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Senior Research And Development Engineer

Senior Research And Development Engineer

AkkodisMaple Grove, MN, United States
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Akkodis is seeking a Senior R&D Engineer for a 12+ Contract position with a client located in Phoenix, AZ

Pay Range : $60 / hr - $70 / hr ( The rate may vary based on experience, education, geographic location, and other factors. )

Position Responsibilities

We have an exciting opportunity for Senior R&D Engineer within Interventional Oncology and Embolization group. We are seeking a Test Method Development Engineer to support the creation, validation, and continuous improvement of test methods within our product development process. This role requires strong technical expertise in experimental design, risk control, and regulatory compliance. The successful candidate will ensure that test methods are scientifically sound, accurately measure product performance, and meet all applicable standards.

Your responsibilities include :

Test Method Development

  • Design, develop, and document new test methods to support product verification.
  • Evaluates the appropriateness and applicability of the test method to measure the specification.
  • Create test instructions following company work instructions and applicable standards (ISO 10555, 21 CFR 820.30, ISO 13485, etc).
  • Evaluates the measurement accuracy and precision against the tolerance requirements.

Risk Management & Controls

  • Apply risk-based thinking to identify potential sources of variability or error in test methods.
  • Incorporate controls that ensure measurement accuracy, repeatability, and reproducibility.
  • Evaluate and mitigate risks related to equipment, operator execution, and environmental factors.

    • Design & Technical Integration

  • Collaborate with R&D, Design Engineering, Packaging Engineering and Quality teams to align test methods with product design inputs and requirements.
  • Interpret product design intent to establish relevant test criteria and tolerances.
  • Assess the impact of design or process changes on existing test methods and update documentation accordingly.

    • Validation & Compliance

  • Support test method validation activities via Design Quality.
  • Ensure compliance with internal SOPs, regulatory requirements, and Good Documentation Practices (GDP).
  • Maintain test method traceability to design specifications, risk analyses, and verification plans.
  • Ensures test equipment and instruments are calibrated and qualified, if applicable.

    • Collaboration & Training

  • Partner with Subject Matter Experts (SMEs) for advanced statistical or scientific method development.
  • Train laboratory staff and test users on proper execution of validated test methods.
  • Provide technical guidance on equipment calibration, setup, and safety requirements.
  • Collaborate with cross-functional design team to support creation and documentation of Risk Management documentation such as Hazard Analysis, Task Analysis, Design Failure Mode and Effects Analysis, and Software Design Failure Mode and Effects and Analysis
  • Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
  • Advise management on potential improvements or enhancements to quality systems, processes, and products in the company.

    • Required Qualifications :

  • Bachelor’s degree in engineering, physics, math, or other science discipline, or equivalent.
  • Minimum of 4 years’ experience in design quality, R&D, or product development engineering in Medtech / regulated industry experience; or equivalent combination of education and experience
  • Understanding and demonstrated use of industry standards (e.g. IEC 60601, IEC 62304). within product design and development process
  • Strong ability to navigate ambiguous situations in a collaborative, innovative, and people-centric team environment.
  • Knowledge of key regulatory requirements including of ISO 13485 Quality Management Systems, ISO 14971 Risk Management, 21 CFR 820, and EU MDR.
  • Experience in Single Use Device (SUD) Development
  • Variable and Attribute Test method generation and validation experience
  • Prior exposure to risk management tools & methodologies such as hazard analysis, FMEA on detailed work with emphasis on accuracy and completeness
  • Ability to collaborate and work on a highly matrixed and global team
  • Experience with Class III Medical Devices

    • If you are interested in this Senior R&D Engineer job, then please click APPLY NOW. For other opportunities available at Akkodis go to . If you have questions about the position, please contact Sunny Kumar at Sunny.Kumar1@akkodisgroup.com.

    Equal Opportunity Employer / Veterans / Disabled

    Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, an EAP program, commuter benefits, and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable. Disclaimer : These benefit offerings do not apply to client-recruited jobs and jobs that are direct hires to a client.

    To read our Candidate Privacy Information Statement, which explains how we will use your information, please visit .

    The Company will consider qualified applicants with arrest and conviction records by federal, state, and local laws and / or security clearance requirements, including, as applicable :

  • The California Fair Chance Act
  • Los Angeles City Fair Chance Ordinance
  • Los Angeles County Fair Chance Ordinance for Employers
  • San Francisco Fair Chance Ordinance
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    Research And Development Engineer • Maple Grove, MN, United States