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CERENE cryotherapy device by Channel Medsystems · 19 hours ago

Principal Software 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 Software Engineer will manage software projects, update embedded device control software, and support regulatory filings, contributing to the advancement of cryotherapy as a new standard of care.

BiotechnologyHealth CareMedical DeviceWomen's

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

Qualification

C programming languageSoftware integrationControl software for electromechanical systemsSoftware V&V best practicesProgram managementIEC 62304ISO14971Technical writingInterpersonal skillsCommunication skills

Required

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

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