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Development Resource Group

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Category : Quality Engineer - Medical Device
Job Type : Contract
Id : 7544
Region : Twin Cities

The Sr. Design Assurance Engineer provides technical engineering support to sustaining engineering teams in the medical device industry. This individual will be expected to apply his/her knowledge of design control principles, risk management file documents, applicable industry standards, and regulatory requirements to sustaining efforts, as a member of one or more cross-functional development team(s). This includes quality planning, establishment, execution, and optimization of quality system processes for the site quality function. This position also consults with other functions and Business Units in the development and maintenance of their quality systems, assists with compliance data collection, analysis and reporting for a variety of internal and external reports, and serves as a compliance consultant for the organization.

Major Responsibilities:

  • Monitor external regulatory environment to identify and understand trends in enforcement of US and International QS Regulations.
  • Initiate compliance initiatives to support and influence increased global compliance maturity and efficiency.
  • Supports sustaining engineering efforts on commercialized products
  • Executes quality engineering deliverables required by the Product Development Process as needed.
  • Identifies and manages risk throughout the development process and sustaining efforts with the use of FMECA and/or other risk management tools.
  • Participates in developing master test plans that encompass design verification, design validation and process validation activities.
  • Evaluates test protocols and reports to ensure that the testing is sufficient to meet regulatory requirements and quality objectives.
  • Provides input to design and manufacturing documentation including material specifications, drawings, inspection procedures, and manufacturing procedures, to ensure that the resulting products can be adequately manufactured and tested.
  • Participates in supplier selection process and specification reviews with suppliers to ensure that purchased items meet Company specifications.

Required Qualifications:

  • BS in engineering or science. MS desirable.
  • 5 plus years of experience in Quality Engineering in medical device industry
  • Experience in related areas, e.g. R&D or Manufacturing may also be applicable if experience includes work responsibilities listed above
  • 1 - 3 years of experience in Quality Assurance, including Quality systems, standards, metrics, and tools desirable
  • Familiarity with EU Medical Device Directive (EU MDD 93/42 EEC), EU Medical Device Regulation, ISO 13485:2003, ISO 14971


Posted: November 12, 2018, 11:14 am
Category : Electrical Engineer
Job Type : Contract
Id : 7543
Region : Twin Cities

The Electrical Engineer will develop electrical circuits, test methods, and related documentation for control consoles as a team member of the Research and Development group. The Electrical Engineer will assist in all development projects ranging from concept and technology development through commercialization and post-market support.

POSITION RESPONSIBILITIES:

  • Design, develop, and modify electrical systems and devices, including prototypes, production tools, and test fixtures in a highly regulated environment
  • Research product development solutions and provide analysis for product direction
  • Create related documentation and support materials in conjunction with design and development activities
  • Consult and solicit feedback from internal stakeholders to identify customer needs and translate these requirements into the electrical designs. In addition, provide support regarding product development to internal departments as it relates to electrical design.
  • Ensure that all interactions and engagements are carried out with the highest ethical and professional standards and that all work is accomplished with quality and in accordance with Company values

POSITION REQUIREMENTS:

  • Bachelor’s degree in electrical engineering; Master’s level desirable
  • 5+ years of experience developing electrical systems including analog and digital circuitry
  • Experience with developing embedded circuits including designs with FPGAs is desirable
  • Experienced with developing and verifying products to IEC 60601-1 medical electrical equipment safety and EMC regulations
  • Hands-on experience with troubleshooting designs, building prototype devices, and performing experiments
  • Experienced with specifying and developing production tests for electrical designs, writing protocols, analyzing results, and writing reports
  • Competence with schematic entry and PCB layout tools is required
  • Experience with regulated medical devices and quality systems
  • Capable of evaluating circuit designs using electronic test equipment including oscilloscope, signal generator, spectrum analyzer, and impedance analyzer
  • Experienced with analog and digital simulation software tools
  • Capable of reading and understanding electrical component specifications
  • Highly self-motivated and directed
  • Keen attention to detail
  • Ability to create clearly-worded documents describing design ideas, test details, and project status
  • Ability to adapt and learn new technologies
  • Proven analytical and problem-solving abilities
  • Ability to exercise independent judgment and discretion by effectively prioritizing, planning, tracking and executing team activities in a high-pressure environment
  • Strong customer service orientation
  • Experience working in a team-distributed, collaborative environment
  • Ability to manage and prioritize work load, multi-task and manage a diverse mix of issues, responsibilities and challenges
  • Exceptional ethical standards including the ability to be very discrete in the handling of confidential and privileged information
  • Self-starter with a hands on, pragmatic approach and a “can do” attitude



Posted: November 9, 2018, 1:32 pm
Category : Systems Engineer
Job Type : Contract
Id : 7542
Region : Twin Cities

Seeking a Systems Engineer with a strong background and is passionate about system maturity/reliability, integration, characterization, verification, and validation. The ideal candidate would be someone with relevant educational and/or demonstrated experience maturing complex systems with significant electrical and/or software components.

Position Responsibilities:

  • Work with peer systems engineer(s) during development of user needs & intended uses and design input requirements to ensure they are validate-able and verifiable respectively
  • Authors a system level Verification & Validation Plan, documenting scope of system V&V effort, while working with product/functional engineers to ensure proper and complete coverage
  • Authors Integration Plan and corresponding test protocols during design development phase of project to progressively and predictably build design maturity. Executes tests per defined Integration Plan
  • Works with various stakeholders to understand scope of characterization needed, including need to understand design capability. Executes system characterization efforts
  • Influence product/component integration and characterization plans in order to assist in incremental system maturity. Works with engineers in various functional departments to achieve results
  • Authors design verification and design validation protocols and reports. Executes system verification and validation activities
  • Works with Human Factors engineer to ensure inclusion, tracing and proper coverage of applicable user needs in their summative usability study
  • Works with Clinical to ensure inclusion, tracing and proper coverage of applicable intended uses in their pre-clinical or clinical study
  • Plan and execute Test Method and Non-product software validation, and equipment and tooling qualification, per project needs
  • Monitors progress of assigned tasks to defined project schedule
  • Produce high quality deliverables while complying with relevant SOP
  • Authors Summary report and other relevant inputs for submission by Regulatory Affairs to regulatory agencies in support of market release review and approval

Requirements:

  • 4+ years of job-related experience with a Bachelor’s degree; or 2+ years of job-related experience with a Master’s degree

Preferred Qualifications:

  • Bachelors or Master's Degree in Biomedical Engineering, Systems Engineering, Electrical Engineering, Computer Science, Reliability Engineering, or Mathematics
  • Experience in engineering and testing mission critical systems and/or medical device systems
  • Demonstrated experience maturing System with significant electrical component
  • Experience working with detailed requirements and traceability in order to author test plans, protocols, and reports
  • Experience working in cross-functional team effort
  • Demonstrated strong verbal/written communication and influence management skills
  • Proven ability to accomplish critical project level objectives in a team environment
  • Knowledge of or experience working with Systems Engineering principles
  • Knowledge of or experience working in a regulated and/or FDA medical device environment Knowledge of or experience working with ISO and Quality System Regulation requirements


Posted: November 7, 2018, 8:15 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 : Electrical Engineer
Job Type : Contract
Id : 7539
Region : Twin Cities

Seeking a Principal Electrical Engineer to be responsible for providing sustaining engineering design and technical support for non-implantable medical devices in the field. This candidate will apply their technical expertise towards design solutions of complex technical problems and provide solutions that may require the use of ingenuity and creativity.

