Sustaining R&D Engineer

Johnson & Johnson Innovative Medicine•West Chester, PA

4d•Hybrid

About The Position

The Sustaining R&D Engineer helps lead the design and development of new implants and instrumentation and/or support in-market products through their product life-cycle within a cross-functional project team. This includes communication with customers, e.g. Health Care Professionals and marketing, understanding of clinical issues, defining the design parameters, and ensuring the product, which is provided to the customer, meets the functional requirement.

Requirements

Bachelor’s degree in Engineering or related discipline required.
Minimum of 2 years of experience in design and development of medical devices, mechanical products, or biomechanical systems.
Mechanical design experience, including exposure to design controls and development engineering.
Strong understanding of mechanical design principles, materials, manufacturing processes (particularly machining), tolerancing, drafting standards, and GD&T.
Demonstrated ability to execute project responsibilities, manage multiple priorities, and overcome technical challenges.
Strong problem‑solving, decision‑making, and root cause analysis skills.
Effective written and verbal communication skills, including the ability to communicate technical concepts across functions and with Health Care Professionals.
Proficiency with Microsoft Office (Word, Excel, PowerPoint).
Ability to work with wet tissue/cadaver labs and within an operating room environment.
Ability to travel at least 10%

Nice To Haves

Mechanical Engineering degree or demonstrated mechanics focus preferred.
Knowledge of biomechanics, anatomy, and biology.
Familiarity with orthopedic or TECA product portfolios.
Experience with MDR/FDA regulations, including 510(k) submissions and/or IDE clinical studies.
Proficiency with CAD tools (e.g., Creo/ProE).
Six Sigma Green Belt certification.
Experience with design verification/validation, DFMEA/PFMEA, and process validation.
Experience with implantable medical devices and/or plastic injection molding and design for manufacturability.
Prior project management experience.
Exposure to GMP, QSR, ISO, and good documentation practices (GDP).

Responsibilities

Lead and execute design and development activities across the product life cycle, from concept through commercialization and post‑market support, as part of cross‑functional project teams.
Technically support and partially lead projects with oversight, partnering closely with the Project Leader and Project Core Team (Marketing, Quality, Manufacturing, Supply Chain, Regulatory).
Define and develop product requirements and design concepts through collaboration with internal teams and Health Care Professionals.
Create CAD designs, layouts, and tolerance analyses using GD&T; solve design challenges using prototyping, FEA, and simulated‑use, dry, and wet lab testing.
Develop and execute design verification and validation plans, methods, and protocols; analyze results and author technical reports.
Ensure compliance with MDR, FDA Design Controls, and global regulatory requirements, including support of 510(k) submissions, IDE studies, audits, and inspections.
Apply Six Sigma and structured problem‑solving methodologies to resolve complex technical issues.
Support supplier, manufacturing, and operations teams to optimize designs for manufacturability, assembly, cost improvement, and production transfers.
Engage Health Care Professionals to define user needs, evaluate prototypes, and support clinical follow‑up while maintaining awareness of surgical trends.
Support intellectual property reviews for freedom to operate and assist with budget‑related responsibilities as applicable.
Participate in complaint investigations, field actions, non‑conformance remediation, and other quality and compliance‑related activities.
Promote and adhere to the highest standards of professionalism, ethics, safety, and compliance in accordance with company policies and regulations.
Perform special projects and additional duties as assigned.