Job Description Summary

IPD (Infusion Preparation and Delivery) Platform Engineering team is seeking a passionate individual for leading product life cycle management, value engineering and line extensions of disposable infusion products. This individual will be responsible for leading cross-functional teams in developing and implementing robust and sustainable design solutions. The role involves end-to-end product development including project leadership and technical execution through proper design controls. The successful candidate will be a detail-oriented self-starter with agile mindset and excellent interpersonal skills.

Job Description

We are the makers of possible 

 

BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities. 

 

We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us. 

Key Responsibilities

• Define, plan, and drive timely execution of product development activities through implementation.

• Develop deep understanding of use cases, user and stakeholder needs, compliance standards and translated system requirements.

• Down-select design solution by driving feasibility/engineering confidence testing.

• Proactively identify and resolve technical risks using systematic problem-solving, application of engineering first principles, and statistical methods of analysis.

• Lead design verification and validation testing including test method development, fixture design, and test method validation.

• Lead and assist teams in Risk Management activities including hazards analysis and FMEAs.

• Create and maintain design control documentation in compliance with BD quality policies, procedures, and practices.

• Manage tolerance stack-ups, error budgets, cost models.

• Enable frequent communications and timely escalation to ensure effective cross-functional collaboration, alignment, and leadership support in resolving challenges.

• Be a strong advocate of DFSS (Design for Six Sigma) principles and their application to product development activities as appropriate.

• Mentor junior engineers and technicians.

Minimum Qualification

• Bachelor of Science – Mechanical Engineering, Biomedical Engineering, or similar field with emphasis on mechanical design and development

• Minimum of 5 years of post-educational product design and development experience

• Solid understanding of regulatory standards applicable to design of medical devices, including FDA QSR 21 CFR 820, ISO 13845, ISO 14971, IEC 60601, and collateral standards.

Skills/Competencies

• Strong project and technical leadership experience.

• Experienced in SolidWorks.

• Proficient in design control process.

• Experienced in requirements engineering, hazards analysis, FMEA/FTA, verification, and validation.

• Strong engineering fundamentals, analytical ability, and demonstrated problem-solving skills.

• Background and experience in Design of Experiments and statistical methods of analysis.

• Experienced in leading/working in cross-functional (R&D, marketing, sales, clinical, regulatory, operations etc.) environment toward effective collaboration and coordination.

• Excellent verbal and written communication skills.

• Ability to work independently.

• Ability to manage multiple projects of varying scopes at once.

Plus Factors

• Master of Science or PhD

• Prior experience in medical device industry, medical device design controls, ISO standards.

• Prior experience in injection molding, plastic extrusion, DFM for high volume manufacturing.

• Hands-on experience with Design for Six Sigma (DFSS) and Critical Parameter Management tools.

• Experienced in modeling, simulations, and sensitivity analyses.

• Experienced in SAP, CAD PLM.

For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD’s Workplace Accommodations Polic