Job Description

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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