Research & Development Engineer

Johnson & Johnson Innovative Medicine • West Chester, PA

10d • $76,000 - $121,900 • Hybrid

About The Position

Johnson & Johnson is seeking a Research & Development Engineer to join its Orthopaedics team in a hybrid role located in West Chester, Pennsylvania. The engineer will help lead the design and development of new implants and instrumentation and support in-market products throughout their life cycle. The work involves engaging with health care professionals and marketing to understand clinical issues, define user needs and design parameters, and ensure products meet functional requirements. The engineer will contribute to cross-functional project teams through product launch, commercialization, and post-market surveillance, and assist project leaders with planning and execution.

The position includes design and development work across the product life cycle, including prototyping, tolerance studies, design evaluations, and verification and validation. The engineer will support regulatory submissions and compliance, collaborate with manufacturing, supply chain, and suppliers to optimize designs and produce prototypes and production documentation, investigate complaints and field issues, and conduct initial patent reviews for freedom to operate. The role also requires following applicable laws and policies and communicating business-related issues or opportunities to the next management level.

Requirements

• Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, or equivalent.
• 2–6 years of experience designing and developing medical devices, mechanical products, or biomechanical systems.
• Hands-on engineering experience.
• Experience with CAD software such as Pro-E, Creo, or SolidWorks.
• Understanding of manufacturing types, mechanisms, materials, proper tolerancing, drafting standards, and GD&T.
• Ability to work with wet tissues or cadavers and in an Operating Room setting.
• Demonstrated success bringing products from design through introduction on time.
• Strong communication and interaction skills, including the ability to interface with Health Care Professionals and sales and marketing personnel.
• Strong problem-solving, decision-making, and root-cause analysis skills, plus interpersonal skills that support conflict resolution in technical situations.
• Demonstrated creative design ability.
• Ability to prioritize tasks and manage a varied workload.

Nice To Haves

• Master’s degree in Mechanical Engineering, Biomedical Engineering, or equivalent.
• Experience with medical device regulations, including GMP, QSR, and ISO quality requirements.
• Ability to review and critically assess patents and other forms of intellectual property.
• Excellent technical writing and communication skills.
• Proficiency in sample-size calculation and statistical methods for analyzing data.

Responsibilities

• Technically lead design and development projects with oversight, working with project leaders and cross-functional team members.
• Engage Health Care Professionals and other functional departments to define user needs and design inputs.
• Solve design problems using CAD, rapid and conventional prototyping, and other available technologies.
• Develop layouts and tolerance studies using GD&T and participate in design evaluations, including FEA, simulated-use testing, and dry-lab, wet-tissue, or cadaver labs.
• Develop and execute design verification and validation plans, test methods, and protocols, and support global regulatory registration efforts.
• Perform required activities and generate documentation to comply with MDR and FDA Design Control regulations and support 510(k) submissions or IDE clinical studies.
• Work with supply chain, manufacturing engineering, and suppliers to optimize designs for manufacturability and assembly, produce functioning prototypes, and support production documentation.
• Apply design controls and development processes, and support project management activities such as scope definition and contingency planning.
• Perform complaint investigations and field investigations in support of patient and customer safety.
• Conduct initial patent reviews of designs for freedom to operate.
• Follow applicable laws and policies and maintain professionalism, ethics, and compliance.
• Communicate business-related issues or opportunities to the next management level.

Benefits

• Vacation: 120 hours per calendar year.
• Sick time: 40 hours per calendar year, with different allowances for employees residing in Colorado or Washington.
• 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, or foster care of a child.
• Bereavement Leave: 240 hours for an immediate family member and 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level