Mechanical Engineer III - Advanced Surgical

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

Growth is our focus at CONMED, and we know that innovation is key to growth and our success! We are dedicated to innovation across our product portfolio and believe in the power of engaged talent on our teams. If you have a growth-mindset, have innovation top-of-mind, and want to be a part of a high performing team,

This position is for a critical member of our Advanced Surgical division’s R&D team, based in Denver, CO. The engineer will have immediate opportunities to contribute to CONMED’s active product portfolio with a focus on minimally invasive surgical technologies designed to deliver real benefits to surgeons, hospitals, and their patients. This position will be dedicated to leading and overseeing EUMDR remediation as a mechanical engineering technical lead across Advanced Surgical’s portfolio.

Advanced Surgical products include:

• Advanced insufflation systems
• Advanced energy systems
• Advanced smoke management systems
• Laparoscopic surgical instruments

Responsibilities:

• Lead and support remediation design activities for medical devices in accordance with EU MDR and ISO 13485.
• Guarantee that all designs comply with relevant industry standards, safety regulations, and quality control procedures.
• Assist with quality management system reviews and participate in external audits to ensure compliance and continuous improvement.
• Possess a comprehensive understanding of the design process and demonstrates the ability to independently develop test protocols, reports, and presentations.
• Conduct thorough investigations to identify root causes of product issues and implement corrective and preventative actions.
• Execute conceptual and detailed designs, CAD modeling, prototyping, and troubleshooting with a comprehensive understanding of the entire product development cycle.
• Conduct design analyses including theoretical calculations for component fit and tolerance analysis and stress calculations.
• Conduct verification and validation testing.
• Engage with customers to gain a deep understanding of their needs and meticulously define project requirements, ensuring precision and alignment with their expectations.
• Develop a project schedule and budget in collaboration with the project teams to ensure alignment and successful execution.
• Lead high-performance, 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 assist other engineers in completing a wide range of job functions, from common to complex tasks.

This role requires a talented and driven team player who is eager to contribute to multiple exciting projects and initiatives.

Required Qualifications:

• B.S. in Mechanical, Biomedical Engineering, or highly related field required
• 5 years related experience in product development engineering with a bachelor’s degree; 3 years with a master’s degree
• 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/medium cross-functional teams

Preferred Qualifications:

• Intermediate technical writing skills
• Experience overseeing engineers as a technical lead
• Basic knowledge with using GD&T and creating engineering drawings
• Intermediate knowledge of designing for manufacturing, such as machining, injection molding, and assembly
• Intermediate knowledge of statistics
• Intermediate knowledge of project management principles and budgeting
• Strong knowledge in root cause investigations and problem solving

This position is not eligible for employer based sponsorship.

Disclosure as required by applicablelaw, the annual salary range for this position is $82,000- $125,000. The actual compensation may vary based on geographic location, work experience, education and skill level. The salary range is CONMED’s good faith belief at the time of this posting.

Coloradoresidents: In any materials you submit, you may redact or remove age identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

This job posting is anticipated to close on September 1, 2026. We may, however, extend this time period, in which case the posting will remain available on careers.conmed.com.

Benefits:

CONMED offers a wide array of benefits to fit your unique needs. Visit our Benefits Page for more information.

• Competitive compensation
• Excellent healthcare including medical, dental, vision and prescription coverage
• Short & long term disability plus life insurance – cost paid fully by CONMED
• Retirement Savings Plan (401K) – CONMED matches your contributions dollar for dollar, with the potential for up to 7% per pay period
• Employee Stock Purchase Plan – allows stock purchases at discounted price
• Tuition assistance for undergraduate and graduate level courses

CONMED is an equal opportunity employer and does not discriminate on the basis of any legally protected status or characteristic. Protected veterans and individuals with disabilities are encouraged to apply. The Know Your Rights: Workplace Discrimination is Illegal Poster reaffirms this commitment.

Colorado Residents: In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

If you feel you need a reasonable accommodation pursuant to the ADA, you are encouraged to contact us at 800-929-7176 option #5.