Sr. R&D Engineer - Medical Device (Onsite - Maple Grove, MN) Contract
PharmaviseMaple Grove, MN, United States- Full-time
Job Description
Our Fortune 500 Medical Device client has an exciting opportunity for a Sr. R&D Engineer.
Job Summary :
We have an exciting opportunity for Senior R&D Engineer within the 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.
Key Responsibilities :
- Test Method Development
o Design, develop, and document new test methods to support product verification
o Evaluates the appropriateness and applicability of the test method to measure the specification.
o Create test instructions following company work instructions and applicable standards (ISO 10555, 21 CFR 820.30, ISO 13485, etc).
o Evaluates the measurement accuracy and precision against the tolerance requirements.
o Apply risk-based thinking to identify potential sources of variability or error in test methods.
o Incorporate controls that ensure measurement accuracy, repeatability, and reproducibility.
o Evaluate and mitigate risks related to equipment, operator execution, and environmental factors.
o Collaborate with R&D, Design Engineering, Packaging Engineering and Quality teams to align test methods with product design inputs and requirements.
o Interpret product design intent to establish relevant test criteria and tolerances.
o Assess the impact of design or process changes on existing test methods and update documentation accordingly.
o Support test method validation activities via Design Quality.
o Ensure compliance with internal SOPs, regulatory requirements, and Good Documentation Practices (GDP).
o Maintain test method traceability to design specifications, risk analyses, and verification plans.
o Ensures test equipment and instruments are calibrated and qualified, if applicable.
o Partner with Subject Matter Experts (SMEs) for advanced statistical or scientific method development.
o Train laboratory staff and test users on proper execution of validated test methods.
o Provide technical guidance on equipment calibration, setup, and safety requirements.
Required Qualifications :
Preferred Qualifications :
Other Details :
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