Product Quality Engineer - Robot

Capstan Medical; Santa Cruz (CA); On-site; USD 110,000 - 150,000; Full time

Benefits offered by this job

Health, dental, vision coverage

Flex time off

Team outings / recreational activities

Job summary

Capstan Medical, based in Santa Cruz, CA, seeks a Product Quality Engineer to support the manufacturing line for robotic medical devices. You will oversee quality during production, ensure GMP/ISO compliance, and drive CAPAs and NCR investigations with cross-functional teams.

This role requires a bachelor’s in engineering, 5+ years in medical device QA manufacturing, and hands-on experience with FDA regulations and ISO 13485.

Qualifications

• Bachelor’s degree in Engineering or related field required.
• Minimum 5 years in manufacturing quality engineering in medical devices.
• Deep knowledge of FDA regulations, ISO 13485, IEC 60601‑1.
• Experience with nonconforming material investigations and CAPAs.
• Ability to work in a fast-paced environment.

Responsibilities

• Oversee product quality during all production stages and field service.
• Ensure GMP/quality systems compliance throughout manufacturing.
• Lead NCR investigations, root-cause analysis, and CAPAs.
• Conduct MRB reviews and material decisions.
• Support field service, rework, and device history records.
• Develop validation protocols and perform IQ/OQ/PQ activities.
• Collaborate cross-functionally to resolve quality issues.
• Perform audits and apply Lean and Six Sigma for improvement.
• Prepare documentation for regulatory compliance and audits.

Skills

Quality engineering

FDA regulations

CAPA investigations

Lean Six Sigma

Document control

Cross-functional collaboration

Education

Bachelor's degree in Engineering

Master's degree preferred

Job description

At Capstan Medical, we’re building one of the most exciting and innovative companies in medtech—developing a first‑of‑its‑kind robotic platform for minimally invasive heart valve treatment. Our team combines surgical robotics, catheter‑based delivery, and next‑generation implants to transform complex procedures into safer, lower‑stress solutions for patients and clinicians alike. As a highly collaborative, hands‑on team, we move fast, wear multiple hats, and believe the best ideas can come from anyone.

Based in Santa Cruz, our unique workspace blends cutting‑edge Bay Area innovation with a lifestyle‑driven environment near trails, beaches, and open space—creating the perfect place to do meaningful, career‑defining work.

Reports to: Quality Manager

Workplace type: Onsite in Santa Cruz, CA

The Opportunity

The Product Quality Engineer is responsible for providing quality engineering support to the manufacturing line, supporting testing activities, and supporting packaging validation and finished goods release for robotic devices.

What you’ll do

Manufacturing responsibilities include:

• Oversee product quality during all stages of production and field service.
• Ensure compliance with Good Manufacturing Practices (GMP) regulations and internal quality management systems throughout the manufacturing process.
• Lead and support investigations into nonconforming materials and products (NCRs), working closely with cross‑functional teams including Manufacturing and Engineering, identifying root causes, ensuring timely resolution, and implementing effective corrective and preventive actions (CAPAs) to prevent recurrence.
• Conduct Material Review Board and participate in materials decision making.
• Establish, implement, and support processes for field service and rework of robotic medical devices.
• Maintain Device History Records for robotic medical devices.
• Support creation of risk management files, including the development of Process FMEA.
• Lead and support process validation activities, including IQ/OQ/PQ (Installation Qualification/Operational Qualification/Performance Qualification), for new and existing manufacturing processes.
• Develop validation protocols, execute validation activities, and compile validation reports to ensure process robustness and consistency.
• Collaborate with cross‑functional teams, including Manufacturing and Engineering, to resolve quality issues and identify opportunities for process improvement and efficiency gains within the manufacturing environment.
• Perform audits of manufacturing processes, including inspections, testing, and documentation, to identify areas for improvement and ensure adherence to quality standards.
• Implement Lean and Six Sigma principles to drive continuous improvement initiatives.

Testing responsibilities include:

• Collaborate with cross‑functional teams to ensure that design, manufacturing, and standards‑based test requirements are met.
• Provide guidance on processes and validations to ensure product safety and compliance.

Packaging and Finished Goods Release responsibilities include:

• Oversee packaging validation activities to ensure product integrity and stability during storage and transportation.
• Participate in finished goods release processes, ensuring compliance with release criteria and applicable regulatory requirements.

Documentation and Compliance responsibilities include:

• Maintain accurate and up‑to‑date documentation related to quality control processes, inspection results, metrology records, nonconformance reports, and corrective actions.
• Ensure compliance with relevant regulatory requirements, such as FDA QSR and ISO 13485 standards.
• Support internal and external audits, including preparation of documentation, participation in audits, and implementation of audit findings.

What you’ll need

• Bachelor’s degree in Engineering or a related technical field. Master’s degree is a plus.
• Minimum of 5 years of experience in a manufacturing quality engineering role within the medical device industry supporting electromechanical capital devices.
• In‑depth knowledge of FDA regulations, ISO 13485, IEC 60601‑1, and other relevant quality & safety standards for robotic medical devices.
• Experience with nonconforming material investigations and implementing effective CAPAs.
• Ability to work in a fast‑paced environment.

Ways to stand out from the crowd

• Experience supporting development and manufacturing of surgical robotic devices.
• Certifications such as Six Sigma and ASQ Certified Quality Engineer (CQE) or Certified Quality Auditor (CQA).
• Familiarity with process validation (IQ/OQ/PQ), electrical safety testing, and packaging requirements for medical devices.
• Strong understanding of GMP regulations and quality management systems.
• Excellent problem‑solving skills and ability to apply root cause analysis methodologies.
• Detail‑oriented with effective organizational and documentation skills.
• Strong communication and collaboration skills to work cross‑functionally and interact with technicians, engineers, auditors, and third parties.
• Attention to detail, with a focus on accuracy and precision in quality‑related activities.

Why join us

• We offer a fun, fast‑paced, collaborative environment where you will be working on transformational technologies in the cardiac healthcare space.
• We offer outstanding benefits with medical, dental, and vision covered at 100% for you and your family, as well as flex time off.
• We thrive in our work‑hard, play‑hard environment. Bring your bike or running shoes if you’d like or just be ready to enjoy a fun office outing. We enjoy time inside the office and out!

We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, national origin, sex, sexual orientation, gender identity, veteran status, and disability, or other legally protected status.

We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.