Product Development Engineer, Cases & Trays

About the Role

The Product Development Engineer – Cases & Trays is responsible for supporting the design, development, verification, and commercialization of surgical case and tray solutions for new product development and lifecycle programs. This role collaborates with various teams to translate product and user requirements into robust, manufacturable Cases & Trays solutions. The position supports projects throughout the product development lifecycle, from concept through product launch.

Key Responsibilities

Cases & Trays Product Development

• Support the development of surgical cases, trays, caddies, brackets, inserts, and related components for implant and instrument systems.
• Translate product, clinical, reprocessing, manufacturing, and user requirements into practical Cases & Trays solutions.
• Develop case and tray concepts and configurations considering product grouping, capacity, instrument positioning, retention, stacking, handling, cleaning, and sterilization requirements.
• Partner closely with Design Engineering resources to develop layouts, concepts, CAD models, drawings, prototypes, and production-ready designs.
• Support design evaluations and recommend solutions that balance product protection, usability, reprocessing, manufacturability, cost, weight, and system complexity.
• Leverage existing designs, standardized architectures, and lessons learned where appropriate.

Product Development & Project Execution

• Execute assigned engineering activities throughout the product development lifecycle.
• Develop and maintain engineering deliverables, schedules, technical documentation, and project actions.
• Identify technical risks, issues, and dependencies and communicate them to project stakeholders.
• Participate in technical and design reviews and drive assigned actions to completion.
• Coordinate engineering activities across Product Development, Design Engineering, Quality, Supply Chain, Manufacturing, and external suppliers.
• Support prototype development, testing, design iterations, and technical assessments.
• Communicate project status, technical issues, and recommendations clearly to project and functional stakeholders.
• Manage multiple engineering priorities while maintaining quality and project commitments.

Supplier & Manufacturing Collaboration

• Work directly with external Cases & Trays suppliers throughout product development.
• Communicate technical requirements, design intent, quality expectations, and project deliverables.
• Support supplier technical assessments, design reviews, prototype builds, manufacturability reviews, quotation activities, and qualification.
• Collaborate with suppliers and internal partners to identify opportunities to improve manufacturability, assembly, quality, lead time, and cost.
• Support investigation and resolution of supplier-related technical issues and nonconformances.
• Support the successful transfer of designs into stable production.

Design Controls & Product Realization

• Execute product development activities in accordance with applicable design controls, quality systems, and Product Realization processes.
• Develop and maintain appropriate engineering documentation supporting design inputs, outputs, reviews, risk management, verification, validation, and design transfer.
• Develop or support test protocols, engineering evaluations, reports, specifications, drawings, and other technical documentation.
• Participate in product and process risk-management activities and support implementation of risk controls.
• Support design verification and validation activities, including test planning, sample coordination, execution, data review, and report preparation.
• Support engineering change activities throughout development and following product launch.
• Maintain appropriate design traceability and ensure assigned technical documentation is completed accurately and on schedule.

Requirements & Tech Stack

• Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Product Design Engineering, or a related engineering discipline.
• Product development or engineering experience, preferably within medical devices, surgical instruments, orthopedics, or another regulated industry.
• Experience applying engineering principles to the development of mechanical products or systems.
• Understanding of engineering drawings, dimensional requirements, tolerances, and GD&T.
• Experience with engineering testing, technical documentation, and structured problem-solving.
• Ability to work effectively with manufacturing partners and external suppliers.
• Strong written, verbal, presentation, and cross-functional communication skills.
• Ability to manage assigned engineering activities with appropriate guidance while actively driving issues to resolution.
• Experience with surgical Cases & Trays, instruments, implants, sterilization containers, or reusable medical-device systems is preferred.
• Knowledge of cleaning, sterilization, reprocessing, transportation, handling, and product-protection considerations for reusable surgical systems is preferred.
• Experience with PCT Creo or equivalent 3D CAD software is preferred.
• Experience with Windchill or another PLM system is preferred.
• Working knowledge of GD&T and tolerance analysis is preferred.
• Familiarity with design verification, validation, design transfer, and supplier qualification is preferred.
• Experience working with external suppliers and geographically distributed engineering teams is preferred.
• Familiarity with medical-device design controls and risk-management processes is preferred.