Product Development Engineer

About the Role

We are searching for a Product Development Engineer to join our Orthopaedics team in West Chester, PA, in a hybrid role. This role focuses on the design and development aspects of projects, participating in cross-functional teams through all phases of the product life-cycle. You will assist the project leader with planning and executing projects from product launch through commercialization and post-market surveillance.

Orthopaedics at Johnson & Johnson develops smarter, less invasive, and personalized treatments, helping over 6 million people move each year. Our teams build solutions for joint reconstruction, trauma, sports medicine, spine, and robotics and digital surgery.

Responsibilities

• Technically lead design and development projects with oversight, collaborating with project leaders and cross-functional teams (marketing, manufacturing, quality, testing, supply chain, regulatory, etc.).
• Engage with Health Care Professionals and other departments to define user needs and design inputs.
• Solve design problems using CAD techniques, rapid and conventional prototyping, and other technologies.
• Develop layouts and tolerance studies using GD&T; participate in design evaluations (e.g., FEA, simulated use testing, dry labs, wet tissue/cadaver labs).
• Develop and execute design verification/validation plans, test methods, and protocols; support regulatory processes for global registration efforts.
• Generate documentation to ensure compliance with MDR, FDA Design Control regulations, and support 510(k) submissions or IDE clinical studies.
• Collaborate with supply chain, manufacturing engineering, and suppliers to optimize designs for manufacturability and assembly; produce prototypes and production documentation.
• Apply design controls and development processes; support project management functions including scope definition and contingency planning.
• Maintain knowledge of existing product lines, anatomic injuries/pathologies, and treatment options; follow the New Product Development process.
• Perform complaint investigations and field activities to support patient/customer safety.
• Support quality/compliance activities for audits, remediation projects, non-conformances, and regulatory compliance.
• Conduct initial patent reviews for freedom to operate.
• Support Operations projects related to Cost Improvement Projects and Production Transfers.
• Perform other special projects and functions as assigned.
• Adhere to all laws and policies; maintain professionalism, ethics, and compliance.
• Participate in compliance program-related activities as required.
• Communicate business-related issues or opportunities to management.
• Ensure compliance with Health, Safety, and Environmental practices for teams, if applicable.

Requirements

• Recent BS or MS in Mechanical Engineering, Biomedical Engineering, or equivalent.
• Proficiency in MS Office Suite (Word, Excel, PowerPoint, etc.).
• Strong communication and interaction skills; ability to interface with Health Care Professionals and cross-functional teams.
• “Hands-on” engineering approach.

Preferred Qualifications

• Experience with CAD software (Pro-E, Creo, Solidworks, etc.).
• Design and development experience of mechanical products through co-op, internship, or research.
• Exposure to machining of metals or a machine shop environment.
• Knowledge of biomechanics, biology, or anatomy.
• Familiarity with medical device regulations (GMP, QSR, ISO quality requirements).
• Understanding of manufacturing processes (especially machining), mechanisms, materials, tolerancing, drafting standards, and GD&T.
• Demonstrated creative design ability.

Pay

The anticipated base pay range for this position is $64,000.00 - $102,350.00.

Benefits

Subject to plan terms and date of hire, employees are eligible for the following benefits:

• Retirement and Savings: Participation in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
• Long-Term Incentive Program: Eligibility for the Company’s long-term incentive program.
• Time Off:
  • Vacation: 120 hours per calendar year.
  • Sick time: 40 hours per calendar year (48 hours for Colorado residents; 56 hours for Washington residents).
  • 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 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 period.
  • Volunteer Leave: 32 hours per calendar year.
  • Military Spouse Time-Off: 80 hours per calendar year.

For additional general information on Company benefits, visit https://www.careers.jnj.com/employee-benefits.