POSITION RESPONSIBILITIES:

  • Provide electrical engineering skills to troubleshoot, develop, and debug analog and digital circuitry for released product initiatives.
  • Design and execute test methods to characterize circuit performance and verify adherence to requirements including test automation.
  • Analyze returns and complaints from the field to determine root cause and propose solutions.
  • Test devices in a global regulated environment including EMI/EMC, EN60601-1, and FDA requirements.
  • Effective member of a cross-functional team including firmware and mechanical functions.
  • Ensure personal understanding of all quality policy/system items that are personally applicable. Follow all work/quality procedures to ensure quality system compliance and high-quality work.
  • Analyzes, updates, and maintains Medical Device systems and features that meet the expectations and uses of the customer, regulatory agencies, and the business.
  • Provides technical leadership in the evaluation and maintenance of released product designs across functional groups.
  • Documents tradeoffs, rationale, and potential solutions.
  • Provides field support to customers and clients for Medical Device systems.
  • Contribute and build domain knowledge around implantable medical device based systems, their clinical use and application via customer and field visits, literature searches and training.
  • Ensure personal understanding of all quality policy/system items that are personally applicable. Follow all work/quality procedures to ensure quality system compliance and high-quality work.

BASIC QUALIFICATIONS:

  • B.S. Degree in Electrical or Computer Engineering
  • 5+ years of experience in an electrical engineering role; or
  • 3+ years of job-related experience with Applicable Master’s Degree

DESIRED/PREFERRED QUALIFICATIONS:

  • Experience with design and debug of consumer electronics products
  • Experience debugging issues from fielded products to determine root cause
  • Experience with discrete component replacement
  • Knowledge of ISO and Quality System Regulation requirements.
  • Proven leadership experience via facilitation of a cross-functional team effort. Strong verbal/written communication and influence management skills.



Posted: November 2, 2018, 1:31 pm
Category : Controls Engineer
Job Type : Permanent
Id : 7538
Region : Twin Cities

We have an excellent opportunity for a Controls Engineer to engage as a member of a highly technical and energized development team creating, editing, and designing control systems for a wide range of mechanical and machine design and build activities in a professional, cost effective and expeditious manner. Emphasis will be on a systems engineering approach. Primary direction will be received from a Project Manager, Client or Senior Staff Engineer.

Essential Job Functions:

  • Create PLC algorithms for various machine development programs
  • Documentation of electrical, pneumatic, hydraulic, and cooling systems (i.e.: schematics, ladder diagrams, etc.)
  • Provide thorough testing of machine functionality to verify schematic and labeling completeness and accuracy.
  • Work with mechanical teammates to ensure the control system will meet performance, reliability and functionality requirements
  • Work with other members of the design team and others to continuously improve methods of integrating controls technology, with the goals being enhanced safety, enhanced functionality, and reduced cost
  • Human/machine physical interface design
  • Machine start up, testing and debugging
  • Analyze project requirements and perform technical calculations supporting design including electrical requirements, robotic safety standards, and motor controls.
  • Create and finalize designs to meet project requirements
  • Create accurate Bill of Materials
  • Define equipment and parts from external suppliers
  • Conduct cost and time estimation

Education:

  • Technical Associates degree w/2-10 years of experience
  • BS degree w/1-5 years of experience

Experience/Qualifications:

  • Knowledge of multiple PLC platforms (AB, Omron, Schneider, etc.)
  • AutoCAD electrical or similar experience
  • Standard industrial panel designs & components
  • Wiring methods
  • Power distribution wiring
  • Voltage levels and types and their isolation
  • Machine labeling syntax of electrical wiring, components, hoses, etc. and how to document this information in the schematics
  • Component sizing and wiring
  • Knowledge in process instrumentation (flow, level, pressure)
  • Interfacing and communication with devices; analog, fieldbus, etc.
  • Experience in multiple Solid Modeling CAD packages. SolidWorks, Creo, ProE, Inventor, SDRC-Ideas, etc.
  • Understand and able to apply IEEE, CE, UL, NFPA, etc. electrical requirements and standards to designs
  • Experience with Robotics, Laser Systems, and Vision Systems is preferred
  • Highly self-motivated, can work alone with little or no supervision
  • Ability to adapt to/learn new controls technology and software
  • Good communication and troubleshooting skills.
  • Ability to read and understand product specifications.
  • Ability to document discrepancies with detail and accuracy.
  • Highly organized, detail oriented, able to work effectively both independently and in teams.
  • Proficient with the use of Excel, Word and Microsoft Project
  • Thorough understanding of various manufacturing processes
  • Accountability – takes responsibility for decision, actions and results


Posted: November 2, 2018, 12:52 pm
Category : Mechanical Engineer
Job Type : Contract
Id : 7536
Region : Twin Cities

The Project Engineer is responsible for technical project activities to facilitate execution of projects on time and within budget. Under the guidance of the Program Manager this candidate partners key functional core team members (CTM) in the execution of Product Development Sustaining and Stabilization Project efforts.

A DAY IN THE LIFE:

  • Participate in the development of and maintenance of legacy disposable surgical ablation tools used during the performance of cardiac procedures based on detailed concept description or engineering documents
  • Support performance of remediation activities as directed to ensure legacy products meet current requirements and standards
  • Verify the functionality of product design by developing test methods, mechanical fixture designs, and performing test method validations to ensure product designs meet specifications and applicable performance requirements.
  • Interface with vendors, manufacturing facilities and various internal groups to resolve design and manufacturability issues of new and existing products.
  • Assist in creation and communication of project plans, tasks and deliverables, and manage time to meet project deadlines.
  • May lead troubleshooting and problem-solving efforts related to development projects. Support decisions through thorough engineering analysis and data.
  • Remain current with technology and trends within the business.
  • Perform day-to-day job responsibilities in a U.S. and internationally regulated work environment.

