POSITION SUMMARY

The Senior Quality Engineer will incorporate cross-functional project teams and contribute to product specification development and quality planning activities. Responsibilities include authoring and managing documentation for design verification and validation, software and process validations, human factors, and risk analysis. Lead the analysis of complaint and ensure compliance with quality management systems and regulatory requirements. Supporting production by troubleshooting issues and improving yields, collaborating with contract manufacturers to resolve issues, closing non-conforming material reports promptly, and ensuring adherence to internal procedures are crucial.

EDUCATION & EXPERIENCE:

• 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.
• Understanding of regulatory requirements for the medical device industry, specifically 21 CFR 820, ISO 13485, ISO 14971, and 21 CFR 11.
• Can be an equivalent combination of education and professional experience.

KNOWLEDGE, SKILLS, & ABILITIES:

• Proficiency with PC-based office computers, including familiarity with Microsoft Office suite required. Proficiency with statistical software, such as MiniTab, preferred.
• Strong foundation in education, skills in electrical and software engineering.
• Expert in tools and processes for root cause analysis.
• 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; enjoys the challenges of multitasking and working at a fast pace while staying flexible to shift tasks frequently.
• Ability to clearly write engineering justifications and analyses connecting product performance with compliance requirements.

PHYSICAL REQUIREMENTS:

• Travel required up to 10% of the time, including weekend and overnight travel.
• 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 salary offered will depend on several factors, including, but not limited to your experience, knowledge, skills, location, internal equity, and market alignment. Addition compensation may include bonuses and equity, along with a comprehensive benefits package.

JOB RESPONSIBILITIES

• Act as the Subject Matter Expert for QA for Design Control SOPs, DHF, Standards Compliance, and Design Transfer records. Support regulatory audits of Product Development function and outputs.
• Review, approve, and provide guidance for Design Verification and Validation activities, product and software traceability matrix.
• Responsible for quality engineering review of Document Change Orders for Product Development and Software update.
• 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. This includes testing for process validations, test method validation and data analysis.
• Lead CAPA generation, 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.
• 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.
• Partner with the Regulatory Affairs staff to ensure technical accuracy for domestic and international regulatory filings.
• Other duties as assigned.

WHAT IF YOUR WORK DOESN’T JUST SUPPORT INNOVATION—WHAT IF IT CHANGES LIVES?

At EBR Systems, Inc., we are not imagining that future—we are building it. We are the team behind the world’s first FDA approved, leadless left ventricular endocardial pacing device for heart failure. It’s a breakthrough redefining what’s possible in heart care, and it’s just the beginning!
We don’t just create game-changing medical devices—we grow people. Patients come first in everything we do. You will be empowered to solve real problems and to do meaningful work that truly makes a difference.
If you are driven by purpose, excited by challenge, and ready to shape the future of cardiac technology, we want to hear from you. Visit us at https://www.ebrsystemsinc.com/ to learn more—and join us in our work Empowering Physicians, Powering Hearts.