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Senior Research And Development Engineer

Senior Research And Development Engineer

REQ SolutionsMaple Grove, MN, United States
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Job Title : Sr. R&D Engineer - Medical Device

Duration : 12+ Months (Possible extension)

Location : Maple Grove, MN 55311

Onsite Role

Responsibilities :

  • 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.
  • Will ensure that test methods are scientifically sound, accurately measure product performance, and meet all applicable standards

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.
  • Education / Experience :

  • Bachelor’s degree in engineering, physics, math, or other science discipline, or equivalent.
  • Min 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 ISO 13485 Quality Management Systems, ISO 14971 Risk Management, 21 CFR 820, and EU MDR.
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    Research And Development Engineer • Maple Grove, MN, United States

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