Mechanical Engineer III - Advanced Surgical

FHLB Des Moines; Greenwood Village (CO); Hybrid; USD 82,000 - 125,000; Full time

Benefits offered by this job

Competitive compensation

Excellent healthcare coverage

401K with company match

Employee Stock Purchase Plan

Tuition assistance

Job summary

CONMED is seeking a Mechanical Engineer III to lead EU MDR remediation across Advanced Surgical’s portfolio in the Denver area. The role focuses on designing compliant medical devices, leading cross-functional teams, and delivering robust test protocols and analyses.

The position requires a BS in Mechanical or Biomedical Engineering with 5+ years of product development experience, plus familiarity with FDA/ISO standards and CAD tooling.

Qualifications

• BS in Mechanical or Biomedical Engineering; 5+ years product development experience.
• 3+ years of experience if holding a master's degree.
• Experience with regulated environments (FDA 21 CFR 820) and ISO standards.

Responsibilities

• Lead remediation design activities for medical devices per EU MDR and ISO 13485.
• Ensure designs comply with industry standards, safety regulations, and QC procedures.
• Assist with QMS reviews and external audits to ensure compliance and continuous improvement.
• Develop test protocols, reports, and presentations for products.

Skills

3-D CAD (SolidWorks)

Regulated environment

Design controls (21 CFR 820)

Root cause analysis

Education

BS in Mechanical or Biomedical Engineering

Tools

SolidWorks or equivalent

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, consider applying to join CONMED as a Mechanical Engineer III.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.This position is based in Denver, Colorado area and follows a hybrid work schedule.Candidates residing outside of the Denver area are encouraged to apply. Relocation assistance is available for qualified candidates who are selected for the role and require relocation to the Denver metro area.The annual salary range for this position is $82,000- $125,000Advanced Surgical Products Include:Advanced insufflation systemsAdvanced energy systemsAdvanced smoke management systemsLaparoscopic surgical instrumentsResponsibilities: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. If you enjoy working in a cross-functional and fast-paced team environment, we invite you to apply for consideration!Required Qualifications:B.S. in Mechanical, Biomedical Engineering, or highly related field required5 years related experience in product development engineering with a bachelor’s degree; 3 years with a master’s degreeIntermediate skills in 3-D CAD software such as SolidWorks or equivalentExperience working in a regulated environment, such as FDA 21 CFR 820 or similarStrong understanding of design controls (21 CFR 820.30), ISO 13485, ISO 14971, and IEC/ISO standards related to the product typeExperience working with small/medium cross-functional teamsPreferred Qualifications:Intermediate technical writing skillsExperience overseeing engineers as a technical leadBasic knowledge with using GD&T and creating engineering drawingsIntermediate knowledge of designing for manufacturing, such as machining, injection molding, and assemblyIntermediate knowledge of statisticsIntermediate knowledge of project management principles and budgetingStrong knowledge in root cause investigations and problem solvingThis position is not eligible for employer based sponsorship.Disclosure as required by applicable law, 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.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.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. Please submit your application as soon as possible as we will be reviewing applications on a rolling basis as we receive them.Benefits:CONMED offers a wide array of benefits to fit your unique needs. Visit our Benefits Page for more information.Competitive compensationExcellent healthcare including medical, dental, vision and prescription coverageShort & long term disability plus life insurance - cost paid fully by CONMEDRetirement Savings Plan (401K) - CONMED matches your contributions dollar for dollar, with the potential for up to 7% per pay periodEmployee Stock Purchase Plan - allows stock purchases at discounted priceTuition assistance for undergraduate and graduate level coursesKnow someone at CONMED? Have them submit you as a referral before applying for this position to be eligible for our Employee Referral Program incentives!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.