and recommend appropriate prototyping processes (i.e. SLA, printed, machined, molded)
  • Maintains and respects customer, project, and program confidentiality
  • Motivated self-starter who is able to manage multiple tasks


Posted: April 2, 2019, 1:36 pm
Category : Project Manager
Job Type : Permanent
Id : 7617
Region : Twin Cities

Seeking a Project Manager to be the primary customer interface during all project phases of design, supply, production, factory testing, delivery, install, and customer site acceptance testing. This individual will be responsible for project leadership on build to print and custom automation design and build projects.

Responsibilities:

  • Provide leadership to drive project related decisions (technical & non-technical)
  • Develop detailed project plans and specification documents
  • Identify resources by discipline required for successful project milestone deliveries.
  • Work with organization management on early identification and labor durations of project resources
  • Plan and lead all internal and customer project design reviews throughout project execution
  • Execute project plans which are designed to exceed financial targets
  • Manage quality, schedule, cost, and customer satisfaction
  • Manage contract compliance as it relates to "as sold" scope, allowable deviations, scope changes requiring purchase order adders, timely release of invoicing, and payment receivables

Requirements:

  • Ideal candidate will have the ability to manage multiple projects of varying degrees of complexity simultaneously, proven leadership, planning and organizational skills, and strong technical background in automation design.
  • Candidate must demonstrate proven "systems" approach to project management and the drive to consistently deliver on commitments.
  • Qualified candidate will have a BS or MS in Engineering or Technical discipline and 8-10 years of relevant experience. Significant team leadership experience, preferably in a project environment, is desired.


Posted: March 27, 2019, 10:51 am
Category : Firmware Engineer
Job Type : Contract-to-Hire
Id : 7608
Region : Twin Cities

Seeking a strong Firmware Engineer that demonstrates an extensive knowledge and understanding of firmware engineering principles, concepts, practices and theories. Responsibilities may include research, design, development and test of complex embedded software. Work closely with other engineering and functional areas to obtain optimum utilization of equipment, machinery and resources.

Primary or Major Responsibilities:

  • Coordinate and interface with other design personnel to design, execute and test prototype firmware builds.
  • Interface with quality and manufacturing engineers in ensure proper product quality and manufacturing transfer.
  • Participate in product failure analysis activities and compile test and failure analysis reports.
  • Generates design documentation and report data from tests.
  • Keep accurate and complete records of engineering activities.
  • May act as project lead including organizing, execution, and coordinating technical assignments.
  • Evaluate materials and systems, identify equipment, or prepare work instructions for manufacturing.
  • Provide training and/or direction to other engineers, technicians or manufacturing operators.
  • Provide input to bid and proposal activities.
  • Provide communications and/or presentations to customers, suppliers or vendors.
  • Travel and participation in product field tests.

Minimum Requirements:

  • BS Engineering, Software Engineering, Computer Engineering, Computer Science, or related discipline.
  • A minimum of five years related experience.
  • US Citizenship Required.
  • Experience / training in software design analysis and coding for embedded systems.
  • Experience developing embedded software in C and C++ is required.
  • Desktop and network software development experience a plus.
  • Proficient user of software tools (compiler, assemblers, debuggers, programmers, JTAG, etc.).
  • DSP, digital filtering, microcontroller, and SOC knowledge and experience desirable.
  • Experience with A/D and D/A converters, and serial communications preferred.
  • Knowledge of data acquisition concepts, instrument control, test, measurement, and implementation of control interfaces to hardware.
  • Practical skills for bench level work, including the ability to configure test equipment to verify design.
  • Able to draw solutions from both formal training and experience.
  • Able to use original thinking and ingenuity to solve problems.
  • Experience in generating design documentation, ability to write technical reports and proposals, provide cost and schedule estimates, and participate in presentations.
  • Proficient in MS Office applications (Word, Excel, PowerPoint)
  • Must show high initiative, motivation, and the ability to act independently to resolve technical issues.



