Senior Quality Engineer

Position Summary

The successful candidate will be a quality engineer with experience in the medical device industry who can demonstrate the ability to ensure that our suppliers meet all quality standards.

Job Responsibilities

• Execute supplier quality management program activities consisting of supplier monitoring, re-evaluation, and issues resolution through supplier corrective action requests, operations NCRs and audit findings.
• Author supplier audit plans, perform audits and create audit reports and monitoring metrics, present at appropriate review meetings.
• Aid in complaint handling investigation (perform investigations into manufacturing, design changes, etc), as assigned.
• Support production in troubleshooting issues and improving yields.
• Work with contract manufacturers to resolve issues, close non-conforming material reports, close supplier changes, close audit actions, and close supplier corrective actions in a timely manner, and ensure compliance with internal procedures.
• Quality Engineering review of Document Change Orders and Supplier Change Notices.
• Ensure suppliers on the ASL are current and required documents are on file.
• 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.
• 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.

Other Duties and Responsibilities

• Maintain state of the art technical knowledge.
• Other duties as assigned.

Education & Experience:

• BS in biomedical engineering or mechanical engineering
• Four years of related medical device experience
• Can be a combination of education and experience

Knowledge, Skills, & Abilities:

• Your understanding of regulatory requirements for the medical device industry, specifically 21 CFR 820, ISO 13485, ISO 14971, and EU MDR will enable you to properly audit and monitor suppliers.
• Ability to clearly write engineering justifications and analyses connecting product performance with compliance requirements.
• Proficiency with statistical software, such as MiniTab, preferred.
• Ability to work independently, using good judgment, initiative, and analytical abilities, to accomplish short and long-range projects, anticipate likely needs, and recommend actions with minimal direction.
• Ability to work as a team member and ability to be very flexible, adaptable, and to work under pressure.
• Self-motivated and self-directed; conscientious approach to work assignments.
• A valid driver's license is required to perform essential job functions as reliable, cost- effective, and timely travel cannot be achieved through alternative transportation methods. Compliance with applicable driving and state regulations is also mandatory.
• Required to stand, walk and sit; talk or hear; use hands to finger, handle or feel objects or controls; reach with hands and arms.
• Required to stoop, kneel, bend, crouch and lift up to 20 pounds. Specific vision abilities required by this job include close vision, distance vision, depth perception, color vision and the ability to adjust focus.
• Subject to extended periods of sitting and/or standing, vision to monitor, and moderate noise levels.

Salary Range: $126,700 - $163,000

*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, but not limited to experience, knowledge, skills, internal equity, and alignment with market data.

Disclaimer: EBR Systems Inc. will never ask for personal identifying information (such as Social Security Number, bank account details, or credit card information) during the application process. All communication from EBR Systems Inc. regarding job opportunities will be conducted through official company channels.

EBR Systems, Inc. does not accept unsolicited resumes from headhunters, recruitment agencies, or fee-based recruitment services. Please refrain from solicitations at this time.

About EBR Systems:

Silicon Valley-based EBR Systems is dedicated to superior treatment of cardiac rhythm disease by providing more physiologically effective stimulation through wireless cardiac pacing. The company's patented proprietary Wireless Stimulation Endocardially (WiSE) technology was developed to eliminate the need for cardiac pacing leads, historically the major source of complications and reliability issues in cardiac rhythm disease management.

We are a team of dedicated individuals, driven to deliver superior treatment of millions of patients suffering from cardiac rhythm diseases by developing safe, clinically superior, cost-effective, and reliable therapies using wireless cardiac stimulation. As a fast-paced company, every team member at EBR makes a big contribution towards our mission. 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 - relocation assistance is not available.

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
• 401(k) Bonus Program
• Life and AD&D Insurance
• Weekly company lunches and occasional happy hour events
• Meaningful work!