Senior Manufacturing Design Engineer-Orthopaedics

Key Responsibilities

• Design and release production tooling, jigs, fixtures, gauges, and test/assembly stations that enable safe, repeatable, high-yield manufacturing processes and line changeovers.
• Produce complete 3D CAD models and drawings using advanced CAD (CREO/SolidWorks) with full manufacturing detail, material callouts, finish specs, and vendor-ready notes.
• Create and maintain fixture-specific BOMs, parts lists, hardware lists, and wiring/cable lists for electro-mechanical test fixtures and automated stations.
• Apply GD&T, tolerance stack-ups, and basic tolerance analysis to ensure part location, repeatability, and interchangeability of fixtures under production loads.
• Use hand calculations and, when required, FEA or simulation to validate fixture stiffness, clamp loads, deflection, and safety margins for production cycling.
• Lead prototype builds and pilot trials using 3D printing or CNC machining: assemble fixtures, run first-article/functional checks, capture lessons learned, and iterate designs to meet cycle-time, ergonomics, and quality targets.
• Work alongside electrical engineers to develop or revise electrical schematics/drawings for test fixtures used in end of line or in-process testing.
• Collaborate with manufacturing, quality, process engineering, and operators to verify manufacturability, operator ergonomics, maintenance access, and serviceability of tooling designs.
• Prepare and maintain tooling drawings, CAD models, acceptance criteria, and qualification documents to support FAI/PPAP and production qualification activities.
• Lead supplier communication and technical guidance for tool fabrication: define tolerances, surface treatments, inspection requirements, and support vendor design reviews and shop tryouts.
• Define preventive maintenance plans, spare-part lists, and training materials for production technicians to improve fixture uptime and simplify troubleshooting.
• Support root-cause analysis and corrective actions for tooling-related failures; implement design improvements to reduce setup time, scrap, and rework.
• Ensure all drawings, CAD models, BOMs, and specifications align with applicable local and international standards (e.g., ASME, ANSI, ISO) and internal drawing/procurement procedures.
• Assist in implementing and maintaining documentation and regulatory requirements relevant to tooling (e.g., QSR, ISO 13485, RoHS, UDI considerations where fixtures interact with finished medical devices).
• Create photorealistic renderings or annotated illustrations (exploded views) of fixtures for work instructions, operator training, maintenance guides, and supplier quotations.
• Provide responsive CAD application support and one-on-one training for engineers and technicians on fixture design, standards, and company drawing conventions.
• Produce well-documented design records and follow Good Documentation Practices (GDP) and change control processes for all tooling and fixture designs.
• Represent the tooling and fixture subject area in multi-discipline design reviews and manufacturing readiness meetings; propose pragmatic engineering solutions that balance cost, quality, and manufacturability.
• Self-direct workload and priorities; mentor junior designers/technicians and contribute to SOPs, templates, and process improvements related to fixture design and part lifecycle management.

Qualifications

Education: Bachelor's degree or master's degree in engineering or a related field.

Experience and Skills: Required: Minimum of 7 years of job experience in advanced CAD design and drafting or similar engineering position. Preferred: Experience working in the medical device industry. Certificate or degree in 3D modeling (CAD). Solid understanding of geometric dimensioning & tolerancing (GD&T). Physical requirement of lifting up to 40 lbs.

Other: English language proficiency is a requirement for this role. Less than 10% travel is expected for this role.