Sustaining R&D Engineer

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are our expertise in Innovative Medicine and MedTech we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for more at .

As guided by Our Credo Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson we respect the diversity and dignity of our employees and recognize their merit.

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About MedTech

Fueled by innovation at the intersection of biology and technology were developing the next generation of smarter less invasive more personalized treatments.

Your unique talents will help patients on their journey to wellness. Learn more at & Johnson announced plans to separate our Orthopaedics business to establish a standalone orthopaedics company operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months subject to legal requirements including consultation with works councils and other employee representative bodies as may be required regulatory approvals and other customary conditions and approvals.

Should you accept this position it is anticipated that following conclusion of the transaction you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes programs policies and benefit that case details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes.

We are searching for the best talent for a Sustaining R&D Engineer.

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.

Key Responsibilities:

• Lead and execute design and development activities across the product life cycle from concept through commercialization and postmarket support as part of crossfunctional 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 simulateduse 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 problemsolving 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 followup while maintaining awareness of surgical trends.
• Support intellectual property reviews for freedom to operate and assist with budgetrelated responsibilities as applicable.
• Participate in complaint investigations field actions nonconformance remediation and other quality and compliancerelated 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.

Requirements:

Education

• Bachelors degree in Engineering or related discipline required.
• Mechanical Engineering degree or demonstrated mechanics focus preferred.

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 problemsolving decisionmaking 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%

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).

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity age national origin disability protected veteran status or other characteristics protected by federal state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants needs. If you are an individual with a disability and would like to request an accommodation please contact us via or contact AskGS to be directed to your accommodation resource.

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