The posting
Purpose
The Senior Design Quality Engineer serves as the quality representative and subject matter expert for new product development and lifecycle management activities. This role provides leadership in the application of Design Controls, Risk Management, Verification & Validation, usability engineering, transfer to manufacturing, and regulatory compliance activities for medical devices. The Senior Design Quality Engineer independently leads complex quality engineering projects, provides strategic guidance to cross-functional teams, mentors junior engineers, and partners with Regulatory Affairs, R&D, Clinical, Manufacturing, Supply Chain, and Operations to ensure products are developed and maintained in accordance with applicable global regulations and quality system requirements.
**This is an on-site role in Memphis, TN.**
Key Duties and Responsibilities
- Serve as Design Quality lead for product development projects.
- Provide quality oversight throughout the design control process.
- Lead risk management activities in accordance with ISO 14971.
- Review and approve DHF documentation.
- Support design reviews and ensure compliance with FDA, ISO 13485, EU MDR, and other applicable regulations.
- Provide quality leadership for verification and validation activities.
- Support design transfer and manufacturing readiness activities.
- Act as quality SME for product development teams.
- Lead investigation of complex product complaints, field issues, and quality events related to commercialized products.
- Support complaint trending, post-market surveillance, and product performance monitoring.
- Lead or support NCs/CAPAs associated with released products.
- Evaluate and implement design changes, supplier changes, manufacturing changes, and risk management updates impacting released products.
- Partner with Operations, Regulatory Affairs, and Supply Chain to resolve product quality issues.
- Support assessment of field actions, recalls, and regulatory reporting activities as applicable.
- Participate in lifecycle risk assessments and product improvement initiatives. Internal quality procedures
- Support global regulatory submissions and associated quality documentation.
- Participate in internal, supplier, customer, and regulatory audits.
- Support inspection readiness activities.
- Ensure quality records comply with regulatory and internal requirements.
- Drive continuous improvement initiatives within the Quality Management System.
- Mentor and provide technical guidance to Quality Engineers and cross-functional partners.
- Lead complex quality engineering projects with minimal supervision.
- Develop and improve quality engineering procedures, templates, and best practices.
- Serve as a technical escalation point for quality and compliance issues.
- Influence strategic quality decisions through risk-based decision making.
MINIMUM REQUIREMENTS
- B.S. degree in Engineering such as Electrical, Mechanical, or Biomedical Engineering and 5+ years of medical device experience (or equivalent work experience).
- 2 years of experience supporting Design Controls, Risk Management, Verification & Validation, and product lifecycle management.
- 2 years of experience supporting both new product development and sustaining/commercialized product activities.
PREFERRED REQUIREMENTS
- Experience supporting FDA inspections and notified body audits.
- Experience with 510(k), PMA, EU MDR, or international regulatory submissions.
- Experience leading cross-functional quality initiatives and mentoring engineers.
- Experience utilizing data analysis and visualization tools.
- Familiarity with Lean, Six Sigma, or continuous improvement principles.
- Technical writing experience.
- Knowledge of quality engineering tools such as:
- Fishbone Diagrams
- 5 Whys
- Strong analytical and problem-solving skills.
- Effective verbal and written communication skills.
- Ability to work collaboratively in cross-functional environments.
- Strong organizational skills and attention to detail.
- Ability to manage multiple priorities in a fast-paced environment.
- Proficient with Microsoft Office applications including Excel, Word, and PowerPoint.
- Pareto Analysis
- FMEA concepts
- Statistical trend analysis
ADA Disclosure:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Benefits:
CONMED offers a wide array of benefits to fit your unique needs. Visit our Benefits Page for more information.
- Competitive compensation
- Excellent healthcare including medical, dental, vision and prescription coverage
- Short & long term disability plus life insurance -- cost paid fully by CONMED
- Retirement Savings Plan (401K) -- CONMED matches your contributions dollar for dollar, with the potential for up to 7% per pay period
- Employee Stock Purchase Plan -- allows stock purchases at discounted price
- Tuition assistance for undergraduate and graduate level courses
Know someone at CONMED? Have them submit you as a referral before applying for this position to be eligible for our Employee Referral Program incentives!
CONMED is an equal opportunity employer and does not discriminate on the basis of any legally protected status or characteristic. Protected veterans and individuals with disabilities are encouraged to apply. The Know Your Rights: Workplace Discrimination is Illegal Poster reaffirms this commitment.
Colorado Residents: In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.
If you feel you need a reasonable accommodation pursuant to the ADA, you are encouraged to contact us at 800-929-7176 option #5.