Posted: March 7, 2019, 9:23 am
Category : Mechanical Engineer
Job Type : Contract
Id : 7598
Region : Twin Cities

Seeking a Mechanical Design Engineer to support the development of a novel hemodialysis system that utilizes chemical sorbent technology. This position works in collaboration with a global team tasked with development and verification of the chemical sorbent component of the system with a strong emphasis on test development.  This position works independently with limited supervision and direction.  Must be self motivated. Estimate 50% lab work.

 

Position Responsibilities:

  • Use engineering principles to assist in the design and testing of a chemical sorbent cartridge used with a novel hemodialysis system
  • Plan and conduct experiments to characterize the sorbent cartridge and associated components.
  • 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
  • Develop complex test systems to support new product development and design changes.
  • Write Plans, Protocols, and Reports to support Test Method Characterization and Validation and Design Verification
  • Design and implement experiments to support proof of concept and verification activities.
  • Develop and qualify test systems software and hardware.
  • Develop data acquisition systems and perform mathematical and statistical analysis of captured data.
  • Document all development activities to ensure design traceability.
  • Perform troubleshooting and root cause analysis of complex electro-mechanical systems.
  • Identify issues and develop recommendations/suggestions for solutions to communicate to design engineers.
  • 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 required, Mechanical Engineering preferred
  • 2-5 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 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:

  • MS or PhD in Mechanical or Biomedical Engineering or related field
  • 7+ years of experience in medical device R&D
  • Working knowledge of packed bed chemical reactor design and characterization
  • Working knowledge of the principles of hemodialysis
  • CAD experince (Creo) is helpful but not required


Posted: February 22, 2019, 9:07 am
Category : Firmware Engineer
Job Type : Permanent
Id : 7579
Region : Twin Cities

Seeking a Senior or Principal level Engineer to develop embedded software for new products and maintain existing product lines through improvement updates. Preference is someone experienced working with open source tools as well as traditional embedded software technologies used in a regulated environment for medical devices.

The person in this role will join a team of both seasoned and junior engineers that have taken on newer development technologies, bring expertise in embedded software to confidently take over ownership of existing code bases, and partner with leaders to realize our future technology roadmap. They will also drive identification of the best technologies for leading edge product development and methodologies that support high-performing teams.

 

Duties and Responsibilities

  • Take ownership of development of existing C/C++/C++ v11 software development and lead direction and architecture for new development of infusion pumps and other medical devices
  • Adapt and extend existing embedded Linux platform to add new features to current products, analyze the existing architecture and if applicable, adjust and extend it to allow reuse across additional future products
  • Drive future product platform (Linux, RTOS, Bare Metal, homegrown etc.) and architecture decisions based on product use cases and requirements as well as critical review of projects and product roadmap
  • Provide technical expertise and mentoring to other Engineers towards building effective teams
  • Plan, estimate, and schedule software project efforts; monitors and evaluates progress to plans, adjusting as needed to deliver results to plan
  • Lead, review, and guide technical work and issue resolution providing multiple options and ensuring that all work meets requirements and specifications in compliance with the quality system and best practices
  • Maintain frequent communication within and outside of the department in support of engineering activities and project plans
  • Assure appropriate documentation for assigned projects
  • This position is required to assure compliance of Company operations to all applicable laws, regulations and standards, good business practices and company documented procedures (including knowledge of all standards, government occupational health and environmental regulations and statutes related to the site)
  • Engage others, promote, and participate in Environmental, Health, and Safety initiatives, focusing on continuous improvement.

 

Required Skills and Experience

  • 4 year degree in engineering or similar 9-13 years of experience or 5-9 years with an advanced degree.
  • 5 year of Embedded Linux experience (Buildroot, Yocto, or similar)
  • Experience writing C and C++ applications running on Linux, RTOS, bare metal, uCOS, or similar
  • Experience python and bash scripting and creating automated test frameworks
  • Experience working with UI frameworks such as Qt, Altia, WPF or similar
  • Applies extensive technical expertise in the engineering field and has knowledge of other related disciplines (Global Product Management, Quality, Regulatory, Sales and Operations)
  • Experience in regulated product development environments preferred
  • Act as a "Full Stack" developer for all areas of an embedded device (UI, communications, databases, drivers, OS) through all stages of the development process, including for example, requirements, architecture design, coding, test, documentation, and safety analysis
  • Write clean, safe, readable code
  • Develop and debug complex software systems
  • Lead a group of developers
  • Break larger projects into smaller, more executable pieces
  • Independently plan, schedule, conduct and coordinate all phases of the software projects, operating with wide latitude in collaboration with leadership
  • Work in an Agile development environment using tools such as Git, Jira, TFS, etc.
  • Lead, establish, and maintain effective working relationships
  • Coach and mentor others in technical matters and related project initiatives
  • Work under only general supervision from the Engineering Manager, with direction given only in terms of broadly stated objectives and desired outcomes
  • Ability to clearly convey ideas and concepts verbally and in writing
  • Strong influencing skills and ability to convey clear supporting evidence for proposals
  • Ability and willingness to lead and create change – changes in policy, procedure, technology, and culture