REQUIRED:

  • BS in Mechanical Engineering and 3-4+ years of progressive mechanical design experience in a regulated medical industry
  • Proven communication skills and ability to work within a multi-functional team environment
  • A demonstrated capacity for solving problems through creative designs
  • Knowledge of FDA and ISO 13485:2003 to manage medical device materials, related processes, and GMP (Good Manufacturing Practices)

NICE TO HAVE:

  • MS in Mechanical Engineering or other related engineering discipline
  • 2 years progressive mechanical design experience in a regulated medical industry
  • 2 years working with blood contacting surgical ablation devices
  • An understanding of clinical/technical applications of surgical products and human anatomy


Posted: November 2, 2018, 9:38 am
Category : Quality Engineering
Job Type : Contract
Id : 7537
Region : Twin Cities

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

POSITION RESPONSIBILITIES:

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

BASIC QUALIFICATIONS:

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

PREFERRED QUALIFICATIONS:

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


Posted: November 2, 2018, 8:00 am
Category : Technicians
Job Type : Contract
Id : 7535
Region : Twin Cities

Seeking a Senior Technician for the following duties:

  • 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.
  • Seasoned individual contributor, working under limited supervision, and providing assistance and training to lower level employees.
  • Runs minor projects, including performing tests, interpreting data, developing reports.

Position Requirements:

  • Requires minimum of 4 years of relevant experience
  • 2 year technical degree
  • Medical manufacturing experience
  • Extensive troubleshooting experience



Posted: October 26, 2018, 10:04 am
Category : Project Manager
Job Type : Contract
Id : 7534
Region : Twin Cities

The Senior Project Analyst will join the Project Management Office (PMO) to implement, maintain, and improve a consistent Project Management framework. This team member provides the Project Management expertise to enable crisp execution in a cross-functional core team by partnering with the core team leader and members in project planning, execution, and monitoring, as well as other aspects of project management.
Position Responsibilities:

  • Facilitate development and maintenance of the integrated, detailed schedule in MS Project. Partner with team to execute and monitor the project, abiding by the project management framework and using project management software tools.
  • Identify and monitor project team performance metrics. Analyze and present trends and recommendations to peers, core team and senior management. Contribute to or lead teams through project risk analysis, schedule recovery, etc.
  • Maintain and continuously improve the project management processes, guidelines, tools / templates, best practices, and overall implementation. Train teams on adopted project management methodologies.
  • Seek out and engage regularly with peers, creating an environment of exchange and learning. Openly share successes, challenges, and failures to promote the team’s collective learning and overall improvement. Participate in and drive adoptions of lessons learned and best practices.
  • Ensure understanding of all quality policy / system items that are personally applicable. Follow all procedures to ensure quality system compliance and high-quality work.
  • Contribute to optimizing the Design Control strategy and business deliverables to clarify project requirements
  • Contribute and maintain PDP management standards (templates, processes, best practices) for the Design History File (DHF)
  • Strong partnership with the Core Team lead, Program Manager, or Program Director
  • Responsible for creating and maintaining a project management framework that enables teams and Product Review Committee (PRC) to execute projects successfully
  • Designs and implements effective communication vehicles for CTL, Sponsor, team members. Ensures information provided is timely, factual and accurate
  • Seeks information from all sources to understand the project scope, what needs to be done and how. Works with the Core Team to create a comprehensive project plan, budget and schedule
  • Facilitates project risk management
  • Responsible for timely and accurate coaching of the Core Team’s application of best practices
  • Provides PDP project support for Design Reviews and Phase Reviews: organize & review all documentation in preparation for the reviews and completing audits to maintain compliance
  • Operates as role model by monitoring PDP metrics and performance and striving for continuous improvement

Position Requirements:

  • Bachelors degree in science and a minimum of 5 years relevant experience
  • Proven project management skills (managing timelines, budgets, risk management, etc.)
  • Computer skills in MS Office (Microsoft Project, Visio, etc.)
  • Project Management Professional (PMP) certification preferred
  • Experience in executing business process improvements preferred
  • Knowledge of medical device regulatory environment
  • Strong communication (written and verbal) and mediation skills
  • Strong facilitation, Organizational, and problem-solving skills
  • Ability to influence management, think strategically, and delegate effectively
  • Broad understanding of products
  • Detail oriented and Organized
  • Process oriented
  • Audit and compliance experience preferred but not required

Nice to Have

  • 7+ years’ experience in Medical Device Product Development.
  • 7+ years’ experience working in one or more of the following functional areas: Research and Development, Product Development, Instrument Engineering, Healthcare IT, Clinical Research, Regulatory, Marketing, Operations, and/or Quality.
  • Demonstrated strong business acumen and planning.
  • 5+ years’ experience managing projects.
  • Demonstrated excellent downward, lateral, and upward communication skills (oral/presentation and written).
  • Well versed in design for reliability and manufacturability (or design for six sigma) principles
  • Demonstrated strong interpersonal, quantitative analysis, and problem-solving skills.
  • Demonstrated high degree of initiative and influence management skills.
  • Demonstrated track record of successfully leading projects to completion.



Posted: October 26, 2018, 6:42 am
Category : Technicians
Job Type : Contract
Id : 7532
Region : Twin Cities

Seeking a Design Technician who will Design components or portions of systems and modify existing designs to develop or improve products and facilitate manufacturing and field service operations.

Position Responsibilities:

  • Utilizes computer aided design equipment and/or graphic tools, such as CAD, CAM, CATIA, ProEngineer, SolidWorks or Siemens NX Software.
  • Gathers information, makes studies, computes calculations, and prepares original rough layouts, sketches to present design proposal.
  • Coordinates design criteria with engineering, manufacturing, tooling, material, and planning group such as ease of manufacture, availability of materials, and contractual specifications.

Position Requirements:

  • Entry level position
  • Some job knowledge of systems, procedures, basic laboratory techniques and use of standard test instruments preferred


Posted: October 23, 2018, 2:48 pm
Category : Mechanical Engineer
Job Type : Contract-to-Hire
Id : 7531
Region : Twin Cities

Seeking a Mechanical Engineer to provide mechanical and structural design and analysis services to the mechanical engineering group for wind tunnels, aircraft engine test cells and other aerospace ground test facilities.

Essential functions & Accountabilities:

  • Work as a member of a multi-discipline team in the design, and analysis of mechanical subsystems utilized in wind tunnels, aircraft engine test cells, and other aerospace ground test facilities. The mechanical subsystems include welded steel structures, pressure vessels, piping systems, simple and complex mechanisms, rotating equipment, and process equipment (pneumatic, hydraulic, fuel, and cooling water.) The designs shall comply with customer requirements, recognized industry codes and standards, and company standard practices.
  • Prepare design criteria, calculation packages, specifications, cost estimates, schedules and reports.
  • Provide information to and work with mechanical designers in the preparation of technical drawings and parts lists. Check drawings for conformance to design requirements.
  • Support fabrication and procurement by assisting with subcontractor selection, visiting subcontractors to inspect work in progress, and support factory acceptance tests.
  • Travel to customer sites to participate in site surveys, design reviews, and to support equipment installation and commissioning. Travel is typically less than 15%.
  • Interface and coordinate with other technology groups, project management group, marketing and customers as required.
  • Meet the budget and schedule requirements of assigned projects.

