Mechanical Engineer II

CONMED•Greenwood Village, CO
•$70,000 - $109,000•Hybrid

About The Position

CONMED is seeking a Mechanical Engineer II for the Advanced Surgical division’s R&D team in the Denver, Colorado area. This engineer will contribute to the active product portfolio, focusing on minimally invasive surgical technologies, and will serve as a mechanical engineering technical lead for EU MDR remediation across the Advanced Surgical portfolio. The role follows a hybrid work schedule. Candidates outside the Denver area may apply, and relocation assistance is available to qualified candidates who need to relocate to the Denver metro area. Advanced Surgical products include advanced insufflation systems, advanced energy systems, advanced smoke management systems, and laparoscopic surgical instruments. The position involves leading remediation and product development work, ensuring regulatory and quality compliance, conducting design and verification activities, investigating product issues, and collaborating with cross-functional teams, customers, and other stakeholders. The role is suited to a driven team player who can contribute to multiple projects in a fast-paced, cross-functional environment. The annual salary range is $70,000–$109,000; actual compensation may vary based on location, experience, education, and skills. The posting is anticipated to close November 9, 2026, but may be extended. This position is not eligible for employer-based sponsorship.

Requirements

  • 3–5+ years of engineering work experience.
  • Bachelor of Science in Mechanical Engineering or a highly related field.
  • Intermediate skill 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-sized 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-sized 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.
  • Independently develop test protocols, reports, and presentations, demonstrating a comprehensive understanding of the design process.
  • Investigate product issues to identify root causes and implement corrective and preventive actions.
  • Perform conceptual and detailed design, CAD modeling, prototyping, and troubleshooting across 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 to support engineers with common and complex 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 (401(k)) with dollar-for-dollar matching, with potential matching up to 7% per pay period.
  • Employee Stock Purchase Plan with discounted stock purchases.
  • Tuition assistance for undergraduate and graduate-level courses.
  • Employee Referral Program incentives.
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