EBR Systems, Inc. is looking to solve quality engineering problems in the medical device industry, specifically in the development of cardiac technology, by incorporating cross-functional project teams and contributing to product specification development and quality planning activities.
Requirements
- Proficiency with PC-based office computers, including familiarity with Microsoft Office suite
- Proficiency with statistical software, such as MiniTab
- Understanding of regulatory requirements for the medical device industry, specifically 21 CFR 820, ISO 13485, ISO 14971, and 21 CFR 11
- Strong foundation in education, skills in electrical and software engineering
- Expert in tools and processes for root cause analysis
- Ability to clearly write engineering justifications and analyses connecting product performance with compliance requirements
- Experience with design control SOPs, DHF, and design transfer records
Responsibilities
- Act as the Subject Matter Expert for QA for Design Control SOPs, DHF, Standards Compliance, and Design Transfer records.
- Review, approve, and provide guidance for Design Verification and Validation activities, product and software traceability matrix.
- Perform firmware/software verification, regression, and integration testing: including testing software fixes, cybersecurity update and logging/tracking software defects.
- Create and design appropriate test methods, protocols and accurately generate complex written reports which include establishing statistical confidence by identifying sample size and acceptable error rates.
- Lead CAPA generation, performing thorough root cause investigation and documenting corrective and preventative action plans.
- Evaluate significant product and/or process changes and enhancements which reduce defects, improve yields, and lower product cost.
- Assist with risk analysis activities and maintaining up to date risk management documents.
Other
- BS in electrical, software Engineering, or equivalent biomedical Engineering with software engineering experience
- Minimum seven (7) years of experience is preferred, with related medical device experience
- Travel required up to 10% of the time, including weekend and overnight travel
- Ability to work independently, using good judgment, initiative and analytical abilities
- Ability to work as a team member and ability to be very flexible, adaptable, and to work under pressure
