R&D Engineer, Sports Life Cycle Management

DePuy Synthes is a member of Johnson & Johnson's Family of Companies is recruiting for a R&D Engineer, Sports Life Cycle Management in Raynham, MA.

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.depuysynthes.com.

Overall Responsibilities

Support and lead Life Cycle Management of implants and instrumentation and/or regionalized launches within a cross-functional project team. This includes communication with vendors, surgeons and sales consultants, understanding of clinical issues, understanding of the design parameters, and ensuring the correct product is provided to the customer.

Position Duties and Responsibilities:

The R&D Engineer will be responsible for the design and development aspects of a project, participating on cross-functional project teams through all phases of the post launch product life-cycle, and assisting the project leader with planning and executing projects or portions of a project through product launch, commercialization, and post market surveillance.

Under general direction and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, key responsibilities for this position include:

• Work with manufacturing engineering and/or suppliers to optimize designs for manufacturability and assembly to produce functioning prototypes and supporting production documentation.
• Demonstrate proficiency in the application of design controls and development processes, and support the project leader with aspects of the project management functions including scope definition, and contingency planning.
• Perform complaint investigations and field investigation activities in support of patient/customer safety.
• Perform quality/compliance activities in support of audits, remediation projects, non-conformances, regulatory compliance projects.
• Support Operations projects associated with Cost Improvement Projects and Production Transfers.
• Performs other special projects and functions as assigned.
• Know and follow all laws and policies that apply to one's job, and maintain the highest levels of professionalism, ethics and compliance at all times.
• Diligently participate in our compliance program-related activities as denoted by your supervisor or our Chief Compliance Officer.
• Responsible for communicating business related issues or opportunities to next management level
• For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable
• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures

Qualifications

Education:

• Bachelors degree in Mechanical Engineering, Biomedical Engineering, or equivalent with a minimum (2) years of experience in the design and development of medical devices, mechanical products, or biomechanical systems is required

Required Skills & Experience:

• Understanding of various types of manufacturing, mechanisms, materials, proper tolerancing, drafting standards, and GD&T
• Demonstrated ability to prioritize tasks and manage a varied workload
• Ability to perform duties in accordance with policies and procedures and in to comply civil rights requirements
• Excellent problem solving, decision-making, and root cause analysis skills.
• Proficiency utilizing the MS Office Suite (Word, Excel, PowerPoint, project etc.)

Preferred Skills & Experience:

• Experience with CAD software (Pro-E, Creo, Solidworks, etc.)
• Experience in medical device industry and knowledge of Regulatory Design Controls
• Demonstrated success in bringing product from design through introduction on time
• Strong working knowledge of QSR (21 CFR 820) and ISO (13485, 14971) quality requirements
• Excellent problem solving, decision-making, and root cause analysis skills
• Proven track record implementing Quality System improvements to meet compliance and overall business goals
• Blueprint literacy including GD&T

Other:

• This position is based in Raynham, MA and requires up to 15% travel

Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.

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