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Channel Medsystems · 1 hour ago

Senior Mechanical Engineer

Berkeley, CA

Full-time

Onsite

Senior Level, Lead/Staff

10+ years exp

Channel Medsystems is a privately held, commercial-stage company dedicated to transforming women’s healthcare through the development and commercialization of its flagship product, the Cerene® Cryotherapy Device. The Senior Mechanical Engineer will prioritize cost savings initiatives, manage supplier qualifications, and support the launch of innovative medical devices while ensuring compliance with regulatory standards.

BiotechnologyHealth CareMedical DeviceWomen's

Responsibilities

Prioritize and manage cost savings initiatives

Outsource & qualify high-volume component suppliers

Develop supplier capabilities as needed

Implement design & process changes to further reduce costs

Bench test & characterize component & subassembly performance

Update manufacturing process instructions

Write & execute V&V test protocols and reports

Update design documentation

Perform root cause analyses on returned devices

Troubleshoot device performance issues

Lead brainstorming, design review & risk management meetings

Support regulatory filings & quality audits

Contribute to Channel’s IP portfolio

Qualification

Mechanical EngineeringMedical Device ExperienceSolidWorksProgram ManagementRegulatory KnowledgeTechnical WritingInterpersonal SkillsCommunication Skills