 

Posted: January 24, 2019, 12:26 pm
Category : Packaging Engineer
Job Type : Contract
Id : 7578
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: January 22, 2019, 9:36 am
Category : Electrical Engineering
Job Type : Permanent
Id : 7577
Region : Twin Cities

This is an excellent opportunity for a Lead Senior Electrical Engineer. The successful candidate will engage as a member of a highly technical and energized development team, performing and leading electrical engineering design and development. This key individual will also serve as part of the leadership team.

Essential Job Functions:

  • Provide technical leadership to electrical engineering team members, including instructing and verifying team members' work.
  • Lead in creating Electrical Engineering proposals to capture new business
  • Server as overall Electrical Engineering System' Engineer and Architect
  • Own and drive overall technical and process excellence in the EE function
  • Develop specifications for electronic products, assemblies, and parts.
  • Design, integrate, and document a variety of electrical concepts, prototypes, and products.
  • Meet with new and current Customers to understand design specifications, schedules and budgets.
  • Conduct design analysis to ensure manufacturability, reliability and client electrical requirements are met.
  • Prepare technical documentation, including architecture, detailed design and verification test documents as required.
  • Plan and perform tests to ensure that products achieve performance and reliability goals.
  • Insure regulatory and safety compliance providing all the required information and documentation as required.
  • Select components and suppliers and manage an inventory of components and information for each separate project.
  • Train other employees as well as external personnel as requested.

Position Qualifications:

  • BS degree w/5-10 years of experience or MS degree w/3-7 years of experience
  • Experience in the complete product development process, including design and project definition, development, testing, and on-time execution.
  • Hardware Engineering experience (design, schematic, layout, integration, BOM, ECR / ECO, test, and qualification).
  • Experience with creating, troubleshooting, and editing embedded firmware.
  • Strong analytical skills.
  • Accountability – takes responsibility for decision, actions and results.
  • Open and candid communication skills, demonstrate inclusive behavior, and demonstrate the ability to build trust and inspire others.
  • Initiate and guide troubleshooting agenda for sudden "critical" problem areas.
  • Responsible for medium to large projects or multiple tasks within the engineering functional discipline.
  • Makes significant contribution to their team by applying hardware engineering knowledge.
  • Works independently on projects.
  • A solid understanding of the fundamentals of Electrical Engineering and will work to continue developing specialized knowledge.
  • Formal classes or 3 years of experience designing at least two different types of circuits: digital, analog, RF, wireless, optical, power supplies, low voltage, high voltage, or others.
  • Formal classes or 3 years of experience designing for at least two different markets: medical device, consumer, audio, communications (voice, video or data), industrial controls, robotics, military, PC, PC peripherals, or others.
  • Excellent written and verbal communication skills.
  • Able to read and write simple scripts or software programs
  • Familiar and comfortable with designing PC boards, performing layout, and reviewing boards after fabrication.
  • Ability to effectively work multiple projects simultaneously.
  • Wireless development including IoT.
  • This position has minimal travel requirements (up to 10%).
  • Ability to work cross-functionally with other engineering disciplines (e.g., Mechanical, Firmware, Software).



Posted: January 18, 2019, 9:33 am
Category : Manufacturing Engineer
Job Type : Permanent
Id : 7563
Region : Twin Cities

Seeking a Manufacturing Continuation Engineer to provide support for existing product lines. This includes resolving issues such as obsolete components, cost reduction efforts, ease of assembly, addition of options, improved product functionality, and continuous improvement of product quality and performance.

