#R0026720
Engineer to join our medical device manufacturing team. This role drives quality assurance activities, ensures process excellence, and maintains compliance with regulatory standards. The ideal candidate will lead continuous improvement initiatives and collaborate cross-functionally to guarantee product integrity and customer satisfaction.
Key Responsibilities:
Drive root cause analysis and corrective/preventive actions (CAPA) for process and product issues
Develop and monitor process controls (SPC), capability studies, and validation protocols (IQ/OQ/PQ)
Support nonconformance investigations, MRB decisions, and material disposition
Interface with design, manufacturing, and regulatory teams on new product introductions and process changes
Conduct internal audits and prepare for regulatory inspections (FDA, ISO, MDSAP)
Author and revise quality system documents, procedures, and work instructions
Mentor junior engineers and technicians; promote quality culture on the production floor
Collaborate with suppliers to ensure incoming product quality and compliance
Lead Lean, Six Sigma, and Kaizen initiatives to improve yield and reduce defects
Qualifications:
Bachelor's degree in engineering or related field (Mechanical, Biomedical, Industrial preferred)
5+ years of experience in medical device manufacturing quality
Strong knowledge of FDA QSR, ISO 13485, MDSAP, and EU MDR
Hands-on experience with product safety marking approvals (e.g., UL, CE), registration maintenance, and global regulatory submissions
Exposure to FDA inspections, regulatory audits, and product registration processes
Proficient in quality risk management, process validation (IQ/OQ/PQ), and statistical tools (e.g., Minitab)
Excellent analytical, communication, and documentation skills
Bilingual (Spanish/English) a plus
"Creating better together". It's Enovis' purpose, and it's what drives us and empowers us every day on a global scale. We know that the power to create better - for our customers, our team members, and our shareholders - begins with having the best team, pursuing common goals, operating at the highest levels, and delivering extraordinary outcomes.
Watch this short on creating the next generation of better together at Enovis:
We offer a comprehensive benefits package which includes:
Medical Insurance
Dental Insurance
Vision Insurance
Spending and Savings Accounts
401(k) Plan
Vacation, Sick Leave, and Holidays
Income Protection Plans
Legal Services
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. Visit https://www.enovis.com to learn more.
EQUAL EMPLOYMENT OPPORTUNITY:
Enovis provides equal employment opportunities based on merit, experience, and other work-related criteria and without regard to race, color, ethnicity, religion, national origin, sex, age, pregnancy, disability, veteran status, or any other status protected by applicable law. We also strive to provide reasonable accommodation to employees' beliefs and practices that do not conflict with Enovis policies and applicable law. We value the unique contributions that every employee brings to their role with Enovis.
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 https://www.enovis.com.
EOE AA M/F/VET/Disability Statement
All qualified applicants will receive consideration for employment and will not be discriminated against on the basis of race, religion, color, national origin, sex, protected veteran status, disability, or any other basis protected by federal, state or local laws.