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We are searching for the best talent for a Product Development Engineer – Cases & Trays role.
Purpose
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.
The engineer works closely with Product Development, Design Engineering, Quality, Regulatory, Supply Chain, Manufacturing, Marketing, and external suppliers to translate product and user requirements into robust, manufacturable Cases & Trays solutions.
The role supports projects throughout the product development lifecycle, from early concept and product configuration through detailed development, verification, supplier qualification, design transfer, and product launch.
You will be responsible for
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 to reduce development time, complexity, and unnecessary new SKUs.
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 the appropriate 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.
Qualifications and Requirements
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.
Preferred Qualifications
Experience with surgical Cases & Trays, instruments, implants, sterilization containers, or reusable medical-device systems.
Knowledge of cleaning, sterilization, reprocessing, transportation, handling, and product-protection considerations for reusable surgical systems.
Experience with PCT Creo or equivalent 3D CAD software.
Experience with Windchill or another PLM system.
Working knowledge of GD&T and tolerance analysis.
Familiarity with design verification, validation, design transfer, and supplier qualification.
Experience working with external suppliers and geographically distributed engineering teams.
Familiarity with medical-device design controls and risk-management processes.
Johnson & Johnson announced plans to separate our Orthopedics business to establish a standalone orthopedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals.
Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes, and your employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes.
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Required Skills
Preferred Skills
