Design Quality Engineer: Medical Device Compliance

CONMED Corporation; Denver (CO); On-site; USD 74,000 - 95,000; Full time

Benefits offered by this job

Competitive compensation

Excellent healthcare including medical

401K with company match

Employee Stock Purchase Plan

Tuition assistance for undergraduate &

Job summary

CONMED Corporation in Colorado is seeking a Design Quality Engineer to support quality engineering activities across the new product lifecycle, from concept to commercialization, and sustaining activities. You will ensure compliance with ISO, FDA QSR, and EU MDR, and lead quality initiatives with cross-functional teams.

You will review design controls, risk management, verification and validation, and support audits and process improvements while focusing on patient safety and device efficacy.

Qualifications

• BS in Engineering with 2+ years medical device experience (MS with 1+ year acceptable).
• Experience interpreting/applying Quality Systems Regulations and ISO standards OR design controls (21 CFR 820, ISO 13485, ISO 14971, EU MDR).

Responsibilities

• Support and provide direction to product development teams for quality deliverables.
• Ensure product designs meet regulatory requirements and customer expectations; pursue continuous improvement.
• Review and approve design documentation and changes for quality, reliability, and manufacturability.
• Lead risk management activities prioritizing clinician and patient safety.
• Support verification/validation activities and design reports to address inputs and needs.
• Assist in quality investigations, trend analysis, and CAPA activities; participate in audits.

Skills

Quality engineering

Regulatory compliance

Risk management

Analytical skills

Education

Bachelor's degree in Engineering (Electrical, Mechanical, or Biomedical)

Master's degree in Engineering

Job description

CONMED Corporation in Colorado is seeking a Design Quality Engineer to support quality engineering activities across the new product lifecycle, from concept to commercialization, and sustaining activities. You will ensure compliance with ISO, FDA QSR, and EU MDR, and lead quality initiatives with cross-functional teams.

You will review design controls, risk management, verification and validation, and support audits and process improvements while focusing on patient safety and device efficacy.