Senior Research And Development Engineer
REQ SolutionsMaple Grove, MN, USjob_description.job_card.variable_hours_ago
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job_description.job_card.job_descriptionDesign, 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. 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. 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. 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. 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.
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 :
Risk Management & Controls :
Design & Technical Integration :
Validation & Compliance :
Education / Experience :
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Research And Development Engineer • Maple Grove, MN, US
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