Senior Research & Development Engineer

Johnson & Johnson•West Chester, PA

7d•Hybrid

About The Position

The Senior Research and Development Engineer joins Johnson & Johnson’s Orthopaedics team in a hybrid role based in West Chester, Pennsylvania. The role is responsible for design and development of complex systems and projects, technically leading cross-functional teams through product lifecycle phases, and often organizing and overseeing projects through launch, commercialization, and post-market surveillance. The engineer designs and develops new implants and instrumentation and supports in-market products, working with healthcare professionals and internal partners to understand clinical issues, define design parameters, and ensure products meet functional requirements. The role also serves as a technical resource, leader, and mentor to other R&D engineers. The position involves developing product requirements and concepts; solving design problems through CAD, prototyping, and other technologies; evaluating designs; and conducting design verification, validation, mechanical tests, and scientific experiments. The engineer documents clinical and surgical observations and supports regulatory and quality requirements, including design controls and submissions or clinical studies. Additional work may include patent and freedom-to-operate reviews, manufacturability improvements, complaint and field investigations, audit and compliance activities, operations projects, and budget input. The role requires collaboration across functions and with healthcare professionals, along with adherence to applicable laws, company policies, and compliance requirements.

Requirements

Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, or equivalent.
At least six years of experience designing and developing medical devices, mechanical products, or biomechanical systems, including multi-component systems.
Strong experience with CAD software such as Pro-E, Creo, or SolidWorks.
Experience identifying user needs (VOC), applying medical device design principles, selecting materials, verifying and validating design concepts, and understanding design failure modes.
Understanding of manufacturing types, mechanisms, materials, tolerancing, drafting standards, and GD&T.
Strong communication and interaction skills, including the ability to work with healthcare professionals and sales and marketing personnel.
Strong organizational skills supporting project management activities such as scope definition, budgeting, and contingency planning.
Excellent problem-solving, decision-making, and root-cause analysis skills, as well as interpersonal skills that support conflict resolution in technical situations.
Initiative and follow-through in executing project responsibilities, overcoming obstacles, and balancing priorities, supported by technical or project leadership experience.
Demonstrated success bringing products from design through introduction on time.
Demonstrated creative design ability.
Ability to work with wet tissues or cadavers and in an operating room setting.
Ability to communicate concepts, ideas, and knowledge effectively to individuals, healthcare professionals, customers, and teams, and to work effectively as a technical leader and sometimes project leader.
Excellent technical writing and communication skills.

Nice To Haves

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

Responsibilities

Serve as technical team leader and, in some cases, project leader on cross-functional project teams.
Coordinate with engineering, marketing, quality, supply chain, manufacturing, regulatory affairs, healthcare professionals, and other functions to define and develop product requirements and concepts.
Solve complex design problems using CAD, rapid and conventional prototyping, and other available technologies; independently generate design concepts and prototypes.
Perform design evaluations, including tolerance analysis, GD&T, FEA, simulated-use testing, dry labs, and wet-tissue or cadaver labs.
Document clinical and surgical technique observations to inform design solutions.
Develop and execute design verification and validation plans and test plans supporting global regulatory strategy.
Complete activities and documentation to support MDR and FDA Design Control compliance, 510(k) submissions, or IDE clinical studies.
Drive initial patent review and freedom-to-operate activities from concept through launch.
Collaborate with supply chain, manufacturing engineering, and suppliers to optimize designs for manufacturability and assembly, produce prototypes, and support production documentation.
Design and conduct or coordinate mechanical tests and scientific experiments; analyze and present results and write technical reports.
Develop approaches to technical solutions using Six Sigma methodologies, with technical guidance on unusual or complex problems.
Apply design controls and development processes, and support project management activities including scope definition and contingency planning.
Serve as a subject matter expert on existing product lines, relevant anatomical pathologies, and treatment options.
Work with healthcare professionals and other functions on requirements, concepts, prototypes, wet-tissue or cadaver evaluations, and clinical follow-up.
Follow the New Product Development process and maintain high-quality design verification and validation.
Mentor associate R&D engineers, R&D engineers, interns, and Co-Op participants.
May manage work within a budget and provide input on budget allocation and prioritization.
Carry out smaller projects of limited complexity and scope under general supervision.
Conduct complaint investigations and field investigations in support of patient and customer safety.
Perform quality and compliance activities supporting audits, remediation, non-conformances, and regulatory compliance projects.
Support Operations projects involving cost improvement and production transfers.
Complete other assigned projects and functions; follow applicable laws and policies and participate in compliance activities.
Communicate business-related issues or opportunities to the next management level.
Where applicable, ensure supervised staff follow company Health, Safety, and Environmental practices and have necessary resources.
Ensure personal and company compliance with applicable federal, state, local, and company regulations, policies, and procedures.

Benefits

Consolidated retirement plan (pension) and savings plan (401(k)), subject to plan terms.
Vacation: 120 hours per calendar year, subject to policy and date of hire.
Sick time: 40 hours per calendar year, with different amounts for employees residing in Colorado or Washington, subject to policy and date of hire.
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 a birth, adoption, or foster-care placement.
Bereavement leave: up to 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.