Senior Mechanical Engineer - Med Devices, EU MDR Lead

CONMED Corporation; Denver (CO); On-site; USD 82,000 - 125,000; Full time

Benefits offered by this job

Competitive compensation

Excellent healthcare

401K with company match

Employee Stock Purchase Plan

Tuition assistance

Job summary

CONMED Corporation in Denver, CO, is seeking a mechanical engineer to join its Advanced Surgical R&D team focused on EU MDR remediation across the portfolio of minimally invasive technologies. You will lead design activities, ensure compliance with 21 CFR 820, ISO 13485, and related standards, and mentor others while driving cross‑functional projects from concept to validation.

This role offers a challenging environment with opportunities to influence product development, contribute to quality

Qualifications

• B.S. in Mechanical, Biomedical Engineering, or related field.
• 5 years product development engineering with bachelor's; 3 years with master's.
• CAD software 3-D (SolidWorks) proficiency.
• Experience in regulated environments (FDA 21 CFR 820).
• Knowledge of design controls, ISO 13485, IEC/ISO standards.
• Experience leading cross-functional teams.

Responsibilities

• Lead remediation design activities for medical devices per EU MDR.
• Ensure designs meet standards, safety regulations, quality procedures.
• Support quality management reviews and audits.
• Develop test protocols, reports, and presentations.
• Perform root cause investigations and implement CAPA.
• Contribute to design processes and project leadership.

Skills

Mechanical engineering

Regulated environment

Cross-functional teamwork

Root cause analysis

Education

B.S. in Mechanical or Biomedical Engineering

Tools

SolidWorks

GD&T

Engineering drawings

Job description

CONMED Corporation in Denver, CO, is seeking a mechanical engineer to join its Advanced Surgical R&D team focused on EU MDR remediation across the portfolio of minimally invasive technologies. You will lead design activities, ensure compliance with 21 CFR 820, ISO 13485, and related standards, and mentor others while driving cross‑functional projects from concept to validation.

This role offers a challenging environment with opportunities to influence product development, contribute to quality