Principal R&D Engineer – Product Development

About the role

Treace is seeking a Principal Research & Development Engineer to lead the design and launch of innovative medical devices for bunion surgery. You will own end‑to‑end product development, from concept generation through full production, while mentoring a multidisciplinary engineering team.

Key responsibilities

• Lead concept creation, project planning, and execution of design stages.
• Develop prototypes, ensure design for manufacturability (DFM) and design for inspection (DFI).
• Conduct risk assessments, pilot production runs, and formal design reviews.
• Author verification and validation protocols, perform physical testing, and produce detailed reports.
• Manage pre‑production and full production launch activities.
• Collaborate with sales, marketing, and customers to translate surgeon feedback into production‑ready products.
• Maintain compliance with Treace’s design quality system and relevant ISO standards.

Required profile

• Expertise in CAD (preferably SolidWorks) and creation of ASME Y14.5‑compliant drawings.
• Strong background in balancing manufacturability, reliability, and cost.
• Advanced analytical skills, including FEA simulation and material selection.
• Excellent communication skills for presenting schedules, budgets, designs, and test results.
• Customer‑centric mindset with experience gathering and acting on surgeon feedback.
• Hands‑on experience in cadaver work, surgical environments, and research experiments.
• Proven ability to work cross‑functionally and produce thorough design documentation for medical devices.

Required skills

• SolidWorks CAD modeling
• Parametric model creation
• ASME Y14.5 drawing standards
• Finite Element Analysis (FEA)
• 3D printing for prototyping
• Design for manufacturability (DFM)
• Design for inspection (DFI)
• Risk assessment methodologies
• Verification and validation protocol development
• ISO medical device standards
• Material selection and testing
• Manufacturing methods and inspection techniques