Senior 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.

The ideal candidate is an experienced mechanical engineer who has supported the launch of an innovative medical device and successfully led efforts to reduce product costs and improve gross margin.

JOB DUTIES AND 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

• Perform root cause analyses on returned devices

• Lead brainstorming, design review & risk management meetings

• Support regulatory filings & quality audits

• Contribute to Channel’s IP portfolio

ESSENTIAL REQUIREMENTS

• BS or MS degree in mechanical engineering or a related discipline

• 10+ years in medical device or another highly regulated industry

• Program management & accountability for project deliverables & timelines

• Experience using Solid Works & analytical tools

• Working knowledge of 21 CFR Part 820 & ISO
14971

• Technical writing & documentation

• Strong interpersonal & communication skill

Please respond to:

• Resume

• Salary requirements

• Recent examples highlighting your experience and qualifications

Agency and Third-Party Recruiter Notice:

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 Medsystems is proud to be an Equal Opportunity Employer inclusive of disability and veterans.

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