Design Quality Engineer – Medical Devices & Compliance

CONMED; Greenwood Village (CO); On-site; USD 74,000 - 95,000; Full time

Job summary

CONMED is seeking a Design Quality Engineer to support quality activities across the medical device lifecycle, from concept to commercialization and sustaining. You will be the quality engineering contact on cross‑functional teams to ensure compliance with QSR, ISO 13485, EU MDR, and related standards.

The role emphasizes risk management, design verification and validation, and CAPA leadership, with collaboration across manufacturing and suppliers to ensure product safety, reliability, and

Qualifications

• B.S. in Electrical, Mechanical or Biomedical Engineering with 2+ years medical device experience (or M.S. with 1+ year).
• 1 year experience interpreting and applying Quality Systems Regulations and ISO quality requirements OR 1 year in design controls, 21 CFR 820, ISO 13485, ISO 14971, EU MDR, and applicable medical device regulations.
• Professional certifications (CQE, CQA, CMQ/OE, Lead Auditor) desirable.
• Design for Six Sigma training and knowledge of statistical methodologies.

Responsibilities

• Supports and provides direction to product development teams for the required quality deliverables.
• Review, assess, and approve product design documentation for compliance throughout product development cycle.
• Review and approve engineering designs/changes for quality, reliability, maintainability, risk management, modeling, systems design, assessment tools, reporting, and manufacturability.
• Lead risk management activities with a focus on clinician and patient safety.
• Support sustaining activities such as complaint investigation and complaint trending.
• Monitor and analyze manufacturing and service trends; perform predicate device reviews and surveillance reports.
• Travel requirements (including international): 0-5%.
• Support internal and external audits and audit preparation activities.

Skills

Communication

Problem solving

Organizational skills

Interpersonal skills

Technical writing

Planning & project management

Independent work

Decision intelligence

Education

B.S. in Electrical/Mechanical/Biomedical Engineering

M.S. in Engineering

Job description

CONMED is seeking a Design Quality Engineer to support quality activities across the medical device lifecycle, from concept to commercialization and sustaining. You will be the quality engineering contact on cross‑functional teams to ensure compliance with QSR, ISO 13485, EU MDR, and related standards.

The role emphasizes risk management, design verification and validation, and CAPA leadership, with collaboration across manufacturing and suppliers to ensure product safety, reliability, and