Research & Development Engineer

Johnson & Johnson • West Chester, PA

9d • Hybrid

About The Position

The Research & Development Engineer will help lead the design and development of new implants and instrumentation and support in-market products throughout their product life cycle. Working on cross-functional project teams, the engineer will communicate with health care professionals and marketing, understand clinical issues, define design parameters, and help ensure products meet customer functional requirements. The role participates in all phases of the product life cycle and assists the project leader with planning and execution through product launch, commercialization, and post-market surveillance.

The position is part of Johnson & Johnson’s Orthopaedics team and is a hybrid role located in West Chester, Pennsylvania. The Orthopaedics organization develops treatments and solutions across joint reconstruction; trauma and craniomaxillofacial; sports, extremities, and elective foot and ankle; spine; and robotics and digital surgery. Johnson & Johnson has announced plans to separate its Orthopaedics business as DePuy Synthes; following completion of the transaction, the employee is anticipated to join DePuy Synthes under its employment processes, programs, policies, and benefit plans.

Requirements

• Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, or equivalent.
• 2–6 years of experience in the design and development of 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 or marketing personnel.
• Strong problem-solving, decision-making, and root-cause-analysis skills, and 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.
• Skills listed in the posting include bioinformatics, biological engineering, biological sciences, biostatistics, data reporting, data savvy, design of experiments, detail orientation, execution focus, feasibility studies, preclinical research, problem solving, process orientation, prototyping, report writing, research and development, researching, SAP Product Lifecycle Management, and technological savvy.

Responsibilities

• Technically lead design and development projects with oversight, working closely with the project leader and cross-functional team members from marketing, manufacturing, quality, testing, supply chain, and regulatory.
• Engage health care professionals and other functional departments to define user needs and design inputs.
• Solve design problems using CAD techniques, 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, dry labs, and wet-tissue or cadaver labs.
• Develop and execute design verification and validation plans, test methods, and protocols, and support regulatory processes for global registration efforts.
• Perform activities and generate documents required for compliance 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 develop supporting production documentation.
• Apply design controls and development processes and support the project leader with project-management activities, including scope definition and contingency planning.
• Conduct complaint investigations and field investigations in support of patient and customer safety.
• Perform 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 stated amounts 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 a child’s birth, adoption, or foster care placement.
• 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