Medical Device Quality Engineer

Who We Are
ABOUT ENOVIS™
Enovis Corporation (NYSE: ENOV) is an innovation-driven medical technology growth company dedicated to developing clinically differentiated solutions that generate measurably better patient outcomes and transform workflows. Powered by a culture of continuous improvement, global talent and innovation, the Company’s extensive range of products, services and integrated technologies fuels active lifestyles in orthopedics and beyond. For more information about Enovis, please visit www.enovis.com.
What You'll Do
At Enovis™ we pay attention to the details. We embrace collaboration with our partners and patients, and take pride in the pursuit of scientific excellence — with the goal of transforming medical technology as we know it.
Because that’s how we change the lives of patients for the better. And that’s how we create better together. Why work at Enovis? See for yourself.
As a key member of the Quality Team you will play an integral part in helping Enovis drive the medical technology industry forward through transforming patient care and creating better patient outcomes.
Job Title:
Medical Device Quality Engineer
Reports To:
Manager, Quality Engineering
Location:
Austin, Texas
Business Unit Description:
As a key member of the Quality Assurance team, you will play an integral part in helping Enovis drive the medical technology industry forward through transforming patient care and creating better patient outcomes.
Job Title/High-Level Position Summary:
The Medical Device Quality Engineer is an experienced individual contributor responsible for independently leading complex quality engineering activities across orthopedic device manufacturing, product development, supplier quality, and quality systems. The role applies 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.
This position supports precision machining, finishing, inspection, product cleaning, cleanroom operations, and other manufacturing processes. The Quality Engineer also serves as a technical resource and mentor to less-experienced engineers and cross-functional partners.
Key Responsibilities:
Ensure compliance with internal and external specifications, procedures, and applicable requirements, including GMP, ISO 13485, ISO 14971, and FDA.
Lead the evaluation of complex product quality issues that may affect device performance, patient safety, or regulatory compliance.
Lead the 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.
Minimum Basic Qualifications:
Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, Science, or a related technical field and 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.

Skills
Data Analysis, Risk Management, Patient Care, Regulatory Compliance, Documentation

Experience
5+ yrs