Job Details

Overview

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.

Job 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

Minimum Qualifications

• 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 13485, ISO 14971 and IEC 60601 and collateral standards highly desired

Desired Qualifications

• 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

Competencies

• 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

Work Arrangement

BD prioritizes on-site collaboration; for most roles a minimum of 4 days in-office per week is expected to maintain culture and operations. Remote or field-based arrangements will be indicated in the job posting.

Vaccination Policy

For certain roles, employment is contingent upon providing proof of full COVID-19 vaccination. In some locations, testing may be available and/or required. BD's Workplace Accommodations Policy will be applied pursuant to applicable law.

Why Join Us?

A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It's also a place where we help each other be great, we do what's right, we hold each other accountable, and learn and improve every day.

To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you'll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place.

To learn more about BD visit 102-821-XXXX

Equal Opportunity

Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to 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, and other legally-protected characteristics.

Salary

Salary Range Information

$102,000.00 - $168,200.00 USD Annual