Senior Engineer, Product Development Engineering

Becton Dickinson NA; Irvine (CA); On-site; USD 106,000 - 169,000; Full time

Job summary

Becton Dickinson (BD) in Irvine, CA, seeks a Senior Engineer for New Product Introduction to lead transition of medical device products from design to commercial manufacturing.

You will ensure manufacturability, quality, and regulatory compliance while collaborating with R&D, Manufacturing, Quality, and Supply Chain. The role emphasizes DFMs, DFAs, validation (IQ/OQ/PQ), and continuous improvement in a highly regulated environment.

Qualifications

• Bachelor's degree in engineering required; Master's preferred.
• 4+ years in medical device manufacturing or manufacturing process development.
• Experience with DFMs (DFM) and DFAs (DFA); process validation and SPC.

Responsibilities

• Lead all technical aspects of new product introduction from concept to launch.
• Collaborate with R&D, Manufacturing, Quality, and Supply Chain to define processes.
• Participate in DFM/DFA reviews to optimize product designs for manufacturing.
• Develop manufacturing strategies including process flow, tooling design and automation.
• Oversee IQ/OQ/PQ validation for new lines and equipment for regulatory compliance (FDA/ISO 13485).
• Identify and mitigate manufacturing risks early in development; implement preventive actions.
• Drive continuous improvement of NPI processes to reduce costs and time-to-market.
• Coordinate supplier selection and qualification for new products.

Skills

DFM

DFA

Cross-functional

Process validation

SPC

SolidWorks

Creo

Lean manufacturing

Spanish

Project management

Education

Bachelor's degree

Master's degree

Tools

SolidWorks

Creo

Job description

About the Company

We are the people who give possibilities purposeBD 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.

Job Description

The Senior Engineer, New Product Introduction (NPI) will lead and drive the successful transition of new medical device products from design and development into commercial manufacturing.

This role ensures manufacturability, efficiency, and quality throughout the product lifecycle, acting as a critical bridge between R&D, Manufacturing, Supply Chain, and Quality teams.

Job Responsibilities

• Lead and manage all technical aspects of new product introduction, from concept through commercial launch, ensuring adherence to project timelines, budgets, and quality standards.
• Collaborate extensively with R&D, Manufacturing, Quality, and Supply Chain teams to define and optimize manufacturing processes, equipment, and workflows for new products.
• Participate in DFM/DFA (Design for Manufacturability/Assembly) reviews, providing feedback to design teams to optimize product designs for efficient and high-quality production.
• Develop and implement robust manufacturing strategies, including process flow, equipment selection, tooling design, and automation solutions.
• Oversee process validation activities (IQ, OQ, PQ) for new manufacturing lines and equipment, ensuring compliance with regulatory requirements (e.g., FDA, ISO 13485).
• Identify and mitigate potential manufacturing risks and issues early in the development cycle, implementing effective solutions and preventative measures.
• Drive continuous improvement initiatives for NPI processes, methodologies, and tools to enhance efficiency, reduce costs, and improve time-to-market.
• Coordinate supplier selection and qualification processes, collaborating with suppliers to ensure robust material and component supply for new products.

Job Qualifications

• Education: Bachelor's degree in engineering (Mechanical, Electromechanical, Biomedical, Industrial, or related field) required. Master's degree preferred.
• Minimum 4 years of experience in medical device manufacturing or manufacturing process development roles.
• Technical Skills: Demonstrated experience with Design for Manufacturability (DFM) and Design for Assembly (DFA) principles.
• Technical Skills: Strong understanding of manufacturing processes relevant to medical devices (e.g., injection molding, assembly, sterilization, packaging, automation).
• Technical Skills: Experience with process validation (IQ, OQ, PQ) and statistical process control (SPC).
• Technical Skills: Familiarity with CAD software (e.g., SolidWorks, Creo) and GD&T principles is a plus.
• Technical Skills: Knowledge of Six Sigma, Lean Manufacturing, and other continuous improvement methodologies.
• Communication: Proven ability to lead technical projects and cross-functional teams.
• Communication: Excellent written and verbal communication skills, with the ability to present technical information clearly and concisely to diverse audiences.
• Ability to speak Spanish is preferred.
• Strong problem-solving, analytical, and decision-making abilities.
• Ability to work effectively in a fast-paced, highly regulated environment.

Why Join Us?

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 healthcare. At BD, you'll discover a culture in which you can learn, grow and thrive. We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success. To learn more about BD visit https://bd.com/careers

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.

Primary Work LocationUSA CA - Irvine Laguna CanyonAdditional LocationsWork Shift

At BD, we reward, support and develop our associates through our comprehensive Total Rewards program. We are committed to attracting and retaining high quality talent by providing reward and recognition opportunities that promote a performance-based culture, as well as a competitive package of compensation and benefits programs. You can learn more on our career site under ' Our Commitment to You '.__Our salary or hourly rate ranges reward associates fairly and competitively. We regularly review these ranges and factors, such as location, contribute to the range displayed.Our pay is based on the role and the necessary skills and education to perform it successfully. The salary or hourly rate offered is determined by the role's specific requirements, including any applicable step rate pay system at the work location. Salary or hourly pay ranges are influenced by labor laws and Collective Bargaining Agreement (CBA) requirements applicable to the work location which may also affect the workplace arrangement of the role.

Salary Range Information $105,500.00 - $168,800.00 USD Annual