Senior Design Quality Engineer – Medical Devices

CONMED Corporation; Memphis (TN); On-site; USD 110,000 - 160,000; Full time

Benefits offered by this job

Competitive compensation

Excellent healthcare including medical

401K matching

Employee Stock Purchase Plan

Tuition assistance

Referral program incentives

Job summary

CONMED Corporation in Memphis, TN, seeks a Senior Design Quality Engineer to lead design controls and risk management for medical devices. You will mentor teams, drive V&V, and ensure regulatory compliance across FDA/ISO requirements, with on-site collaboration across R&D, Regulatory Affairs, and Operations.

You will provide expert quality leadership for product development, investigate field issues, and guide NCAs/CAPAs while supporting manufacturing transfer and post-market surveillance in a

Qualifications

• B.S. degree in Engineering and 5+ years medical device 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.

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.

Skills

Design Controls

Risk Management

Verification & Validation

Regulatory Knowledge

Leadership

Mentoring

Cross-functional Collaboration

Education

B.S. in Engineering

Tools

FMEA

Fishbone Diagram

Pareto Analysis

Statistical Trend Analysis

MS Office

Job description

CONMED Corporation in Memphis, TN, seeks a Senior Design Quality Engineer to lead design controls and risk management for medical devices. You will mentor teams, drive V&V, and ensure regulatory compliance across FDA/ISO requirements, with on-site collaboration across R&D, Regulatory Affairs, and Operations.

You will provide expert quality leadership for product development, investigate field issues, and guide NCAs/CAPAs while supporting manufacturing transfer and post-market surveillance in a