What are the responsibilities and job description for the Principal Software Engineer position at CERENE cryotherapy device by Channel Medsystems?
Principal Software Engineer
Location: Berkeley CA – Office based
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 software professional with a proven track record of implementing embedded software for critical applications in highly regulated industries.
JOB DUTIES AND RESPONSIBILITIES:
- Manage software projects from concept through commercialization
- Write and execute software development plans
- Update embedded Cerene device control software
- Implement design changes to utilize lower-cost components & designs
- Bench test & characterize component, subsystem & complete device performance
- Analyze data & perform root cause analyses on returned devices
- Improve fault handling based on field data
- Coordinate software V&V activities
- Revise software requirements specifications, software design specifications, etc.
- Develop & maintain custom & 3 rd party software tools
- Update manufacturing test software
- Support regulatory filings & quality audits
- Maintain software issue tracking system
- Hire and manage software consultants as required
- Participate in brainstorming, design review & risk management meetings
- Balance competing priorities
- Contribute to Channel’s IP portfolio
ESSENTIAL REQUIREMENTS:
- BS or MS degree in an engineering, science or other technical discipline
- 15 years in medical device or another highly regulated industry
- C programming language expertise & best practices
- Software integration with TI MSP430 microcontrollers
- Control software for electromechanical components & systems
- Technical writing & documentation
- Working knowledge of IEC 62304, ISO14971 & applicable FDA Guidance documents
- Software V&V best practices
- Program management of deliverables, timelines, resources, etc.
- Strong interpersonal & communication skills
Please respond to: careers@cerene.com
- 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.