Packaging Engineer II

Becton Dickinson Medical Devices•San Diego, CA

5d•Onsite

About The Position

The R&D Packaging Engineer II plays a critical role in advancing healthcare and supporting the MDS business by leading the development, qualification, and commercialization of innovative packaging solutions for new and existing medical devices. This role combines technical expertise with a passion for innovation, driving projects from concept through launch. The engineer will apply engineering principles to develop and verify packaging systems, conduct root cause analyses, and recommend strategic solutions to technical challenges. With a hands-on approach and a collaborative mindset, the Packaging Engineer II contributes to product excellence and regulatory compliance. 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.

Requirements

Bachelor’s degree in Packaging Engineering, Mechanical Engineering, Biomedical Engineering, or a related technical field; advanced degree preferred.
Minimum of 1–4 years of experience in packaging engineering within the medical device or healthcare industry.
Proven track record in designing and developing packaging systems for sterile and non-sterile medical devices, including compliance with ISO 11607-1 & 2 and other relevant standards.
Demonstrated success collaborating with cross-functional projects involving new product development, sustaining engineering, and cost optimization initiatives.
Knowledge in Design for Six Sigma (DFSS), basic statistical analysis, and Design of Experiments (DOE) principles.
Proven ability to define and document packaging requirements for content sterile and sterile fluid path packaging systems for medical devices.
Knowledge designing different packaging system types for medical devices.
Skilled in verification and validation of packaging systems, ensuring compliance with regulatory standards.
Experienced in root cause analysis and failure investigations across diverse packaging designs; adept at leading defect management and Corrective and Preventive Actions (CAPAs).
Experienced developing PFMEA and DFMEA.
Knowledgeable of ISO 11607-1&2, ISO 13485, ISO 16975, and packaging- related ASTM or ISTA standards.
Experience conducting gap assessments, ensuring alignment with FDA, EU MDR or others global packaging compliance requirements.
Proficiency in SolidWorks
Experience developing packaging technical rationales and design verification by analysis
Understanding and application of core engineering principles, including first-principles analysis and calculations, to address packaging design challenges and development activities

Responsibilities

Lead the design, development, and qualification of packaging systems for sterile and sterile fluid path medical devices, ensuring compliance with ISO 11607-1 & 2 and applicable regulatory standards.
Owner of packaging specifications, responsible for the definition of all packaging system specifications.
Collaborates in the design control process for medium and high complexity projects.
Communicates data analysis including impact and recommended next steps to project/program leadership.
Collaborates on complex projects impacting design inputs/outputs and verification through testing and analysis from start to finish.
Ensures cross-functional strategies are clearly communicated and risks are appropriately managed.