Senior Manufacturing Quality Engineer

EBR Systems, Inc.; Sunnyvale (CA); On-site; USD 115,600 - 156,400; Full time

Benefits offered by this job

Medical, dental, and vision insurance

401(k) matching plan

Paid Time Off starting at 3 weeks per year

Employee stock options

Education assistance

Job summary

A leading medical device company in California is seeking a Senior Manufacturing Quality Engineer to drive quality initiatives and oversee automated measurement systems. The role demands expertise in inspection methodologies, process validation, and regulatory compliance in the medical device sector. Candidates should have a BS in Mechanical or Biomedical Engineering, complemented by four years of relevant experience. This position offers a competitive salary range of $115,600 - $156,400 and robust benefits including health insurance and 401(k) plans.

Qualifications

• Experience in the medical device industry with knowledge of 21 CFR 820 and ISO 13485.
• Strong technical writing and analytical skills for justifying engineering decisions.
• Ability to mentor and train inspection technicians.

Responsibilities

• Design, configure and maintain automated measurement systems.
• Support production by troubleshooting issues and improving yields.
• Lead quality improvement projects for EBR and supplier’s manufacturing processes.

Skills

Understanding of regulatory requirements for the medical device industry

Ability to write engineering justifications

Proficiency with MiniTab

Ability to work independently and as a team member

Flexibility and adaptability under pressure

Education

BS in Mechanical Engineering or Biomedical Engineering

Four years of related medical device experience

Tools

MiniTab

Solidworks

MasterControl

Job description

Overview

The Senior Manufacturing Quality Engineer will work cross functionally with manufacturing teams to drive continuous improvement initiatives. This role is responsible for designing and configuring automated measurement systems. The engineer will serve as a subject matter expert in inspection and test methods, providing daily quality control (QC) support. Responsibilities include implementing automated measurement systems, establishing process monitoring, and leading investigations to reduce scrap, while ensuring adherence to change control requirements. Additional responsibilities include authoring and managing documentation related to test method validation, measurement system analysis, inspection procedures, and risk analysis. 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. Lead the analysis of complaint investigations and ensure compliance with quality management systems and regulatory requirements. Additionally, assisting in conducting internal audits, maintaining up-to-date technical knowledge, and supervising and mentoring production inspectors are important duties.

Essential duties and responsibilities include, but are not limited to, the following:

• Design, configure, implement and maintain automated measurement systems. Includes creation of inspection tooling fixtures.
• Develop and execute test methods validation, measurement system analysis protocols and process validation. Generate complex technical written reports, including statistical analysis to justify sample size selection, equivalence, and acceptable error rates.
• Author and manage documentation related to test methods, inspection training and procedures.
• Deploy process monitoring systems and maintain statistical process control (SPC) practices.
• Support production by troubleshooting issues, improving yields, and collaborating with contract manufacturers to resolve quality issues. Ensure timely closure of non-conforming material reports (NCRs) and adherence to internal procedures.
• Serve as subject matter expert (SME) for inspection methods for devices manufacturing and purchased components.
• Mentor and train inspector technicians to automated inspection systems and inspection good practices aligned with ISO/IEC 17025 principles.
• Review and approve Quality Engineering assessments for Document Change Orders (DCOs) and Supplier Change Notices (SCNs).
• Define and implement quality improvement projects for EBR and supplier’s manufacturing processes. Work with various departments to ensure timely closure of CAPAs, NCRs, and complaints.
• Coordinate cross-functionally to release or place materials on hold when segregated as non-conforming. Document nonconformances, including root cause analysis and corrective actions.
• Support the supplier quality management program through supplier monitoring, audits and issues resolution, including supplier corrective action requests (SCARs), operations NCRs and audit findings.
• 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.
• Other duties as assigned.

Education and Required Experience:

• BS in Mechanical engineer or biomedical engineering.
• Four years of related medical device experience.
• Can be an equivalent combination of education and professional experience.

Knowledge, Skills, and 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 software, such as MiniTab, Solidworks, MasterControl 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.

Physical Requirements:

• 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: $115,600 - $156,400*

*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. Additional compensation may include bonuses and equity, along with a comprehensive benefits package.

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

Equal Opportunity Employer Veterans/Disabled

About the Company

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.

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

• Medical, dental, and vision insurance provided at no cost for employee-only coverage
• 401(k) matching plan
• Paid Time Off – starting at 3 weeks per year
• Competitive salary with opportunities for career growth
• Employee stock options
• Life & AD&D and long term disability insurance
• Education assistance
• Voluntary commuter benefits and pet insurance
• Weekly company lunches and occasional happy hour events
• Meaningful work and much more!

Equal Opportunity Employer Veterans/Disabled