Mechanical Engineer III - Med Device R&D Lead

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

Benefits offered by this job

Competitive compensation

Excellent healthcare: medical, dental,

Short & long term disability and life

401K with company match

Employee Stock Purchase Plan

Tuition assistance

Job summary

CONMED Corporation, based in Denver, CO, seeks a senior mechanical/biomedical engineer to lead EU MDR remediation within the Advanced Surgical R&D portfolio. You will drive design improvements for minimally invasive devices and coordinate cross-functional teams to ensure regulatory compliance and product quality throughout the development lifecycle.

The role emphasizes design controls, SolidWorks CAD work, root-cause investigations, and the mentorship of engineers while shaping best practices

Qualifications

• BS in Mechanical or Biomedical Engineering is required.
• 5 years of product development engineering; 3 years with a master’s degree.
• Experience CAD in SolidWorks or equivalent in regulated settings.
• Understanding of FDA 21 CFR 820 and ISO 13485/14971.
• Experience with cross-functional teams in a regulated environment.
• Strong knowledge of design controls and industry standards.

Responsibilities

• Lead remediation design activities for medical devices per EU MDR and ISO 13485.
• Ensure designs comply with safety, regulatory, and quality requirements.
• Assist with quality management reviews and external audits.
• Develop test protocols, reports, and presentations; perform root-cause analyses.
• Execute CAD modeling, prototyping, and full product development cycle tasks.
• Coordinate project schedules and budgets with cross-functional teams.

Skills

Mechanical Engineering

Biomedical Engineering

3D CAD (SolidWorks)

Regulated environment

Design controls

Cross-functional teamwork

Technical leadership

Education

B.S. in Mechanical Engineering

B.S. in Biomedical Engineering

M.S. in Mechanical/Biomedical Engineering

Tools

SolidWorks

GD&T

Engineering drawings

Job description

CONMED Corporation, based in Denver, CO, seeks a senior mechanical/biomedical engineer to lead EU MDR remediation within the Advanced Surgical R&D portfolio. You will drive design improvements for minimally invasive devices and coordinate cross-functional teams to ensure regulatory compliance and product quality throughout the development lifecycle.

The role emphasizes design controls, SolidWorks CAD work, root-cause investigations, and the mentorship of engineers while shaping best practices