 

Responsibilities:

  • First engineering responder on existing product line issues and production assistance
  • Seek out opportunities for cost reduction on existing products by reducing cost of materials/parts and process improvement.
  • Research and identify issues with existing products which involves talking with other departments, testing, prototyping, reviewing warranty claims, inventories and other activities.
  • Works with other departments to expedite production changes.
  • Aid in identifying support/production requirements of new products.
  • Manufacturing assistance on process improvements
  • New design on accessories and attachments.

 

Requirements:

  • Associates or Technical Diploma in Manufacturing or Industrial Engineering required.
  • 2+ years' experience in cost reduction, process improvement, and reliability experience for existing product lines.
  • Experience in manual machining nice but not required.


Posted: December 11, 2018, 8:55 am
Category : Controls Engineer
Job Type : Permanent
Id : 7556
Region : Twin Cities

Seeking a Systems Engineer to develop control system design and application of various technologies including: multi-axis motion control, image processing, vision-guided robotics, industrial instrumentation & automatic control. This position will provide technical leadership in a team-oriented work environment, interface with customers on technical projects, system programming PLC/motion/vision, startup/commissioning of machine control systems.

Requirements

  • BS or MS in Mechanical or Electrical Engineering with control system emphasis (min 3.2 GPA) and relevant intern or co-op experience.
  • Strong electromechanical aptitude.
  • Motion control/Robotics experience (Delta Tau, Adept, Yamaha, Epson).
  • PLC/PC programming experience (Allen-Bradley, GE Fanuc, etc.).
  • Vision experience (Cognex, DVT, Adept).
  • Solid organizational skills.
  • Strong desire to work in a fast-paced, entrepreneurial environment.
  • Ability to consistently deliver on commitments.


Posted: December 6, 2018, 9:22 am
Category : Electrical Engineer
Job Type : Permanent
Id : 7557
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: December 6, 2018, 9:21 am
Category : Software Engineer
Job Type : Contract
Id : 7548
Region : Twin Cities

 

Essential Job Functions & Responsibilities:

  • Embedded firmware design and implementation
  • Support projects for new and existing customers. This will require theoretical analysis, simulation analysis, software/firmware implementation, code review, documentation, and hardware/software integration testing.
  • Support communication protocol development efforts: network security protocols, wireless mesh networking and network security
  • Support development in multiple operating systems:  Linux, FreeRTOS, bare metal, Windows, etc.
  • Coordinate and work collaboratively cross functionally as well as with other software development teams in the organization
  • Lead software efforts being self-directed as well as leading small software teams
  • Mentor junior engineers in current trends and best practices
  • Provide outstanding documentation of software designs
  • Assist with certification testing
  • Coordinate software releases with internal and external stakeholders
  • Participate in appropriate training and development programs to maintain and enhance job-related skills

 

Required Qualifications:

  • Minimum: BS or MS in Computer Engineering, Electrical Engineering or Computer Science
  • 10+ years of related experience
  • Direct experience in programming in C for real-time embedded systems
  • Significant experience working with 32-bit microcontrollers in a flash and RAM constrained system
  • Significant experience with microcontroller peripherals and interfaces: UART, SPI, ADC, PWM, Timers, etc.
  • Development experience with embedded Linux (layers below application) and RTOS/bare metal
  • Skilled in the use of test and debug equipment: oscilloscopes, logic analyzers, multi-meters, spectrum analyzers, etc.
  • Demonstrated ability to function self-directed in leading software engineering efforts
  • Demonstrated ability to lead a small team of software engineers, i.e. task planning/managing, mentoring, defining core architecture, etc.
  • Good communication and team skills, both externally and internally
  • Solid debugging, troubleshooting, and problem solving ability
  • Eagerness to collaborate with team members and coworkers within the organization
  • Solid experience in delivering quality documentation (Requirements, Design Doc's, test plans)
  • Experience working through all phases of software development (Concept, architecture, development, test, release to manufacturing)

 

Preferred Qualifications:

