Senior Design Engineer (in office - Traverse City, MI)

Description: Thompson Retractor has an opportunity for a Senior Design Engineer. The Senior Design Engineer is responsible for the design and development of Surgical Instruments and the creation of documentation in the support of quality systems. We’re an energetic company and looking for a passionate individual to join our organization and enhance our data foundation. Thompson is employee-owned, and vested employees automatically receive company shares.

Responsibilities:

• Develop accurate 2D and 3D CAD drawings in Solidworks based on project specifications, design requirements, and input from project teams. Maintain and update revisions of drawings and R&D documentation as required.
• Provide guidance and mentorship to less experienced designers, helping them grow their skills in CAD, design principles, and design for manufacture.
• Apply, implement, and interpret Geometric Dimensioning & Tolerancing (GD&T).
• Support or lead activities to confirm that the product meets design inputs and user needs through rigorous testing and validation.
• Ensure adherence to design control processes, including traceability of requirements, design reviews, and design history file documentation.
• Support Risk Mgmt. activities and deliverables to include Use, Design and Process Failure Mode Effects Analysis (FMEA) and Product Hazard Analysis (PHA) in accordance with ISO 14971 and other applicable standards.
• Oversee prototype fabrication internally and at suppliers.
• Develop and approve design documentation for the manufacture of products including drawings, BOM’s, and product specifications.

Requirements:

• BS in Mechanical Engineering or equivalent degree or experience.
• Minimum of 5 years experience in product design or related field; preferably with a medical device company
• Intermediate to advanced 3D CAD skills (Solidworks - Modeling & Drawings)
• Rapid prototyping knowledge
• Good understanding of Design Controls in a regulated industry
• Demonstrated ability to create concepts from brief customer requirements
• Excellent written and verbal communication skills
• Excellent research, problem-solving and learning skills
• Must be aware of hazards within the company; adhere to quality and safety standards established by FDA and other regulatory agencies
• Demonstrated ability to manage projects and designs from concept through full production launch
• Ability to travel (approximately 10%) to vendor and customer locations with valid driver’s license and by air.

To apply, please send a resume to human_resources@thompsonsurgical.com

EEO/AA