Job Description Summary

Job Description

The Sr. Product Development Engineer is responsible for providing design engineering technical leadership on cross-functional product development teams during the pre-concept, development, design and documentation for manufacture of new and improved disposable surgical devices, surgical implants or related medical products.  

As an independent contributor, the Sr. Product Development Engineer must be able to coordinate and implement concurrent engineering practices either within the organization during an organic product development process or when working with and external development partner. Also, the Sr. Product Development Engineer may have direct reports or must be able to guide, mentor and develop lower-level engineers and technicians.

Responsibilities:

• Contribute to developing new product designs in a cross-functional team environment requiring an ability to develop innovative solutions that address our customer needs by overcoming mechanical, materials and manufacturing process design challenges.

• Supports establishing design specification and defining the relationship between the design specifications and the critical design features, including the development of clinically relevant test methods that verify the product meeting the specifications.

• Coordinating and supporting dFMEA and component level dFMEA activities, establishing mitigation plans & executing on relevant functional testing to ensure safe and effective products are developed.

• Generate product development documentation and reports using appropriate technical writing.

• Able to design and document test fixtures utilizing CAD, and work with prototype development lab to generate prototypes.

• Schedules and conducts design review and technical review meetings.

Qualifications, Knowledge, and Skills Required:

• BS with 5+ years or MS engineering degree with 3+ years (preferably Mechanical Engineering or Biomedical Engineering), of product development-related experience required (preferably in the development of complex mechanical systems working in a team base environment).

• Background and knowledge of test method development.

• Background and knowledge of all Machine Shop practices, plastic molding and forming equipment and plastic component assembly techniques.

• Experience designing products for a high volume disposables industry.

• Broad knowledge and use of medical disposable or implantable devices.

• Ability to prioritize and multi task, while supporting multiple projects simultaneously.

• Good verbal and written communication with all levels of technical and operating management

• Experience with CAD/CAM and design analysis software (mechanisms and FEA), statistical analysis techniques, and geometric dimensioning and tolerance is preferred.

• Knowledge of current FDA medical device regulations including IDE and GMP requirements.

Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

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