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Company

Original Job Post

Medical Engineering Consultants · 5 days ago

R&D Engineer III

Santa Clarita, CA

Contract

Onsite

Senior Level

5+ years exp

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Responsibilities

Ensuring all Design Controls aspects of an acquisition are remediated through: Developing new requirements, sourcing new requirements, creating and validating new test methods, creating new risk documentation, and performing all applicable testing

Supporting manufacturing moves from one vendor to another.

Supporting project work for EUMDR approval.

Maintains product safety, quality, and compliance of all products.

Trained in all aspects of change management (DCA, SCIA, SCAR, and PLCP).

Supports any applicable R&D projects planning and activities.

Understands and complies with all the regulations governing the quality system.

Supports additional activities required by the business.

Qualification

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Design controlsProject managementFDA regulationsISO 13485Quality assessmentCompliance impact assessmentDesign verificationValidation activitiesTest method developmentTroubleshootingRoot cause analysisMiniTabSolidWorksMedical device product developmentProblem-solvingSelf-motivated communicationElectro/MechanicalProduct DevelopmentManufacturing ProcessesSilicone MoldingLaser WeldingResistance WeldingSmall Part AssemblyCleanroom OperationsVision Inspection SystemsSolderingElectronic Component AssemblyElectrical TestingPackaging

Required

Bachelor’s Degree or equivalent with 5 to 8 years of experience. Master’s Degree or equivalent with 3 to 6 years of experience or PhD with 0 to 3 years of experience.

2+ years working with design controls.

2+ year project leader/manager experience.

2+ years working within FDA Quality System Regulations and ISO 13485.

Experience with assessing quality and compliance impact on products for design and process changes.

Experience with design verification and validations activities.

Experience with Test Method development.

Experience in troubleshooting and root cause analysis.

Self-motivated individual that can work independently.

Working knowledge of MiniTab and SolidWorks.

Good writing (assessments, protocols, reports, and email) and verbal communication skills.

Previous Medical Device Product development experience.

Preferred

Has led 4+ projects to drive product design changes or process changes preferred.

3+ years Electro/Mechanical experience.

Has participated in 4+ new product development projects, related product transfer and scale-up activities preferred.

Knowledge of manufacturing processes including silicone molding, laser welding, resistance welding, small part assembly, cleanroom operations, vision inspection systems, soldering, electronic component assembly, electrical testing and packaging.

SAP and Windchill experience are a plus.

Human Factors / Usability experience is a plus.

Sponsorship/ Corp to Corp is not available for this position.