Associate Staff Packaging Engineer

Becton Dickinson Medical Devices•San Diego, CA

3d•Onsite

About The Position

The R&D Packaging Associate Staff Engineer supports the design, development, and implementation of medical device packaging solutions, including packages, processes, test methods, and equipment. The successful candidate will apply strong technical design, communication, and leadership skills to ensure compliance with applicable safety laws, quality policies, industry standards, and developed protocols, while contributing to innovative and sustainable packaging improvements that protect product integrity, improve cost, and help improve patient outcomes.

Requirements

A bachelor’s degree in STEM (Science, Technology, Engineering, Math), and six (6) years of engineering experience within the medical device or equivalent regulated industry.
Or a master's degree in STEM and four (4) years of engineering experience within the medical device or equivalent regulated industry.
Foundational engineering knowledge with the ability to apply sound technical judgment to medical device packaging design and testing activities under minimal guidance.
Solid understanding of disciplined product development and design control processes in a regulated environment.
Ability to support multiple projects simultaneously, including defining tasks, schedules, and work in collaboration with project teams and suppliers.
Experience contributing to the development, review, and execution of packaging test protocols, reports, and engineering documentation.
Problem‑solving skills with the ability to analyze data, identify issues, and recommend data‑driven solutions.
Proficiency with engineering and analytical tools such as SolidWorks, AutoCAD, and basic statistical analysis (e.g., Minitab).
Understanding of basic packaging materials, manufacturing processes, and test methods relevant to medical device packaging systems.
Strong written and verbal communication skills, with the ability to present technical information clearly to cross‑functional stakeholders.
Effective interpersonal skills and the ability to work collaboratively within cross‑functional teams.
Demonstrated ability to follow company procedures, quality system requirements, and applicable safety and regulatory standards.

Nice To Haves

Master’s degree in STEM with emphasis on package design & materials
Candidates that have packaging experience within the medical device or equivalent regulated industry.
Knowledge of medical device packaging standards and regulations, such as ISO 11607, ASTM D4169, and 21 CFR 820.30.
Familiarity with packaging material science and failure modes for common materials such as plastics, elastomers, and metals.
Experience or coursework in Design of Experiments (DOE), statistical methods, or advanced data analysis.
Exposure to manufacturing and assembly processes, including automated assembly, bonding techniques, and process validation concepts.
Experience supporting equipment or process qualification activities, including protocol execution and data analysis.
Awareness of sustainability principles and interest in developing environmentally responsible packaging solutions that support product usability and patient outcomes.
Demonstrated accountability, learning agility, and strong alignment with BD values and team‑oriented behaviors.

Responsibilities

Own the design, development, and qualification of packaging systems for sterile and sterile fluid path medical devices in compliance with ISO 11607‑1 & 2 and applicable regulatory requirements.
Contribute to packaging specifications, including definition, documentation, and maintenance of packaging system requirements.
Participate in design control activities for medium to high‑complexity projects, supporting design inputs, outputs, verification, and validation through testing and analysis.
Collaborate multi-functionally with R&D, Quality, Regulatory, Manufacturing, and suppliers to ensure packaging solutions meet performance, quality, safety, and sustainability objectives.
Develop and implement physical and functional package testing to ensure compliance with specifications and regulatory standards.
Author and support approval of test protocols, reports, specifications, and user documentation in accordance with company procedures.
Support equipment and process validation activities, including protocol review and execution support.
Assist with planning and coordination of engineering test builds and packaging evaluations.
Analyze packaging design, process, and test data; identify issues and supply to practical, data‑driven solutions.
Communicate technical information, test results, and analysis summaries to project and program team members, including identified risks and recommended actions.
Support complaint investigations and root cause analysis related to packaging, as assigned.
Ensure compliance with company procedures, quality system requirements, and applicable safety and regulatory standards.
Contribute to innovation initiatives, including sustainable packaging improvements that enhance product protection, usability, and patient outcomes.
Prepare and deliver written and oral technical updates to project teams and partners.
Mentor and provide technical guidance to junior engineers and team members.