Senior Engineer, Product Development Engineering

RXinsider LTD.; Irvine (CA); On-site; USD 106,000 - 169,000; Full time

Job summary

BD in Irvine is seeking a Senior Engineer, New Product Introduction, to lead the transition of new medical device products from design to commercial manufacturing. You will ensure manufacturability, quality, and regulatory compliance while serving as a bridge between R&D, Manufacturing, Quality, and Supply Chain.

You will drive DFx, process validation (IQ/OQ/PQ), risk mitigation, supplier qualification, and continuous improvement across NPI, with opportunities to influence design through

Qualifications

• Bachelor's degree in engineering required; Master's preferred.
• Minimum 4 years in medical device manufacturing or process development.

Responsibilities

• Lead NPI from concept to commercial launch with timelines, budgets and quality.
• Collaborate with R&D, Manufacturing, Quality and Supply Chain to optimize processes.
• Participate in DFM/DFA reviews to improve designs for manufacturability.
• Develop manufacturing strategies, tooling design, and automation solutions.
• Oversee IQ/OQ/PQ validation for new lines and equipment with regulatory compliance.
• Identify and mitigate manufacturing risks early and implement preventive measures.
• Drive continuous improvement and supplier qualification for new products.

Skills

DFM & DFA

Manufacturing processes

SPC

CAD (SolidWorks/Creo)

GD&T

Six Sigma / Lean

Cross-functional leadership

Education

Bachelor's degree in engineering

Master's degree preferred

Tools

SolidWorks

Creo

SPC tools

Job description

We Are The People Who Give Possibilities Purpose

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.

Job Description

Job Summary

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

• 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.
• Strong understanding of manufacturing processes relevant to medical devices (e.g., injection molding, assembly, sterilization, packaging, automation).
• Experience with process validation (IQ, OQ, PQ) and statistical process control (SPC).
• Familiarity with CAD software (e.g., SolidWorks, Creo) and GD&T principles is a plus.
• Knowledge of Six Sigma, Lean Manufacturing, and other continuous improvement methodologies.

Communication

• Proven ability to lead technical projects and cross-functional teams.
• 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 Location

USA CA - Irvine Laguna Canyon

Salary Range Information

$105,500.00 - $168,800.00 USD Annual