Senior Combination Product Technology Development-Device Engineer

Combination Product Technology Development / Device Engineer

This position reports to the Combination Product Technology Development Manager. As part of the BD / ZebraSci Combination Product Services team, the Combination Product Technology Development / Device Engineer will assist with technical and scientific activities related to combination product technology, test method development and execution, and technical contact for the ZebraSci Marketing / Operations team. This position performs technical analyses of drug delivery systems, designs fixturing, develops and validates test methods, and helps implement new testing technologies with minimal supervision. S / he will assist in planning, performing, and analyzing bench-level engineering tests or research experiments for drug-device combination products and medical devices. The position requires that the candidate develop and transfer various tests, including but not limited to Design Characterization, Design Verification, and Batch Release testing, to support operations.

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 usfrom design and engineering to the manufacturing and marketing of our billions of MedTech products per yearto 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.

Primary Duties, Responsibilities, and Authorities

• Supports in scoping testing approaches, fixture design, and data analysis.
• Authors test methods, test protocols, test method validations, and test reports with minimal supervision.
• Coordinates with the Technology Development team to discuss and resolve challenges with service projects.
• Supports technical initiatives related to combination products testing services, methodologies, and instrumentation.
• With minimal supervision, implements new equipment programs, tests, methods, instrumentation, and procedures.
• Plans and performs experiments that support new product or technology feasibility testing. Develops new methodologies or conducts routine procedures as needed.
• Interfaces with machine shop to execute fixturing development and fabrication to support experimental designs and performs testing of the product experimentally as required.
• Conducts testing as assigned utilizing appropriate test methods, protocols specifications and equipment (includes product and / or equipment testing).
• Keeps a working knowledge of commonly prescribed methods, background information, and troubleshooting strategies, including cGMPs and relevant ISO and ASTM guidelines.
• Adheres to ZebraSci Quality Systems, including but not limited to, timely identification and notification of potential Quality Events (e.g., OOS, Deviations, CAPA) and the subsequent forward processing and investigation of such events.
• Follows established Standard Operating Procedures, makes recommendations for edits, enhancements, and / or new procedures.
• Assist with edits, review, issuance, and archiving of quality system documents as needed
• Effectively communicates orally and in written project progress and results within the Technology Development and Operations Team.
• Skilled in effectively presenting and communicating performance results and test outcomes
• Communicates challenges, scheduling or testing conflicts, and other issues to management in a timely manner
• Provides guidance to lab staff when needed
• Understands documentation requirements per cGMP
• Able to troubleshoot and provide technical assistance for Root Cause Investigations
• Assists staff, including activity training and oversight when needed
• Works and communicates openly and collaboratively with colleagues and staff.
• Responsible for maintaining the lab and storage areas in a clean and organized manner.
• Demonstrates project planning and organization skills to balance a multitude of projects simultaneously.
• Supports the Services Technology Development Management, as needed.
• Support other activities and duties as needed or assigned.

Minimum Requirements :

Preferred Qualifications :

Primary Work Location and Additional Considerations :

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.

For certain roles at BD, employment is contingent upon the Company's receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and / or required. Consistent with BD's Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.

Why Join Us?

A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It's also a place where we help each other be great, we do what's right, we hold each other accountable, and learn and improve every day.

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 health. At BD, you'll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place.

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.

Required Skills

Optional Skills

Primary Work Location : USA CA Temecula

Additional Locations

Work Shift

At BD, we are strongly committed to investing in our associatestheir well-being and development, and in providing rewards and recognition opportunities that promote a performance-based culture. We demonstrate this commitment by offering a valuable, competitive package of compensation and benefits programs which you can learn more about on our Careers Site under Our Commitment to You.

Salary or hourly rate ranges have been implemented to reward associates fairly and competitively, as well as to support recognition of