Qualifications/Education:

  • BS or MS in mechanical, aerospace or structural engineering.
  • Experience in at least a few of the following areas (in order of importance):
  • Static & transient heat transfer analysis expertise is strongly desired (conduction, convection & radiation)
  • High temperature (>2000• F / >1365K) ceramic and metallic material structural design and analysis
  • Design for fabrication methods including additive manufacturing, machining, welding & forging
  • Analysis & design of pressure vessels & piping in accordance with ASME codes
  • Analysis & specification of process equipment (valves, piping, instruments, filters etc. for pneumatic, hydraulic, and/or cooling water systems)
  • Mechanical design and analysis with supersonic and hypersonic boundary conditions.
  • 4 to 15 years relevant experience and demonstrated previous experience.
  • Familiarity with finite element analysis is required, experience with ANSYS desirable.
  • Familiarity with 3D modeling is required, experience with Autodesk Inventor and Solidworks desirable.
  • Proficiency with MS Office.
  • Ability to travel locally and internationally.


Posted: October 22, 2018, 2:29 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
Id : 7530
Region : Twin Cities

Seeking a detail-oriented, proactive Certification Project Manager to run numerous certification projects. Project coordination entails being main point of contact for customer, arranging certifications with test labs, maintaining MS Project schedule, and managing project budget and finances.

Position Description:

  • Work with test labs and other certification experts to determine what is needed to be able to certify current Company products for sale in counties outside of North America and Europe
  • Gather certification quotes from test labs and estimate support labor for potential certification projects.
  • Writing statement-of-work documents, which function as project proposals
  • Consult with internal Company employees to find test reports, product information, and any other information or help needed to complete new country certifications for existing Company products
  • 20-40 hours per week
  • Certification/regulatory and engineering experience preferred but not required



Posted: October 22, 2018, 8:14 am
Category : Quality Engineer - Medical Device
Job Type : Contract
Id : 7529
Region : Twin Cities

Seeking an Associate Quality Engineer to provide Quality Assurance (QA) support to the manufacture of components used in implantable grade, medical devices. This position Monitors products, processes, and projects and recommends changes to improve operating efficiency. Provides support in areas of process engineering, product QA and quality engineering to drive continuous process and product improvements. Supports assigned product lines and manufacturing processes to ensure highest product quality and assure compliance to internal procedures and applicable external standards and regulations.

 

Position Responsibilities:

  • Supports implementing containment and mitigation actions while driving timely disposition of non-conforming products
  • Conducts root-cause analysis using defined methodologies including identifying appropriate corrective and preventive actions and establishing effectiveness plans.
  • Supports production and process change control through review and approval of documentation, ensuring adequacy of verification or validation to support the change, good documentation practices and compliance to procedures.
  • Generates, reviews and approves quality system documents including manufacturing process updates, non-conformance related documentation, process and equipment qualifications, and change orders
  • Supports assessment of tooling and equipment issues for impact on manufacturing processes, product, and compliance to requirements.
  • Reviews and analyzes quality trends with the manufacturing team and recommends actions for process, equipment and system improvement
  • Provides guidance to sustain quality/compliance and improve cell efficiency; monitoring and controlling areas of responsibility for compliance to Quality System Requirements and procedures.
  • Coordinates with customer facilities and internal engineering resources to respond to customer facility questions and resolve complaints.
  • Participates in audit/assessment of manufacturing operations, and recommends corrective/preventive actions and process improvements.
  • Communicates significant issues or developments identified during quality activities and participates in process improvements to instill rigor in process and product.
  • May participate in development projects to ensure products and processes are designed, developed and transferred to meet appropriate requirements.

 

Basic Qualifications:

  • Bachelor's degree in engineering, science, or other technical discipline

 

Preferred Qualifications:

  • 1+ years of quality, reliability or product support engineering experience.
  • Bachelor's or Master's Degree in Engineering, Material Science or related field
  • Working knowledge of process improvement skills including Six Sigma, Lean Sigma, Knowledge Management and Process Design.
  • Engineering tools utilization experience such as design of experiments, risk management, validation, methodical problem solving and statistical analysis.
  • Experience supporting manufacturing automation and IT systems.
  • Strong analytical and problem-solving skills and experience applying these skills to resolve quality problems in a manufacturing environment.
  • Ability to work effectively in a team environment with a diverse group of people
  • Works well in a fast-paced environment.
  • Organized and able to attain results on several projects simultaneously.
  • Results-oriented.
  • Self-starter.
  • Good oral and written communication skills.
  • Computer experience is required; experience with a computer based production control system desired.
  • Working knowledge of applicable standards and regulations standards (including, but not limited to: ISO13485, MDD and 21 CFR 820).


Posted: October 19, 2018, 10:57 am
Category : Quality/Regulatory
Job Type : Contract
Id : 7528
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 interperetation 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 across the Cardiac Rhythm and Heart Failure business unit 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
  • Materials Science knowledge with an emphasis on 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 regulatory and device regulations for medical devices including biocompatibility and regulated materials.
  • 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.


Posted: October 19, 2018, 8:03 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 : Manufacturing Engineer
Job Type : Permanent
Id : 7525
Region : Twin Cities

Seeking a Senior Manufacturing Engineer to support 3D Automated Optic Inspection (AOI) sensor products. The Senior Manufacturing Engineer has the responsibilities to continuously improve the performance of the manufacturing process by using continuous incremental improvements principles, specific projects, fixture discipline development, and continual evaluation of performance over time.

Key Responsibilities and Essential Functions:

  • Analyzing manufacturing process flows continually for the enhancements of quality, cost reduction, yield and throughput. Establish control plans for assigned products.
  • Work closely with NPD manufacturing engineering to not accept adhoc programs into the manufacturing processes. Be vocal and collaborate with engineering department to escalate production defects.
  • Conferring with assemblers, development and vendors in determining product specifications and arranging equipment, fixtures, parts, and evaluating products according to quality standards and specifications.
  • Define metrics and report results of manufacturing fixture yields and plans for improvement. Including identification of product yield, scrap cost, and rework to achieve continuous improvements for the factory.
  • Specify design criteria for manufacturing technologies and concepts. Provide reproducibility and manufacturing expertise for new product development activities and the design to production transition processes. Including designing and developing manufacturing processes for enhancements, product changes, new products, and related fixtures and tooling that are consistent with zero defect level and low product cost.

Experience, Education, and Competencies Required:

  • Bachelor’s degree in an engineering or related field.
  • Minimum of 7+ years of experience in a manufacturing environment or 5 years of experience with a Master’s Degree.
  • Ability to work effectively with cross-functional groups and ownership for products and processes assigned.
  • Experience with fixturing, knowledge of optical, electrical and mechanical assembly.
  • Experience in statistical applications tools such as Minitab, Excel, or JMP.

