Senior Engineer, Product Development

Becton Dickinson Medical Devices • San Diego, CA

6d • Onsite

About The Position

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. Job Description: Research and Development Engineering is responsible for development and lifecycle management of products through medical device design control processes and good engineering and documentation practices. The Infusion Preparation and Delivery (IPD) platform seeks a hardworking and passionate leader to develop and drive technical strategies. Demonstrates working knowledge of Engineering principles and its application in solving standard technical problems. Demonstrates working knowledge of product design, development, and design control process. Develops technical plans for design inputs and outputs, conducts analytical and empirical feasibility studies, develops test methods to verify and validate subsystems and systems in order to transfer designs alongside Manufacturing. Demonstrates knowledge to provide design documentation to support global Regulatory filing strategies. Applies basic statistical techniques and utilizes design of experiments with moderate guidance. Collaborates within a cross-functional team to plan, develop, modify, implement, and support IPD products through the application of rigorous engineering practices. Works with moderate guidance to achieve project objectives. Flexible work arrangements allow our team members to collaborate remotely and onsite to experiment, discover, create, and simply connect with others toward a common purpose. R&D engineers are responsible for leading and supporting projects as part of a cross-functional global team. This is a highly collaborative position and requires excellent leadership, verbal, and written communication skills. Projects will involve requirements definition, developing test methods, writing test protocols, reports, executing verification testing, solving test or design issues and other types of mechanical engineering activities. Position will be required to be in the lab and office more than 80% of the time in San Diego or Brea, CA.

Requirements

• BS – Mechanical Engineering, Materials Engineering or Biomedical Engineering
• Professional experience 6 years leading or supporting product development projects
• Experience with implementing product changes through a structured, phase-gated product development process
• Experience solving problems, provides detailed insight and constructive criticism in complex situations, and foresees problems along with potential solutions
• Experience with medical device design control processes and creating and maintaining design control documentation.
• Strong project management on multiple projects cross functionally
• Experience leading or as part of a cross-functional team with members from marketing, sales, clinical, regulatory, medical affairs, quality, manufacturing, etc.
• Able to manage multiple projects of varying scopes in parallel demonstrating influential leadership and team building skills.
• Knowledgeable in SolidWorks or equivalent CAD tool
• Knowledgeable working with regulatory standards
• Working knowledge of regulatory standards applicable to design of medical devices, including FDA QSR 21 CFR 820, ISO 13845, ISO 14971 and IEC 60601 and collateral standards highly desired

Nice To Haves

• Graduate degree in Mechanical Engineering, Biomedical Engineering or related field
• 4+ years of post-educational experience in Medical Device Design highly desired
• Design for Six Sigma, Design for Manufacturability training / experience highly desired
• Experience with injection molded plastics and design of high-volume disposables highly desired
• Experience as lead in the development of medical disposable devices highly desired
• Proficiency with basic statistical techniques including familiarity with analysis of variance (ANOVA) and design of experiment (DOE) methodologies highly desired
• Expertise in common risk management techniques highly desired
• Experience in modeling, simulations using Finite Element Methods [Eg: ABAQUS] and sensitivity analyses
• Experience in development using cross-functional teams ideally in a healthcare, medical technology or life sciences area highly desired
• Able to think critically and work with moderate guidance in own area of knowledge.
• Excellent written & verbal communication skills
• Ability to learn and adapt quickly to multiple and competing requests.
• Must be comfortable making practical assumptions with engineering justifications, where needed.
• Ability to work independently, under pressure and time constraints.
• Effective interpersonal and collaborative skills.
• Deals with ambiguity, making practical assumptions with engineering justification where needed
• Masters the technical skills, knowledge and tasks associated with the role

Responsibilities

• Lead R&D deliverables throughout the medical device design control process for intravenous infusion sets and connection devices
• Collaborate within a cross-functional team to plan, develop, modify, implement, and support IPD products through the application of rigorous engineering practices
• Engineer robust products through strong understanding and application of engineering fundamentals and DFSS principles.
• Develop technical plans and guide the team to develop design inputs, conduct analytical and empirical feasibility studies, refine product configurations and designs, verify and validate subsystems and systems, concurrently transfer designs alongside Manufacturing and Operations, and provide design documentation to support global Regulatory filing strategies
• Execute design verification testing to confirm design outputs meet design input requirements.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees