Quality Engineer

Role Summary:

The Quality Engineer supports Capstan Medical's mitral and/or tricuspid structural heart valve product line from development through manufacturing readiness and production. This role partners with R&D, Operations/Manufacturing, Regulatory Affairs, and Quality to ensure design controls, risk management, sterilization, microbiology test methods, acceptance activities, and release processes meet company and regulatory expectations.

Core Responsibilities

• Serve as the Quality Engineering representative for assigned structural heart valve products, supporting design controls, risk management, design verification/validation, design transfer, DHF/DMR content, and product/process changes.

• Apply knowledge of structural heart implant expectations, including the ISO 5840 series, to support product requirements, verification/validation strategies, and objective evidence.

• Support liquid chemical sterilization activities for products that may contain animal-derived tissue, including validation, routine monitoring, deviations, requalification, and release support; maintain working knowledge of ISO 14160, ISO 22442, ISO 11135, and other relevant sterilization standards.

• Support sterilization-related microbiology test methods and data review, including bioburden, sterility, bacterial endotoxin/BET-LAL, microbial identification, method suitability, excursions, and trending; provide trained backup support to the in-house microbiologist for defined routine activities as needed.

• Assist Operations and Manufacturing Engineering in establishing acceptance activities, including incoming, in-process, and final inspection/test requirements, sampling plans, acceptance criteria, inspection methods, test method validation needs, fixtures, and quality records.

• Support cleanroom and controlled manufacturing operations, including issue triage, process validation/qualification review, line readiness, DHR review, finished goods release, and lot/batch disposition.

• Lead or support NCR, MRB, CAPA, audit, and continuous improvement activities, including root cause analysis, risk-based disposition, effectiveness verification, and quality data trending.

• Create, review, and improve SOPs, work instructions, forms, templates, and quality records related to product quality, sterilization, microbiology testing, acceptance activities, DHR review, and manufacturing quality processes.

Skills

• Strong understanding of medical device quality systems, design controls, risk management, production/process controls, acceptance activities, change control, NCR, MRB, and CAPA.

• Working knowledge of structural heart valve/cardiovascular implant standards and expectations; ISO 5840 experience preferred.

• Experience with sterile medical device processes, with strong preference for liquid chemical sterilization and animal tissue-containing products.

• Working knowledge of microbiology and sterility assurance test methods, including bioburden, sterility, endotoxin/BET-LAL, microbial identification, and related test method controls.

• Ability to translate design, manufacturing, sterilization, and risk requirements into practical inspection/test methods, acceptance criteria, and release requirements.

• Strong problem-solving, technical judgment, data analysis, documentation, and risk-based decision-making skills.

• Effective cross-functional communication with R&D, Operations, Manufacturing Engineering, Regulatory Affairs, technicians, auditors, suppliers, labs, and sterilization partners.

Requirements

• Bachelor's degree in Engineering, Life Sciences, Microbiology, or a related technical field; advanced degree or CQE/CQA/ASQ certification is a plus.

• 5+ years of quality engineering experience in medical devices; experience with Class III, implantable, cardiovascular, structural heart, tissue-based, or sterile devices is strongly preferred.

• Experience supporting design controls, risk management, design transfer, verification/validation, DHF/DMR documentation, and product/process changes.

• Experience establishing manufacturing acceptance activities, inspection/test methods, sampling plans, acceptance criteria, and quality records in a regulated production environment.

• Experience supporting sterilization validation, routine control, microbiology testing, and product release for sterile medical devices; liquid chemical sterilization experience is strongly preferred.

• Familiarity with relevant regulations and standards, including FDA 21 CFR Part 820/QMSR, ISO 13485, ISO 14971, ISO 5840, ISO 14160, ISO 22442, ISO 11135, and applicable sterilization, packaging, biocompatibility, and microbiology test standards.

• Experience working in cleanroom or controlled manufacturing environments; ability to work onsite and cross-functionally with R&D and Operations teams as needed.

Why join us:

• We offer a fun, fast-paced, collaborative environment where you will be working on transformational technologies in the cardiac healthcare space that can make a meaningful impact for patients

• 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.