Experience, Education, and Competencies Preferred:

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



Posted: October 16, 2018, 9:53 am
Category : Electrical Engineer
Job Type : Permanent
Id : 7524
Region : Twin Cities

We have an excellent opportunity for a Senior Electrical Firmware Engineer. The successful candidate will engage as a leader of a highly technical and energized development team, performing and leading electrical engineering design and development. The leadership progression will be to start as a team leader and progress to a manager pending the candidate’s potential.

Essential Job Functions:

  • Provide technical leadership to electrical engineering team members, including instructing and verifying team members’ work.
  • Create firmware and software algorithms for embedded systems, applications, and PC based programs for end products, test systems, and subsystems.
  • Mentor and lead junior engineers and interns. Give work direction and performance feedback.
  • Troubleshoot and evaluate existing algorithms.
  • Develop specifications for electronic products, assemblies, and parts.
  • Design, integrate, and document a variety of electrical concepts, prototypes, and products.
  • Familiar and comfortable with designing PC boards, performing layout, and reviewing boards after fabrication.
  • Assist in the writing and create engineering proposals for new projects and programs.
  • Show flexibility by performing various engineering tasks and working on multiple concurrent design projects.
  • 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.
  • Meet with new and current Customers to understand design specifications, schedules and budgets.
  • 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.

Education

  • BS degree w/5-10 years of experience
  • MS degree w/3-7 years of experience

Experience/Qualifications

  • Experience in the complete product development process, including design and project definition, development, testing, and on-time execution.
  • Firmware Engineering expert (creating, troubleshooting, and editing embedded firmware or software. Able to read and write simple scripts or software programs)
  • Hardware Engineering experience (design, schematic, layout, integration, BOM, ECR / ECO, test, and qualification).
  • 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.
  • 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.
  • Wireless development including IoT.
  • This position has minimal travel requirements (up to 10%).
  • Ability to work cross-functionally with other engineering disciplines



Posted: October 15, 2018, 6:49 am
Category : Quality Engineering
Job Type : Contract
Id : 7523
Region : Twin Cities

The Operations Quality Engineer will provide operations quality and support for European Medical Device Regulation (EU MDR) assessment and risk management remediation (PFMEA) for Medical Device products, provide engineering expertise on cross-functional teams and collaborating with other company and external engineering groups.

This candidate will have a strong operations quality assurance background, must be able to work in a team environment and be able to communicate clearly across all disciplines including Operations, Research & Development, Regulatory Affairs, and Outside Partners and Regulatory Agencies.

 

Position Description:

  • Collaborates with engineering and manufacturing functions to ensure quality standards are in place.
  • Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.
  • Strong working knowledge of EU Medical Device Regulations, FDA Guidance Documents and Industry Standards.
  • Provide engineering review of current quality system documentation to the EU MDR requirements.
  • Strong working knowledge of medical device risk management in compliance with 14971:2012.
  • Lead, coordinate, execute, and document system analysis.
  • Strong collaboration and influence skills (build relationships, leverage others, align and work towards shared outcome-based goals, understand others' needs, negotiate for win-win).
  • Working knowledge of PPAP, CQP and supplier quality management.
  • May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality.
  • Communicates primarily with internal contacts within immediate group.
  • Contacts others to gather, confirm and convey information.

 

Posted: October 11, 2018, 1:37 pm
Category : Technician - General
Job Type : Contract
Id : 7522
Region : Twin Cities

Seeking an experienced Technician to perform the following duties:

  • Variety of duties in the electronic, mechanical, electro-mechanical 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.
  • 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 formulas and procedures, and performs detailed mathematical calculations.

Required Knowledge and Experience:

  • Mechanical Aptitude
  • Familiarity with Medical Device Manufacturing quality system requirements
  • Ability to work independently
  • Requires complete and broad knowledge of operational systems, techniques and practices.
  • Requires minimum of 4 years of relevant experience


Posted: October 11, 2018, 1:25 pm
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 : Technicians
Job Type : Contract
Id : 7518
Region : Twin Cities

Seeking a Calibration Technician who has worked in a calibration lab for a minimum of 2 years and has experience performing general physical/dimensional calibrations (e.g. torque, pressure, force, torque, etc.) This individual should be able to perform calibrations from a calibration procedure. Minimum 2 years calibration experience, military calibration training preferred but not required.



Posted: October 8, 2018, 1:27 pm
Category : Reliability Engineer
Job Type : Contract
Id : 7517
Region : Twin Cities

As a Senior Reliability Engineer, this position is expected to serve as an independent technical leader with a strong grasp of engineering standards, technical principals, theories, concepts and tools along with general knowledge of other related disciplines.

POSITION RESPONSIBILITIES:

  • Experience with risk management (Hazards/Harms, and DFMEAs)
  • Some statistics knowledge (able to perform reliability time to failure analysis such as Weibull, Kaplan Meier, and Binomial)
  • 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.
  • Plan, lead, and execute test and assessment activities, to demonstrate product performance and compliance.
  • 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.).
  • Lead cross-functional teams in the preparation of 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.
  • Communicate to key stakeholders, including external regulatory agencies, regarding fielded product with potential quality issues.
  • Provide support to internal and external audits.

EDUCATION REQUIRED:

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

DESIRED/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: October 8, 2018, 10:55 am
Category : Test Engr - Technical
Job Type : Permanent
Id : 7516
Region : Twin Cities

Seeking a Mechanical Test Engineer to assure product performance by designing and developing test cases and plans, identifying failures and causes of failures & developing solutions.

 

Essential Functions:

  • Develop product testing approaches by researching, analyzing, selecting, and applying test engineering concept approaches, techniques, and criteria; adapting and modifying test engineering options; developing and evaluating test methodologies.
  • Develops and maintains product test evaluation program by preparing timetables, cost estimates, and required resources including test laboratories, personnel and equipment.
  • Identifies product failures by establishing test standards, methods, test environment; analyzing and evaluating findings and failures; identifying root causes.
  • Documents test studies by recording test results; preparing reports; and maintaining test database.
  • Meet customer demands in a timely fashion.
  • Setup of design of experiments (DOE).
  • Subject matter experience in the areas of injectable and inhalable drugs/biologics.
  • Subject matter experience in electronic devices and design control compliance is a plus.
  • Subject matter experience in test plan development.
  • Extended travel to other facilities may be required to support business needs.

               

Required Qualifications:  

  • Bachelor of Science Mechanical or other Engineering field with an MS preferred
  • 2+ years test engineering in a similar industry/test lab (electro-mechanical testing/med device industry).