  • Experience in developing Linux Kernel drivers, and low level Linux protocols
  • Experience in developing in real-time operating systems
  • Experience with RF communication
  • Experience with RF protocols at the PHY/MAC/NWK layers such as 802.15.4, zigbee, BLE, or Wi-Fi
  • Experience with networking protocols
  • Experience with a revision control system, GIT is preferred
  • Python experience
  • Experience with unit testing


Posted: November 20, 2018, 11:57 am
Category : Electrical Engineer
Job Type : Contract
Id : 7541
Region : Twin Cities


 

Electrical Engineers work cross functionally to bring products from concept through development and into production. Electrical Engineers are responsible for the electrical design, schematics, safety and test, along with the failure analysis and continuation of Class II/III medical devices.

 

Responsibilities:

  • Design and develop embedded microprocessor systems.
  • Devise, test, and debug system-level architecture for new products of moderate and significant technical complexity.
  • Design and develop sensor interfaces including A/D conversion, filtering, etc.
  • Create and enter PCB schematics and assist with PCB layout.
  • Design and develop analog and digital circuitry.
  • Develop and perform hardware verification testing.
  • Participation in product requirements definition, analysis, project planning, and design reviews.
  • Write design specifications.
  • Assist with agency compliance testing in accordance with EMC and IEC 60601-1 standards.
  •  

Qualifications:

  • BS degree in Electrical Engineering or Computer Engineering.
  • 5+ years of experience with embedded products.
  • Experience with digital and analog electronic device development.
  • Experience taking a device from design to production
  • Detailed documentation skills. Medical Device experience preferred but not required.

 

Posted: November 5, 2018, 1:26 pm
Category : Firmware Engineer
Job Type : Contract
Id : 7526
Region : Twin Cities

Excellent opportunity for Embedded Software Engineer to work as part of a medical product development team, assisting with firmware development on a variety of medical devices involving a variety of technologies. Some projects involve concept prototyping, but most are development of end products.

Responsibilities:

  • Develop medical device firmware and user interface software.
  • Specify, design, code, integrate and test medical device software.
  • Define and execute tasks and development approach necessary to meet requirements and schedule.
  • Comply with Standard Operating Procedures for product development and software engineering.
  • Take task direction from Software Engineers and the assigned Program Manager.

Qualifications:

  • 10+ years embedded software development expertise in a regulated industry such as medical, automotive or aerospace, using the C or C++ languages.
  • BSCS, MSCS, BSEE, MSEE or similar degree or experience, but if EE must have very significant software engineering capabilities.
  • Must be able to work proactively and thoughtfully with minimal supervision.
  • Must be familiar with at least one configuration management tool (eg. Subversion, MKS, etc).
  • FreeRTOS, OpenRTOS, SafeRTOS.
  • Real-time control algorithms, including PID, stepper motors, heaters, pumps, etc.
  • Automated unit test, for example VectorCast or similar.
  • Excellent communication skills, including ability to write documentation using MS Office (MSWord).
  • Comfortable working with a defined coding standard.
  • Proven ability to perform well with a variety of target controllers, development tools, and sophisticated control algorithms.
  • Proven ability to learn quickly


Posted: October 22, 2018, 8:22 am
Category : Electrical Engineer
Job Type : Contract-to-Hire
Id : 7527
Region : Twin Cities

Seeking a Sr. Electrical Engineer that provides knowledge and understanding of electrical engineering principles and concepts. Responsibilities may include research, design, development and test of electrical engineering designs and concepts. Work closely with engineering and other functional areas to obtain optimum utilization of resources. Looking for a very dynamic electrical engineer who enjoys designing and debugging complex embedded systems. Must be highly self-motivated and an excellent communicator.

Primary or Major Responsibilities:

  • Design, model, simulate and test electronic circuits under guidance of other engineers.
  • Support designs with simulations, and cross-disciplinary engineering reviews.
  • Create schematic drawings and support PCB design and layout.
  • Prepare documentation and drawings for work as required for engineering and manufacturing of products
  • Conduct and guide external and in-house and pre-scans and regulatory testing with guidance from other Engineers.
  • Support risk, failure and root cause analysis as required within the electronic engineering discipline.
  • Provide training and/or direction to technicians.
  • Provide input to bid and proposal activities.
  • Provide communications and/or presentations to customers, suppliers or vendors.
  • Require participation in product field tests requiring travel.

