Mechanical Engineer II

CONMED Corporation • Denver, CO

5d • $70,000 - $109,000 • Hybrid

About The Position

CONMED is seeking a Mechanical Engineer II to join the Advanced Surgical division’s R&D team in the Denver, Colorado area. The role contributes to the development and remediation of products across the active portfolio, including minimally invasive surgical technologies. The engineer will serve as a mechanical engineering technical lead for EU MDR remediation across the Advanced Surgical portfolio.

The position works with advanced insufflation systems, advanced energy systems, advanced smoke management systems, and laparoscopic surgical instruments. It involves design and development activities across the product lifecycle, regulatory and quality compliance, verification and validation, investigations, and cross-functional project leadership. The position follows a hybrid work schedule. Candidates outside the Denver area may apply; relocation assistance is available to qualified candidates who need to relocate to the Denver metro area.

The position is not eligible for employer-based sponsorship. The disclosed annual salary range is $70,000–$109,000; actual compensation may vary based on geographic location, work experience, education, and skill level.

Requirements

• 3–5+ years of engineering work experience.
• B.S. in Mechanical Engineering or a highly related field.
• Intermediate skills in 3-D CAD software such as SolidWorks or equivalent.
• Experience working in a regulated environment, such as FDA 21 CFR 820 or similar.
• Strong understanding of design controls (21 CFR 820.30), ISO 13485, ISO 14971, and IEC/ISO standards related to the product type.
• Experience working with small or medium cross-functional teams.

Nice To Haves

• Intermediate technical writing skills.
• Experience overseeing engineers as a technical lead.
• Basic knowledge of GD&T and creating engineering drawings.
• Intermediate knowledge of design for manufacturing, including machining, injection molding, and assembly.
• Intermediate knowledge of statistics.
• Intermediate knowledge of project management principles and budgeting.
• Strong knowledge of root cause investigations and problem solving.
• Intermediate skills in 3-D CAD software such as SolidWorks or equivalent.
• Experience working in a regulated environment, such as FDA 21 CFR 820 or similar.
• Strong understanding of design controls (21 CFR 820.30), ISO 13485, ISO 14971, and IEC/ISO standards related to the product type.
• Experience working with small or medium cross-functional teams.

Responsibilities

• Lead and support medical-device remediation design activities in accordance with EU MDR and ISO 13485.
• Ensure designs comply with applicable industry standards, safety regulations, and quality control procedures.
• Assist with quality management system reviews and participate in external audits to support compliance and continuous improvement.
• Develop test protocols, reports, and presentations independently, using a comprehensive understanding of the design process.
• Investigate product issues, identify root causes, and implement corrective and preventive actions.
• Perform conceptual and detailed design, CAD modeling, prototyping, and troubleshooting throughout the product development cycle.
• Conduct design analyses, including theoretical calculations for component fit, tolerance analysis, and stress calculations.
• Conduct verification and validation testing.
• Engage with customers to understand their needs and define project requirements.
• Develop project schedules and budgets with project teams.
• Lead cross-functional projects.
• Communicate technical concepts and design solutions to stakeholders, including senior management and customers.
• Contribute to procedural updates and best practices, and create job aids for engineering tasks.

Benefits

• Competitive compensation.
• Medical, dental, vision, and prescription healthcare coverage.
• Short- and long-term disability insurance and life insurance, fully paid by CONMED.
• Retirement Savings Plan (401K), with dollar-for-dollar matching and the potential for up to 7% per pay period.
• Employee Stock Purchase Plan with discounted stock purchases.
• Tuition assistance for undergraduate and graduate courses.
• Employee Referral Program incentives.
• Relocation assistance for qualified candidates selected for the role who require relocation to the Denver metro area.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level