 

Skills and Abilities:

  • Strong understanding of test standards, equipment and test lab methodologies.
  • Preferred Medical Device Experience.
  • Exposure to Material Testing.
  • Competence in static and cyclic testing; data acquisition.
  • Demonstrate track record of planning activities with contingency actions.
  • Demonstrate strong written, verbal and interpersonal and communication skills.
  • Working proficiency of Microsoft Excel and Visual Basic Programming; experience with LabView programming desired.
  • Strong understanding of test methods validations for Design Verification Testing.
  • Demonstrated knowledge of the medical device product development processes and testing needs to support those development processes.


Posted: October 8, 2018, 6:56 am
Category : PC Board Designer
Job Type : Contract-to-Hire
Id : 7515
Region : Twin Cities

PCB Layout/ECAD Technicians work with cross-functional teams and Electrical Engineers to layout printed circuit boards. This involves translating schematics and incorporating component requirements into a board layout that is manufacturable, functional, and EMC compliant.

Essential Duties & Responsibilities:

  • Layout and placement of PCB.
  • Tool maintenance and support.
  • Library development assistance as needed.
  • ECAD system schematic entry assistance as needed.
  • PCB assembly documentation, development, and review
  • Assist with other technical tasks as requested.

Qualifications:

  • ECAD proficiency in Altium is required
  • 2-year technical degree or higher preferred
  • 2+ years technical experience, preferably in the medical, military or avionics industries.
  • Mechanical CAD (SolidWorks) experience would be a plus.
  • Mechanical skills associated with incorporating PCBs into larger assemblies.
  • Ability to create drawings and write detailed, compliant technical documents.
  • Strong analytical and problem-solving skills.
  • Results-oriented with a bias for action and timely completion.
  • Strong interpersonal, teamwork, and communication skills.
  • Employees are expected to contribute to our team while enhancing their own technical expertise and increase their responsibilities. They are also encouraged to be creative and innovative, while at the same time are expected to learn and enhance their skills.



Posted: October 5, 2018, 1:02 pm
Category : Packaging Engineer
Job Type : Contract
Id : 7514
Region : Twin Cities

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

Position Responsibilities:

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

Basic Qualifications:

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

Preferred Qualifications:

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


Posted: October 5, 2018, 10:21 am
Category : Technician - Medical Equipment
Job Type : Contract
Id : 7507
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: September 27, 2018, 6:06 am
Category : Quality Engineering
Job Type : Contract
Id : 7506
Region : Twin Cities

Seeking a Supplier Quality Engineer for a leading medical device company. This position entails developing and implementing technical solutions for product acceptance of product sourced from suppliers. Involves working closely with several other functions, including Sourcing, Supplier Quality, Reliability and Regulatory in a global environment.

Position Responsibilities

  • Responsible for Supplier Quality Management (SQM) implementation at suppliers and internal company facilities.
  • Identify customers’ needs and determine and develop technical solutions to meet those needs.
  • Work on cross-functional teams to drive SQM projects to support Business Unit objectives.
  • Partner with Category Management, Source Engineering, Site Supplier Quality and Suppliers to ensure the project strategy is fully aligned in expectations and plans.
  • Represent SQM strategies, communicate constraints and progress at cross functional business reviews and planning sessions.
  • Proactively drive supplier quality improvements related to SQM Deployment.
  • Responsible for processing and approving process change notices.
  • Provide system support to monitor supplier performance and drive effective corrective and preventative action
  • Interface with IT and Shared Service groups to determine systems enhancements, and define/work projects.
  • Work in close liaison with Pre-Market SQE / NPD Teams
  • Responsible for execution of validation for SQM to satisfy both regulatory and internal company requirements, including the preparation of high quality protocol and reports.
  • Performs timely investigations into SQM issues
  • Supports Quality Engagement with Sourcing for technical rigor & independent approvals.
  • Anticipate roadblocks, provide direction for navigating the quality system and supporting applications. Work in a cross-functional, collaborative, team-based environment; work with multiple sites in various locations and time
  • Serve as a technical resource for problem investigations; Support failure analysis of any product failures and associated corrective actions using both internal and external resources to guide root cause analysis and corrective action development.
  • Applies understanding of statistical concepts in conduction of validations.

Basic Qualifications:

  • 3+ years relevant experience with a Bachelor’s degree; Bachelor’s degree in Engineering, Chemistry, Physics, Materials or technical discipline

Preferred Qualifications:

  • Supplier Quality Management system or SPACE experience
  • Software Systems deployment experience
  • Experience working with vendors and suppliers from quality standpoint
  • Process / manufacturing engineering experience
  • Statistical data analysis such as inspection/GD&T/Gage R&R and experience using Minitab
  • Experience working in regulated industry like medical devices
  • Proven problem solving skills, root cause analysis
  • Excellent interpersonal and written communication skills
  • Technical writing experience
  • Systems deployment experience
  • Use of Excel, Access, Sharepoint and sitebuilder


Posted: September 26, 2018, 2:48 pm
Category : Technician - R&D
Job Type : Contract
Id : 7505
Region : Twin Cities

Seeking a Technician to provide technical support in production, operations, maintenance, safety, testing, process improvement or product development. This position 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

 

Position Duties:

  • Performs a variety of electronic and mechanical duties
  • 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.

 

Position Requirements:

  • Requires minimum of 4 years of relevant experience

 

Posted: September 26, 2018, 12:08 pm
Category : R&D Engineer
Job Type : Contract
Id : 7504
Region : Twin Cities

Seeking a R&D Engineer to develop engineering solutions for new and existing medical device products through cross-functional interaction. This position will provide recommendations based on in-depth analysis. May lead projects within job area and may provide work direction to other employees within job area.

 

POSITION RESPONSIBILITIES:

  • Proven experience executing product changes regulated by design control.
  • Proven experience applying product development process to a derivative product line.
  • Understands the requirements of cross-functional internal customers.
  • Understanding and wide application of technical principles, theories and concepts in the field.
  • Participates in preclinical evaluations.
  • Good clinical indications experience.
  • Observation and good understanding of human clinical procedures.
  • Responsible for subset of product design.
  • Develops product specs, test methods, equipment.
  • Creates, reviews and approves protocols/reports.
  • Interprets test results.
  • Working knowledge of DRM and statistics.
  • Responsible for subsystems of designs or smaller designs in their entirety.
  • Completes tasks associated with area of responsibility within assigned schedule.
  • Solid understanding of regulatory indications and requirements, such as IDE, 510k, PMA's, contributes to assigned sections of submission documents.
  • Working knowledge of internal quality system (e.g. SOPs, DOPs), external quality standards, and statistical methods.