Minimum Requirements:

  • BSEE; 5-7 years experience, 7+ years preferred.
  • Must show high initiative, be self-motivated, and have ability to act independently on technical matters
  • Ability to draw solutions formal training and experience and use original thinking and ingenuity to solve problems.
  • Experience in Altium, Cadence, or Mentor graphics is required.
  • Knowledge/skills must include education in electronic design, simulation, modeling, analysis, and test of electronic assemblies and systems is required.
  • Knowledge of digital and analog design in embedded design is required. This may include amplifiers, analog and digital interfaces, low power design, communication interfaces and protocols, microcontrollers, and solid state memory devices.
  • Windows and some Linux experience, as well as experience with general PC-based tools such as MS Office applications (Word, Excel, and PowerPoint).


Posted: October 17, 2018, 7:33 am
Category : Mechanical Designer
Job Type : Contract
Id : 7521
Region : Twin Cities

The Mechanical Designer will be responsible for design of special machines, fixtures, and automated production equipment. Prefer a 2 year degree in mechanical design and 4 to 8+ years of hands on automated equipment design experience, from concept through detailed design. Requirements include strong SolidWorks design skills, and experience in one or more of the following areas: product packaging or assembly equipment, dial and indexing systems, robotics, motion control, for manufacturing equipment. Ability to specify components, drives, material handling systems, pneumatics, and related automation components is required, and experience with medical / pharmaceutical equipment design preferred.



Posted: October 11, 2018, 12:01 pm
Category : Sales
Job Type : Permanent
Id : 7488
Region : Twin Cities

Development Resource Group is a fast-paced, well-established engineering staffing firm seeking a motivated and energetic individual to join our growing recruiting team. Development Resource Group has been supplying contract and direct hire technical staffing since 1986 specializing in Medical Device, Engineering, R&D, and Product Development.

DRG specializes in placement of hardware, software, and mechanical engineering personnel on projects with many high tech product development companies in the Twin Cities. Our engineers are responsible for design, programming, and testing of products for medical device, electronic products, and automation systems.

The Technical Recruiter must have excellent communication skills, a high level of computer system knowledge, and preferably direct experience in sourcing, interviewing, and placement of high-level product development engineers.

We are seeking an individual to manage the full recruiting lifecycle: sourcing, screening, interviewing, reference checking, and negotiating employment terms. The candidate will be well versed in all aspects of professional recruiting, including networking and the recent trends in hiring.

Ideal candidates will be skilled in the use of applicant tracking systems and be self-sufficient in navigating and administering the applicant flow process.

Prefer BS degree, with proven track record of success in the staffing industry.

We offer excellent earning potential, a competitive benefit package, and an opportunity to be successful in the fast-paced, growing technical staffing industry.


 

Posted: September 6, 2018, 9:34 am
Category : Sales
Job Type : Permanent
Id : 7487
Region : Twin Cities

Development Resource Group is a growing Technical Staffing firm located in Mounds View, MN. Since 1986, DRG has been assisting clients in locating experienced engineers for project-based work on a temporary, contract-to-hire, or permanent basis. We specialize in placement of hardware, software, and mechanical engineering personnel with a strong base of high tech product development companies in the Twin Cities. Our engineers are responsible for design, programming, and testing for medical device products, electronic products, control products and automation systems.

We are seeking a motivated and energetic individual to add to our Sales Team as an Account Representative. Account Representatives are responsible for working with our clients in establishing their needs and then working with our recruiting staff to fill those needs. Additionally, they support all contracted staff though the duration of their project, working to ensure both client and contractor's satisfaction. Candidates must have excellent communication skills, a high level of computer systems knowledge, technical staffing experience, be self-motivated and enjoy working in the "people business." A college degree is preferred, with several years of staffing sales experience and/or recruiting experience in a Technical or Engineering field.

We offer an enjoyable working environment with a proven track record in our industry, excellent earning potential, a very competitive benefits package and an opportunity to be successful in the fast-paced, growing technical staffing profession.



Posted: September 6, 2018, 8:20 am
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 : 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 : 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