Medical Device Design Quality Engineer

CONMED Corporation; Denver (CO); On-site; USD 74,000 - 92,000; Full time

Benefits offered by this job

Competitive compensation

Excellent healthcare coverage

Disability and life insurance

401K with company match

Employee Stock Purchase Plan

Tuition assistance

Job summary

CONMED Corporation is seeking a Design Quality Engineer to support the full product lifecycle from concept through commercialization and sustaining activities. The role ensures compliance with ISO, EU MDR, and FDA QSR requirements for medical devices and leads quality initiatives with cross-functional teams.

You will review designs, support risk management, and drive investigations and corrective actions while advocating patient safety and product reliability.

Qualifications

• Requires B.S. in Engineering and 2+ years medical device experience (M.S. with 1+ years acceptable).
• Familiar with Quality Systems Regulations, ISO 13485, ISO 14971, EU MDR, and FDA QSR.

Responsibilities

• Support product development teams with required quality deliverables and ensure design meets requirements.
• Review and approve design documentation, verification and validation protocols and reports for quality and compliance.
• Lead risk management activities focusing on clinician and patient safety.
• Investigate quality issues, drive corrective actions, and lead data-driven problem solving across functions.
• Support internal/external audits and supplier quality activities.

Skills

Quality engineering

Regulatory knowledge

Cross-functional teamwork

Risk management

Problem solving

Communication

Education

B.S. in Engineering (Electrical/Mechanical/Biomedical) + 2+ yrs medical device exp

Job description

CONMED Corporation is seeking a Design Quality Engineer to support the full product lifecycle from concept through commercialization and sustaining activities. The role ensures compliance with ISO, EU MDR, and FDA QSR requirements for medical devices and leads quality initiatives with cross-functional teams.

You will review designs, support risk management, and drive investigations and corrective actions while advocating patient safety and product reliability.