Medical Device Quality Engineer

Enovis•Austin, TX

1d•Onsite

About The Position

The Medical Device Quality Engineer is an experienced individual contributor who independently leads complex quality engineering activities across orthopedic device manufacturing, product development, supplier quality, and quality systems. The role uses advanced engineering judgment, structured problem-solving, risk management, and data analysis to resolve product and process issues, improve quality performance, and maintain compliance with applicable standards and regulatory requirements. The position supports precision machining, finishing, inspection, product cleaning, cleanroom operations, and other manufacturing processes. It also serves as a technical resource and mentor to less-experienced engineers and cross-functional partners.

Requirements

Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, Science, or a related technical field and a minimum of 5 years of relevant quality, engineering, or regulated manufacturing experience, or an equivalent combination of education and relevant experience.
Experience in the medical-device, pharmaceutical, aerospace, automotive, or another regulated industry.
Demonstrated experience leading nonconformance investigations, root cause analysis, CAPA, risk management, and cross-functional problem-solving.
Experience with process and equipment validation, including IQ/OQ/PQ documentation.
Working knowledge of ISO 13485, ISO 14971, FDA Quality System requirements, GMP, and good documentation practices.
Experience applying quality and problem-solving tools such as DMAIC, 8D, FMEA, statistical analysis, and risk-based decision-making.
Knowledge of manufacturing processes such as precision machining, finishing, inspection/metrology, product cleaning, cleanroom operations, and sterilization.
Ability to interpret engineering drawings, specifications, and Geometric Dimensioning and Tolerancing (GD&T).
Demonstrated ability to write clear, concise, and technically sound documentation.
Proficiency with Microsoft Excel, Word, and PowerPoint.
Ability to work independently, manage competing priorities, and exercise sound engineering judgment on complex issues.
Strong written and verbal communication skills, including the ability to explain technical and compliance topics to varied audiences.
Ability to lead cross-functional teams without direct authority and drive actions to timely closure.
Professional ethics, attention to detail, and commitment to patient safety and product quality.
Ability to coach and mentor less-experienced team members.
Willingness to work in manufacturing, inspection, cleaning, and cleanroom environments as needed.
Ability to lift up to 50 pounds and to bend, twist, and lift overhead, with or without reasonable accommodation.
Applicants must already have full-time work authorization in the United States, both now and in the future, without requiring employment visa sponsorship.

Nice To Haves

Experience supporting orthopedic or implantable medical-device manufacturing.
Experience with supplier quality, supplier audits, SCARs, and supplier performance improvement.
Experience with SolidWorks, SolidWorks ePDM, Oracle R12, Agile PLM, or similar systems.
Certified Quality Engineer (CQE), Lean, Six Sigma, or related certification.

Responsibilities

Ensure compliance with internal and external specifications, procedures, and applicable requirements, including GMP, ISO 13485, ISO 14971, and FDA requirements.
Lead evaluation of complex product quality issues that may affect device performance, patient safety, or regulatory compliance.
Lead evaluation and disposition of complex nonconforming material through the Material Review Board (MRB), including product and patient risk assessment and coordination with cross-functional technical resources.
Lead complex root cause investigations and CAPA activities, including problem definition, root cause analysis, corrective action development, implementation, documentation, and effectiveness verification.
Provide quality engineering support across orthopedic device manufacturing processes, including precision machining, finishing, inspection, product cleaning, and cleanroom operations.
Lead and support process and equipment validation activities, including development and review of validation strategies, protocols, and reports for IQ/OQ/PQ.
Assess product, process, equipment, supplier, and manufacturing changes for potential quality, validation, and regulatory impact.
Lead and support supplier quality activities, including incoming nonconformances, supplier corrective actions (SCARs), supplier audits, supplier changes, and supplier performance improvement.
Facilitate design and manufacturing reviews to ensure compliance with quality system requirements and appropriate application of design controls.
Develop, review, and approve risk-management documentation, including DFMEAs, PFMEAs, and other risk analyses, in alignment with ISO 14971 and applicable procedures.
Review and approve verification and validation plans, protocols, reports, and design outputs for accuracy, completeness, and compliance.
Analyze and trend manufacturing, supplier, complaint, and quality-system data to identify emerging risks, systemic issues, and continuous-improvement opportunities.
Serve as a subject matter expert during internal and external audits, including audit preparation, direct auditor interaction, response development, and closure of findings.
Develop, review, and maintain quality procedures, work instructions, technical documentation, and controlled records.
Partner with Manufacturing, Operations, Product Development, Regulatory, Supplier Quality, and other functions to resolve complex quality and compliance issues.
Lead or support continuous-improvement initiatives using statistical methods, Lean, Six Sigma, and structured problem-solving tools.
Provide technical guidance and mentoring to less-experienced Quality Engineers and cross-functional team members on investigations, risk management, validation, and quality-system requirements.
Support special projects and other quality engineering responsibilities as assigned.