Mechanical Engineer III - Advanced Surgical

CONMED • Greenwood Village, CO

12d • $82,000 - $125,000 • Onsite

About The Position

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.
Advanced Surgical products include:
Advanced insufflation systems
Advanced energy systems
Advanced smoke management systems
Laparoscopic surgical instruments
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!

Requirements

• 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

Nice To Haves

• 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

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.

Benefits

• 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
• Employee Referral Program incentives

What This Job Offers

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