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CERENE cryotherapy device by Channel Medsystems · 1 day ago

Principal Mechanical Engineer

Berkeley, CA

Full-time

Onsite

Lead/Staff

15+ 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 Principal Mechanical Engineer will manage a multi-year COGS reduction program and oversee the establishment of in-house manufacturing for critical subassemblies while ensuring compliance with industry standards.

BiotechnologyHealth CareMedical DeviceWomen's

Responsibilities

Manage a multi-year COGS reduction program having Board level visibility

Establish in-house manufacturing for a critical subassembly

Outsource & qualify high-volume component suppliers

Develop supplier capabilities as required

Implement design & process changes to further reduce costs

Create & manage detailed project plan, balancing competing priorities

Bench test & characterize component & subassembly performance

Hire and manage consultants with technical expertise

Oversee design, construction & installation of high-pressure control system

Specify, purchase & qualify other necessary production equipment

Define compliance program to meet industry standards

Write manufacturing process instructions & train operators

Write & execute V&V test protocols and reports

Create documentation for DHF, Technical File, and regulatory filings

Support regulatory filings & quality audits

Lead brainstorming, design review & risk management meetings

Contribute to Channel’s IP portfolio

Qualification

Mechanical EngineeringMedical Device ExperienceSolidWorksProgram ManagementRegulatory KnowledgeTechnical WritingInterpersonal SkillsCommunication Skills

Required

BS or MS degree in mechanical engineering or a related discipline

15+ years in medical device or another highly regulated industry

Program management of deliverables, timelines, resources, etc

Experience using SolidWorks & other design, analytical & prototyping tools

Working knowledge of 21 CFR Part 820 & ISO14971

Technical writing & documentation

Strong interpersonal & communication skills

Company

CERENE cryotherapy device by Channel Medsystems

Channel Medsystems is a women’s health medical device company advancing Cerene® Endometrial Cryotherapy, an in-office treatment designed to safely and effectively reduce heavy menstrual bleeding and dysmenorrhea while preserving access to the uterine cavity for future diagnostic evaluations.

Founded in 2009

Berkeley, California, USA

11-50 employees