 

BASIC QUALIFICATIONS:

  • Bachelor's degree in Mechanical Engineering/ Materials Science / Chemical Engineering, or related technical field
  • 4+ years of relevant experience with BS, 2+ years with MS, 0+ years with PhD
  • Experience developing products and/or processes
  • Demonstrated problem solving skills
  • Demonstrated verbal and written communication skills
  • Demonstrated leadership and initiative

 

PREFERRED QUALIFICATIONS:

  • Experience with medical device-based products, processes and technologies
  • Medical Device / Pharmaceutical or other regulated Industry experience
  • Background in Metals design and processing

 

Posted: September 26, 2018, 10:06 am
Category : Technician - Medical Equipment
Job Type : Contract-to-Hire
Id : 7503
Region : Twin Cities

 

Immediate need for Electronics Technician to support new product development of medical device products. This includes supporting development engineers in prototype build and test, test fixture design and build, and project documentation. Prefer AS degree in Electronic Technology, and 2+ years of experience in supporting electronic product development, and prefer experience in medical device procedures and documentation. Will consider junior and more senior level candidates. Must be proficient in soldering, PCB prototyping, surface mount and through hole technology, reading schematics, and component level test and troubleshooting using standard test equipment, including power supplies, waveform generators, oscilloscopes, spectrum analyzers, DMMs, etc.



Posted: September 26, 2018, 8:55 am
Category : Technician - General
Job Type : Contract
Id : 7502
Region : Twin Cities

Seeking an Electrical Design Technician to provide technical support in product development for Design Characterization testing and Design Verification Testing. Execute test plans, troubleshoot issues, and collaborate with team to drive project to completion. Use schematics, diagrams, written and verbal descriptions or plans to perform testing and troubleshooting on electronic devices, or test systems. Gathers, maintains, formats, compiles, and manipulates technical data using established procedures. May suggest and/or make improvements to optimize work processes. Must have good soldering skills, good troubleshooting skills, and an understanding of the medical DVT process.



Posted: September 18, 2018, 12:39 pm
Category : Packaging Engineer
Job Type : Contract
Id : 7500
Region : Twin Cities

Seeking a Packaging Engineer to be responsible for the qualification of sterile barrier packaging, updates to engineering drawings, updates to labeling specifications, and support of the packaging team members to complete project tasks.

MAIN JOB DUTIES/RESPONSIBILITIES:

  • Responsible for the qualification of existing packaging systems through EO sterilization
  • Responsible for collaborating with a cross functional team to determine qualification, testing and documentation requirements
  • Manage multiple tasks to meet timelines
  • Responsible for evaluation of materials, design, and configuration of primary, secondary, and other packaging to optimize customer benefit, operations requirements, and the supply chain requirements
  • Draft technical documentation including package testing protocols and validation associated with the qualification of packaging designs
  • Perform other related activities and special projects as needed

JOB QUALIFICATIONS

  • Bachelor’s degree in Packaging Engineering or equivalent engineering degree
  • 2+ years packaging engineering, or related field
  • Experience working in a team environment
  • Familiarity or experience with EO sterilized packaging
  • Effective verbal and written communication, analytical, influencing and interpersonal skills
  • PC skills, word processing, spreadsheets, project management, etc.
  • AutoCAD/Solidworks CAD software knowledge and experience


Posted: September 18, 2018, 9:26 am
Category : Technicians
Job Type : Contract-to-Hire
Id : 7492
Region : Twin Cities

Immediate opportunity for an experienced Machine Builder/Service Technician on the first shift.

 

Responsibilities:

  • Assembling, testing, crating and installing custom industrial machines. 
  • Primarily this will be assembling mechanical and pneumatic components for machines but will include some electrical assembly as well.
  • It will also include testing machines to see that they are functioning correctly and meet the criteria set out in the machine testing procedure.
  • Crating the machines to ship to facility
  • The candidate must have a willingness to travel about 15% to perform machine installations and operator training. 

 

Qualifications and Skills:

  • Must have the ability to read and interpret engineering assembly drawings and schematics and provide your own hand tools. 
  • The candidate must be a self-starter. 
  • Qualified candidates should have some vocational school training and/or machine building experience including familiarity with PLC/HMI controls.  

 

Posted: September 12, 2018, 10:03 am
Category : Quality/Regulatory
Job Type : Contract-to-Hire
Id : 7493
Region : Twin Cities

Unique opportunity for a high-energy Document Coordinator who is able to confidently interface at all organizational levels both internally and externally within an engineering and production environment.

Candidate must: be quality oriented and willing to promote quality standards and adherence to process and procedure; maintain confidentiality of sensitive materials; work independently and hold strong time management skills; be resourceful, flexible, productive and results-driven; display rigor and a strong attention to detail and accuracy; be dedicated and focused on the integrity and success of the business; have the ability to multi-task and complete daily, weekly, monthly, and as needed assignments within allotted timelines.

Administrative Support:

  • Perform tasks and maintains roles and responsibilities per the mandatory requirements of the Quality Assurance department and per the business Quality Management System.
  • Perform ad-hoc tasks and assignments per the direction of the Director of Operations and Quality.
  • Support office operations as necessary.
  • Provide back-up to the receptionist as needed.

Documentation Support:

  • Organizes and maintains filing systems of operational and confidential information.
  • New project document set-up and design documentation handling.
  • Customer documentation packages and project shipping documentation handling.
  • Engineering change order (ECO) processing.
  • Standard work procedure (SWP) processing.
  • Internal Project Assessment (IPA) set-up.
  • Calibration and preventive maintenance tracking and Tool record keeping.
  • Performs filing and scanning of quality system documentation.
  • Creates and submits Laser Reports.
  • Conducts weekly and as-needed audits and cycle counts.
  • Initiates and tracks new/continued training compliance records for all employees.
  • Management of non-conforming project materials throughout project life cycles.

Qualifications:

  • Must be detail-oriented and possess strong organizational and time management skills with the ability to prioritize and manage the completion of multiple tasks and projects.
  • Excellent verbal and written communication skills.
  • Demonstrated proficiency with the most current versions of Adobe PDF and Microsoft Office, including Word, Excel, Power Point, Outlook & Access.
  • Demonstrated ability to work with all levels of employees within organization.
  • Strong customer focus, excellent service skills, and positive, “can-do” attitude.
  • Knowledge of ISO and GMP regulations desired.
  • 2 or 4 year degree Business Administration or related field or equivalent prior experience.



Posted: September 11, 2018, 11:56 am
Category : Controls Engineer
Job Type : Contract
Id : 7491
Region : Twin Cities

The ideal Controls Engineer candidate will be a contributing team member in the conceptual development, design, implementation and commissioning of control and data acquisition for aerodynamic ground test facilities, turbine engine test cells and wind tunnels. The Controls Engineer will work directly with external and internal customers to evaluate project requirements, provide solutions as necessary, offer design reviews and assist with system installations.

