Description

As a Senior Quality Engineer, you will lead cross-functional project teams, contribute to product specification development, author documents for design verification and validation, process validations, lot release testing and risk analysis, and much more.

Are you curious, creative, and driven? If you are passionate about healthcare innovation, EBR could be the place for you. We seek candidates who are passionate about improving healthcare and motivated to do the hard and exciting work required to bring ground-breaking technology to market.

Please note – this is an on-site position. Relocation assistance is not available.

What you will do:

• Responsible for quality engineering review of Document Change Orders. 
• Determine quality improvement parameters for manufacturing processes. Work with various departments to ensure timely closure of CAPAs, NCRs, and complaints. Work with the R&D, Operations, Regulatory Affairs, and Sales and Marketing functions to coordinate release and/or hold of materials that have been segregated as non-conforming. Document nonconformances, including root cause and corrections.
• Determine test method validation requirements, create test method validation protocols, and document testing.
• Participate as CAPA owner, performing thorough root cause investigation and documenting corrective and preventative action plans. Ensure action plans are implemented in a timely manner.
• Evaluate significant product and/or process changes and enhancements which reduce defects, improve yields, and lower product cost. Proactively solve moderately complex problems at the product level.
• Create and document appropriate test methods and accurately generate complex written reports which include establishing statistical confidence by identifying sample size and acceptable error rates. This includes testing for process validations, test method validation, and design verification and validation.
• Work with Contract Manufacturers to ensure compliance to requirements and product quality and lead the resolution of product quality issues remediations.
• Assist with risk analysis activities and maintaining up to date risk management documents.
• Support company goals and objectives, policies and procedures, Quality System Regulation, and FDA/EU MDR regulations. Adhere to established company Quality System procedures, the Quality Policy, and work instructions. 
• Perform software validation.
• Other duties as assigned.

Requirements

Education & Experience:

• BS in biomedical engineering, or equivalent
• Minimum seven (7) years of experience is preferred, with related medical device experience.
• Understanding of regulatory requirements for the medical device industry, specifically 21 CFR 820, ISO 13485, ISO 14971, and EU MDR.

Salary Range:

$122,500 - $157,500

Base pay is one part of your total compensation. The final starting salary offer to the successful candidate will be determined by evaluating several factors, such as education, experience, knowledge, skills, internal equity, and alignment with market data.

About EBR Systems

Silicon Valley's EBR Systems is revolutionizing cardiac rhythm disease treatment with its WiSE™ CRT System technology, eliminating the need for pacing leads. Our dedicated team is committed to providing safe, cost-effective wireless cardiac stimulation therapies for millions of patients.

EBR Systems offers a great place to work as well as generous benefits and growth opportunities:

• Medical, dental, and vision insurance
• 401K
• PTO – starting at 3 weeks per year
• Competitive salary with opportunities for career growth
• Employee stock options
• Life insurance
• Weekly company lunches and occasional happy hour events