SENIOR PRODUCT DEVELOPMENT ENGINEER

DePuy Synthes, a member of the Johnson & Johnson Family of Companies, is currently hiring for a Senior Product Development Engineer, R&D.
This position will be based in Palm Beach Gardens, Florida, or Raynham, MA.
The Johnson & Johnson Medical Devices Companies have been working to make surgery better for more than a century.
With substantial breadth and depth in surgical technologies, orthopedic and interventional solutions, we aspire to improve and enhance medical care for people worldwide.
Together, we are working to shape the future of health through differentiated products and services.
DePuy Synthes, part of the Johnson & Johnson Medical Devices Companies, provides one of the most comprehensive orthopedics portfolios in the world.
DePuy Synthes solutions, in specialties including joint reconstruction, trauma, craniomaxillofacial, spinal surgery and sports medicine, are designed to advance patient care while delivering clinical and economic value to health care systems worldwide.
For more information, visit www.
epuysynthes.
om.
Johnson & Johnson Medical Devices is focused on shaping the future of digital surgery and expanding its robotics and digital solutions offerings across the entire portfolio, with multi-specialty, end-to-end solutions in orthopedics, endoluminal intervention and general surgery.
This includes the Power Tools and VELYS platform, where we are building connected technologies powered by data insights before, during, and after surgery and designed to elevate the orthopedic experience for patients, surgeons, and care teams.
The Senior Product Development Engineer will utilize tools and methods for the effective and efficient development, transfer, and maintenance of products/processes throughout the product lifecycle.
The incumbent will also utilize electromechanical principles and problem-solving skills to develop and optimize products/processes that are aligned with the overall Product Development vision.
They will ensure effective risk management to prevent unanticipated failure modes and improve the capability of processes.
Key Responsibilities.
You will be employed in Product Development Engineering for the Power Tools team, including responsibility for the design and documentation of products on the market.
Your work has a direct impact on our patients and users.
In this position, you will be responsible for the lifecycle management of electro-mechanically powered surgical instruments and their accessories, including batteries and chargers.
Other Tasks Include.
Product Development team member focused on lifecycle management activities associated with Power Tools and Velys products.
Consultant in product development-related operations and quality systems applicable to the products and processes in support of day-to-day manufacturing processes.
Provides guidance and recommendations as needed.
Contact person for technical project inquiries or issues for existing products, including coordination of technical project partners.
Responsible for product design, product specification, and documentation for existing products.
Conduct stakeholder analysis to ensure that customer CTQs are known and adequately addressed in control plan.
Collaborate with the lifecycle management team to guide the application of design change controls and risk management while assessing the effect of changes on design input, design outputs, failure modes, test methods, and design verification and validation activities.
Develop measurement systems/capabilities, destructive tests, and non-destructive tests for manufacturing processes.
Ensure compliance with Medical Device regulations and standards, including Design Control Regulatory requirements, in worldwide markets for product design and supplier changes.
Responsible for generating necessary product development documents to ensure compliance with national and international regulations in the medical technology sector (in particular, EUMDR, US FDA, and Japanese PAL).
Support internal and external regulatory compliance audits and drive continuous improvement in quality systems execution across the company.
Know and follow policies regarding the code of conduct, ethics and compliance programs, and other relevant regulations.
Qualifications Education.
Minimum of Bachelor’s in Mechanical Engineering, Biomedical Engineering, or other related Engineering degree required.
Advanced degree preferred.
Experience and Skills.
Required.
5+ years of experience in the development and design of mechanical or electromechanical devices.
Deep knowledge of drive and/or battery technology.
Proven experience in the industrialization of products.
Excellent problem-solving, root-cause investigation, and decision-making skills.
Strong in communication with internal and external partners at various levels.
Preferred.
Experience in medical technology or a regulatory-relevant.
Experience in power tools.
Experience in approval according to IEC and EN .
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer.
We are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
The anticipated base pay range for this position is $ to $.
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