Responsibilities:

  • Assume Lead Controls Engineer responsibilities for assigned projects to include, defining design requirements, leading and mentoring other engineers and designers, coordinating with engineers from other departments, and reporting progress to the Project Manager
  • Prepare design calculations, reports and specifications
  • Oversee development of engineering drawings
  • Specify and size control devices
  • Support system procurement, fabrication and installation
  • Perform field commissioning and acceptance testing
  • Assist in development of proposals, including scope, budget, and schedule

Desired Experience:

  • Demonstrated experience as a Lead Controls Engineer on a project
  • Design of electrical process control systems and integration of instruments
  • Electrical control system wiring design
  • Control and integration of electrical-mechanical valves
  • Design of data acquisition systems
  • Control system field installation and check-out
  • Design of precision pressure and temperature control loops
  • Experience with control system simulation and tuning of complex PID control system
  • Proficient in PLC and LabView programming
  • A broad background in control theory, instrumentation and hardware

Education and Requirements:

  • Bachelors of Science Degree in Electrical Engineering, Controls Engineering or related degree
  • 4+ years of progressive work experience
  • 10% travel


Posted: September 7, 2018, 8:14 am
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 : Electrical Engineer
Job Type : Permanent
Id : 7463
Region : Twin Cities

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

 

JOB RESPONSIBILITIES

Design:

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

Product Planning:

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

 

JOB REQUIREMENTS

  • B.S. in Electrical or Electronic Engineering with 2+ years related experience.
  • Understanding in ISO quality standards.
  • Familiarity with interpretation/creation of wiring schematics
  • Experience with electronic test equipment such as oscilloscopes, signal generators, signal analyzers, etc.
  • Understanding of GD & T
  • Experience with Autodesk Inventor and AutoCAD.
  • Experience with ERP manufacturing software (IQMS preferred).
  • Experience with the design and manufacturing of electrical slip rings and/or other electronic components
  • Plan and organize own workload, able to multitask
  • Solve problems with minimal direction.
  • Communicate effectively within the organization, in addition to customers and suppliers.
  • Work cooperatively with other employees



Posted: August 24, 2018, 1:21 pm
Category : Electrical Assembler
Job Type : Contract-to-Hire
Id : 7471
Region : Twin Cities

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

RESPONSIBILITIES:

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

REQUIRED:

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

DESIRED:

  • Knowledge of UL508A standards


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

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

Position Responsibilities:

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

Must Have Skills and Experience:

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

Highly Desired Skills and Experience:

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


Posted: August 15, 2018, 8:07 am
Category : Electrical Engineer
Job Type : Permanent
Id : 7446
Region : Twin Cities

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

Essential Duties and Responsibilities:

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

Qualification Requirements:

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


Posted: July 24, 2018, 12:13 pm
Category : Project Manager
Job Type : Permanent
Id : 7440
Region : Twin Cities

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

Major Areas of Accountability:

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

Position Requirements:

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


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

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

 

Major Areas of Accountability:

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

 

Qualifications:

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

 

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

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

Responsibilities:

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

Qualifications:

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


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

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

ESSENTIAL RESPONSIBILITIES:

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

POSITION REQUIREMENTS:

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


Posted: July 10, 2018, 10:19 am
Category : Technicians
Job Type : Permanent
Id : 7431
Region : Twin Cities

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

Qualifications & Experience:

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



Posted: July 9, 2018, 11:19 am
Category : Software Engineer
Job Type : Permanent
Id : 7413
Region : Twin Cities


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

 

POSITION RESPONSIBILITIES:

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

MINIMUM QUALIFICATIONS:

  • BS or BA in Computer Science, Software Engineering, Math, or other related science or engineering discipline
  • 3 years directly applicable experence working with desktop engineering, scientific, or computational-based applications
  • 5 years experience using C++ as primary development language (70% of work)
  • 1 year of front-end development experience using JavaScript (20% of work)
  • 3 years experience using C#, .NET, and Microsoft development tools and envirionment (10% of work)
  • 3 years utilizing effective object-oriented design principles

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


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


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

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


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


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

 

Essential Duties and Responsibilities:

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

 

Basic Qualifications:

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

 

Preferred Qualifications:

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


Posted: June 20, 2018, 1:54 pm
Category : Systems Engineer
Job Type : Contract
Id : 7394
Region : Twin Cities

Seeking a Principal Systems Engineer to provide engineering leadership in the design and development of innovative products for Medical Devices through technical planning, system level evaluation, verification and validation. To provide engineering expertise on cross-functional development project teams and collaborate with other external engineering groups.

Responsibilities Include:

  • Fluid system development defining the fluid circuits to support hemodialysis and peritoneal dialysis system
  • Provide engineering expertise in cross functional teams conceiving, evaluating and developing new white space opportunities
  • Develop solid understanding of targeted therapies and clinical applications
  • Ensure that device concepts and development plans meets targeted clinical application through systematic conversion of product requirements into total systems solutions that acknowledge technical, schedule, and cost constraints.
  • Lead, coordinate, execute, and document system analysis and design activities, including but not limited to security, safety, reliability, risk, usability and interface management
  • Establish and advocate for best practices and continuous improvement to mature the Systems Engineering knowledge and processes (CoE)
  • Generate and approve requirements and specifications for all aspects of product concept; ensure that all systems are developed in harmony and support each other.
  • Establish system verification and validation plan(s)
  • Plan and execute system level validation through pre-clinical evaluation.
  • 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 these teams
  • Identify, and lead collaborations with internal and external engineering groups
  • Collaborate with quality and regulatory colleagues to ensure compliance
  • Participate in the identification and resolution of complex system issues through interfacing with engineers representing other components
  • Design, simulate and construct prototype devices for animal and human studies
  • 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.
  • Propose and champion new device concepts

Position Requirements:

  • 8+ years of experience with a Bachelor's Degree in a technical/engineering discipline; or
  • 6+ years of experience with a Master's Degree in a technical/engineering discipline; or
  • 4+ years of experience with a PhD in a technical/engineering discipline
  • Development of fluid circuits using pumps, valves, and sensor
  • Solid understanding of fluid circuit control systems

Nice to Have:

  • Significant breadth of knowledge in Quality, project planning, technical expertise, and all areas of product development.
  • Knowledge of dialysis device operation
  • Knowledge of FDA regulations and TÜV requirements


Posted: June 12, 2018, 2:41 pm
Category : Technicians
Job Type : Contract-to-Hire
Id : 7393
Region : Minnesota

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

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


Posted: June 12, 2018, 6:24 am
Category : Electrical Designer
Job Type : Contract-to-Hire
Id : 7355
Region : Twin Cities

Seeking an AutoCAD Controls Designer to perform the following:

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

 

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

Seeking a Senior Engineering Technician for the following duties:

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


Posted: April 30, 2018, 1:10 pm
Category : 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
Category : Electrical Power & Lighting
Job Type : Permanent
Id : 7122
Region : Twin Cities

Qualifications / Requirements:

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

Responsibilities:

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


Posted: October 25, 2017, 8:06 am
Category : Electrical Engineer
Job Type : Permanent
Id : 6992
Region : Twin Cities

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

 

Position Requirements:

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

 



Posted: June 28, 2017, 11:34 am