Product Development Engineer – Cases & Trays

6317-Synthes USA Products, LLC Legal Entity; West Chester (Chester County); On-site; USD 78,000 - 127,000; Full time

Job summary

Johnson & Johnson’s Orthopaedics team in West Chester, PA seeks a Product Development Engineer for Cases & Trays to drive design, verification, and lifecycle programs. You will collaborate with Design Engineering, Quality, Regulatory, Supply Chain, Manufacturing and external suppliers to translate requirements into robust, manufacturable solutions.

The role emphasizes cross-functional teamwork, prototyping, test planning and design transfer, with a focus on surgical cases and trays across

Qualifications

• Bachelor's degree in engineering (mechanical/biomedical) required.
• Experience in medical devices/orthopedics preferred.
• Understanding of GD&T and engineering drawings.
• Experience with prototyping, testing and documentation.
• Ability to coordinate with manufacturing partners and external suppliers.

Responsibilities

• Translate product and user requirements into robust Case & Trays solutions.
• Support design evaluations, reviews, and risk management activities.
• Coordinate engineering activities with Design Engineering, Quality, Regulatory, Supply Chain and suppliers.
• Develop engineering deliverables and maintain documentation per design controls.
• Support product transfer to production and ongoing lifecycle improvements.

Skills

Mechanical engineering

Biomedical engineering

Product development

GD&T

Technical communication

Cross-functional teamwork

Manufacturing collaboration

Education

Bachelor's degree in Mechanical/Biomedical Engineering or related field

Tools

Creo

Windchill

PLM systems

Job description

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function: R&D Product Development

Job Sub Function: Biomedical Engineering

Job Category: Scientific/Technology

All Job Posting Locations: West Chester, Pennsylvania, United States of America

Job Description: About Orthopaedics Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Are you passionate about improving and expanding the possibilities of Orthopaedics? Ready to join a team that’s reimagining how we heal? Our Orthopaedics teams help keep more than 6 million people moving each year while delivering clinical and economic value to surgeons and healthcare systems. Our teams build solutions for joint reconstruction; trauma and craniomaxillofacial; sports, extremities, and elective foot and ankle; spine; and robotics and digital surgery. Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech We are searching for Product Development Engineer to be based out of West Chester, PA Or Zuchwil, Switzerland. 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.

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 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, 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.

Required Qualifications

• 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 and 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 and 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 Orthopaedics business to establish a standalone Orthopaedics 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.

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law.

We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Required Skills: Preferred Skills: AI Judgement Integration, Analytical Reasoning, Bioinformatics, Biological Engineering, Biological Sciences, Biostatistics, Coaching, Data Savvy, Detail-Oriented, Feasibility Studies, Inventory Management, Preclinical Research, Project Schedule, Prototyping, Research and Development, Researching, SAP Product Lifecycle Management, Technologically Savvy

The anticipated base pay range for this position is : $78,000.00 - $126,500.00

Additional Description for Pay Transparency: Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company’s long-term incentive program.

Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits: Vacation -120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado -48 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year Holiday pay, including Floating Holidays -13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child Bereavement Leave - 240 hours for an immediate family member: 40 hours for an extended family member per calendar year Caregiver Leave - 80 hours in a 52-week rolling period10 days Volunteer Leave - 32 hours per calendar year Military Spouse Time-Off - 80 hours per calendar year For additional general information on Company benefits, please go to: https://www.careers.jnj.com/employee-benefits