Job Summary: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.
Job Responsibilities: (Primary Duties, Roles, and/or Authorities)- 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.
Minimum Qualifications:- 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.
Preferred Qualifications:- Master's degree in STEM with emphasis on package design & materials
- Candidates that have packaging experience within the medical device or equivalent regulated industry.
Essential Knowledge and Qualification Skills:- 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.
- Desired Knowledge and Qualification Skills:
- 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.
Physical Demands:This position is in an office and laboratory environment and requires the incumbent to sit, stand and perform general office functions. The incumbent may also be required to lift up to twenty-five pounds occasionally. The incumbent may be required to stand for extended periods. Bending, stooping, and reaching are also frequently required.
Work Environment: - Onsite in office environment.
At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.
Primary Work LocationUSA CA - San Diego TC Bldg C&D
Additional LocationsWork ShiftNA (United States of America)
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$124,700.00 - $205,800.00 USD Annual
