Senior Mechanical Engineer - Sustaining

Senior Mechanical Engineer – Advanced Surgical R&D, Denver, CO.

• Sustain high-quality, reliable disposable and/or capital medical products for surgical procedures, ensuring exceptional performance and adherence to industry standards while maintaining consistent product continuity for our customers.
• Assume full responsibility for all phases of design, development, component procurement, assembly, verification, validation, and manufacturing, ensuring compliance with medical device standards and regulations.
• Conduct and oversee thorough investigations to identify root causes of product issues and implement corrective and preventative actions.
• Oversee conceptual designs, detailed designs, CAD modeling, prototyping, and troubleshooting, working independently across all aspects of the product development cycle.
• Independently develop test protocols, comprehensive reports, and compelling presentations related to design activities, demonstrating expertise and precision.
• Conduct thorough verification and validation testing to ensure reliability and compliance.
• Lead high-performance, cross-functional project teams.
• Strategically partner with customers to gain deep insights into their needs and meticulously define project requirements, ensuring precision and alignment with their expectations.
• Guarantee that all designs comply with relevant industry standards, safety regulations, and quality control procedures.
• Communicate technical concepts and design solutions to stakeholders, including senior management and customers.
• Demonstrate deep mastery of core engineering principles.
• Actively mentor and support the development of fellow team members.
• Assist with quality management system reviews and participate in external audits to ensure compliance and continuous improvement.
• Contribute to procedural updates and best practices and develop job aids for other engineers to utilize in completion of common to complex job functions.

• 8+ years engineering work experience (6+ years with a related Master’s degree or 3+ with a PhD)
• B.S. in Mechanical Engineering (or highly related field) required

• Mastery of 3-D CAD software such as Solid Works or equivalent
• Proficiency using GD&T and creating engineering drawings
• Expertise in mechanical design principles, including stress analysis and materials selection
• Strong knowledge of design for manufacturing, such as machining, injection molding, and assembly
• Strong technical writing skills
• High level knowledge of statistics
• Experience leading cross-functional and technical teams

• Experience working in a regulated environment, such as FDA 21 CFR 820 or similar
• Strong knowledge of FEA / CFD tools
• Strong understanding of medical device regulations
• Strong knowledge in root cause investigations and problem solving
• Mastery of project management principles and budgeting
• Experience sustaining active products, either in R&D or Manufacturing

This position is not eligible for employer based sponsorship.

Disclosure as required by applicable law: the annual salary range for this position is $105,000 - $140,000. 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.