Principal Mechanical Engineer

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. Cerene provides gynecologists with an innovative solution for treating women suffering from heavy menstrual bleeding (HMB) and dysmenorrhea. The Class 3, FDA-approved procedure requires no capital equipment and can be performed in the convenience of a gynecologist’s office without general anesthesia or operating-room resources.

The Company is committed to advancing cryotherapy as a new standard of care to provide women a modern alternative to invasive surgery or long-term medications for the treatment of heavy menstrual bleeding.

This key position on the engineering team requires a high level of responsibility, self-motivation and commitment. The ideal candidate is an experienced mechanical engineer who has successfully implemented complex systems to scale‑up production, lower costs, and improve gross margin.

• 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

• 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 Solid Works & other design, analytical & prototyping tools
• Working knowledge of 21 CFR Part 820 & ISO
  14971
• Technical writing & documentation
• Strong interpersonal & communication skills

• Resume
• Salary requirements
• Recent examples highlighting your experience and qualifications

Agencies that submit a resume to Channel Medsystems must have a current Agreement executed by the company. In addition, Agencies may only submit candidates to positions for which they have been invited to do so by Channel Medsystems.

Channel Medsystems is an equal opportunity employer and consistent with federal, state, and local requirements. Channel Medsystems will consider requests for reasonable accommodation based on disability or sincerely held religious beliefs where it can do so without undue hardship for the company. Channel Med Systems is proud to be an Equal Opportunity Employer inclusive of disability and veterans.