Mechanical Engineer II — EU MDR Lead, Hybrid Denver

CONMED Corporation; Denver (CO); Hybrid; USD 70,000 - 109,000; Full time

Benefits offered by this job

Competitive compensation

Excellent healthcare (medical, dental,

401K with match

Tuition assistance

Employee Stock Purchase Plan

Job summary

CONMED is seeking a Mechanical Engineer II in Denver, CO to join its Advanced Surgical R&D team. The role focuses on remediation aligned with EU MDR, ISO 13485, and 21 CFR 820, leading cross-functional engineering activities and ensuring design integrity across the product portfolio.

Based in the Denver area with a hybrid schedule, you will contribute to minimally invasive surgical technologies, perform CAD design, testing, and validation, and interact with customers to define project

Qualifications

• 3-5+ years of engineering experience in medical devices or related field.
• Experience with regulated environments (FDA 21 CFR 820) and ISO 13485 is required.
• Strong knowledge of design controls (21 CFR 820.30) and ISO/IEC standards is essential.
• Ability to lead cross-functional teams and communicate with stakeholders.
• Proficiency in interpreting requirements and documenting design and test activities.

Responsibilities

• Lead remediation design activities for medical devices in line with EU MDR and ISO 13485.
• Ensure designs meet safety regulations and quality control procedures.
• Assist with quality system reviews and external audits for compliance and improvement.
• Develop test protocols, reports, and presentations independently.
• Investigate root causes of product issues and implement corrective actions.
• Perform CAD modeling, prototyping, and design verification across the product lifecycle.
• Conduct design analyses including tolerance stack-ups and stress calculations.
• Lead project scheduling and budgeting with cross-functional teams.
• Communicate complex technical concepts to management and customers.
• Create job aids and update procedures to support other engineers.

Skills

3-5+ years engineering experience

FDA/regulatory exposure

Design controls knowledge

Cross-functional teamwork

Regulatory standards knowledge

Education

B.S. in Mechanical Engineering

Tools

SolidWorks

Job description

CONMED is seeking a Mechanical Engineer II in Denver, CO to join its Advanced Surgical R&D team. The role focuses on remediation aligned with EU MDR, ISO 13485, and 21 CFR 820, leading cross-functional engineering activities and ensuring design integrity across the product portfolio.

Based in the Denver area with a hybrid schedule, you will contribute to minimally invasive surgical technologies, perform CAD design, testing, and validation, and interact with customers to define project