Senior Research & Development Engineer

Johnson & Johnson Innovative Medicine•West Chester, PA

8d•$92,000 - $148,350•Hybrid

About The Position

Johnson & Johnson is seeking a Senior Research and Development Engineer to join its Orthopaedics team in a hybrid role 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, planning, executing, and overseeing projects through launch, commercialization, and post-market surveillance. The engineer designs and develops implants and instrumentation and supports in-market products. This includes engaging with Health Care Professionals and commercial teams, understanding clinical issues, defining design parameters, and ensuring products meet functional requirements. The role also serves as a technical leader and mentor to associate and other R&D engineers, supports regulatory and quality compliance, and contributes to manufacturing and operations initiatives. The position may involve work with wet tissue or cadavers and in an Operating Room setting. Johnson & Johnson announced plans to separate its Orthopaedics business as DePuy Synthes; if the separation is completed, employment is anticipated to transition to DePuy Synthes and be governed by its employment processes, programs, policies, and benefit plans.

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 interface with Health Care Professionals and sales and marketing personnel.
Strong organizational skills supporting project management functions, including scope definition, budgeting, and contingency planning.
Excellent problem-solving, decision-making, and root-cause-analysis skills, along with interpersonal skills that foster resolution of technical conflicts.
Initiative and follow-through in executing project responsibilities, overcoming obstacles, balancing priorities, and providing technical or project leadership.
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, Health Care Professionals, customers, and teams, and to work as a technical leader and sometimes a 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, including GMP, QSR, and ISO quality requirements.
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 a technical team leader and, in some cases, project leader on cross-functional project teams.
Coordinate with engineering, marketing, quality, supply chain, manufacturing, regulatory affairs, Health Care Professionals, and other departments to define and develop product requirements and concepts.
Resolve complex design problems using CAD, prototyping, and other technologies; independently generate design concepts and prototypes.
Conduct 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.
Develop and execute design verification and validation plans and test plans to support global regulatory strategy.
Complete activities and documentation for compliance with MDR and FDA Design Control regulations and support 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, execute, or coordinate mechanical tests and scientific experiments; analyze and present data and conclusions and write technical reports.
Develop approaches to complex technical solutions, using Six Sigma methodologies where appropriate.
Apply design controls and product development processes; support project management functions including scope definition and contingency planning.
Serve as a subject matter expert on existing product lines, relevant anatomic pathologies, and treatment options.
Work with Health Care Professionals and other departments to define product requirements and concepts, conduct wet tissue or cadaver evaluations, and support clinical follow-up.
Follow the New Product Development process and maintain high-quality design verification and validation.
Act as a mentor for interns and Co-Ops.
As applicable, operate 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 projects, non-conformances, and regulatory compliance projects.
Support Operations projects, including Cost Improvement Projects and Production Transfers.
Complete other special projects and functions as assigned.
Follow applicable laws and company policies and maintain professionalism, ethics, and compliance; participate in compliance program activities as directed.
Communicate business issues or opportunities to the next management level.
If supervising or managing staff, ensure that subordinates follow Health, Safety, and Environmental guidelines and have necessary resources.
Ensure personal and company compliance with applicable federal, state, and local 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 child’s 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.