BD is a leading global medical technology company that develops, manufactures and sells medical devices, instrument systems and reagents. The Company is dedicated to improving people's health throughout the world.
BD is focused on improving drug delivery, enhancing the quality and speed of diagnosing infectious diseases and cancers, and advancing research, discovery and production of new drugs and vaccines. BD's capabilities are instrumental in combating many of the world's most pressing diseases.
Founded in 1897, BD employs approximately 45,000 associates in approximately 50 countries throughout the world. The Company serves healthcare institutions, life science researchers, clinical laboratories, the pharmaceutical industry and the general public.
The company headquarters in scenic Franklin Lakes, NJ is close to major metropolitan routes that provide easy access to numerous academic, arts, leisure, sports and historic areas of interest. BD offers a very competitive compensation and benefits package, strong leadership commitment to individual development and learning, and on-site fitness & wellness centers.
The Sr. Packaging Engineer will be a key contributor on a R&D team within BD-Life Sciences - Preanalytical Systems. The individual in this position will support design, development, verification and validation of medical device packaging for several product platforms.
The successful candidate will contribute to and/or lead a portfolio of packaging projects and ensure that best practices are employed and will have the opportunity to develop as an internal subject matter expert with respect to fundamental packaging materials and design.
They will share responsibility for teaching and training their peers; change management; and continuous improvement of our technical capabilities, including test method development and alignment to existing and evolving global standards.
- Act as Packaging subject matter expert on cross functional teams in order to drive Packaging strategy and alignment to best practices
- Demonstrates accountability for successful and timely completion of designated tasks.
- Provide project leadership to cross-functional teams comprising Manufacturing, Quality, Marketing, Medical Affairs, Regulatory Affairs, and others
- Proactively develop, maintain & share technical knowledge in specialized area(s), remaining up-to-date on current trends and best practices
- Demonstrates extensive knowledge of package Engineering principles and techniques.
- Understand internal/external customer needs through literature review, customer interviews, direct observation, competitive analysis, and/or prototype evaluation.
- Translate customer needs into engineering requirements leading to specific packaging, and process specifications.
- Design / Engineer robust and manufacturable packaging by drawing on a combination of experience, sound judgment, problem-solving skills, engineering first principles, advanced engineering methods and critical thinking.
- Independently determines and develops approach to solutions and presents results to peers and business leadership.
- Applies innovative & logical risk based approach to challenges with the capacity for original thinking.
- Support cost reduction and supply continuity needs through continuous improvement and technology assessment.
- Collaborate with Manufacturing and otherassociates across PAS to propose; assess the feasibility of; and implement packaging design/material/processes through rigorous Design Control processes
- Lead stability assessment on Packaging as well as all other Design Verification activities.
- Support manufacturing sites in process validation, process capability issues, and customer issues.
- Develop, write and execute robust packaging test methods, test fixtures, measurement systems analysis, protocols, data analysis and reports for Engineering studies, Design Verification, Validation, material and component specifications.
- Performs data analysis using statistical tools, regression analyses and appropriate technical rigor.
- Plans, executes and analyzes design of experiments (DOE).
- Comply with all local, state, federal, and BD safety regulations, policies, and procedures.
- Comply with BD quality policies, procedures, and practices through appropriate and consistent communication, training and education of sound quality assurance principles.
Bachelors/Masters in Packaging Engineering or related Engineering discipline.
B.S.: 8+ years of experience in Packaging or related area, specifically medical device and/or pharmaceutical experience.
M.S.: 5+ years of experience in Packaging or related area, specifically medical device and/or pharmaceutical experience.
- Medical device packaging system design and development for flexible and rigid packaging applications.
- Proficient in design & development of all levels of packaging with due consideration to safety, subsequent processing, environment & shipment logistics.
- Expertise with designing for high volume regulated manufacturing.
- Demonstrated contributions to delivering robust products and packaging following a disciplined design control process.
- Experience with forming/sealing process and tooling for hard and soft blister packs, web materials made of thermoplastics and reinforced paper, shrink wraps, flow wraps, automatic case carton erection, labeling (materials, adhesives, inks/printing, etc.), UDI compliance and barcode printing/decoding are all strongly preferred.
- Packaging system verification and validation experience.
- Experience with statistics and design of experiments (DOE).
- Experience in directing associates and leading small cross-functional groups.
- Strong project management, prioritizing and multi-tasking skills to work within tight deadlines.
- Knowledge and understanding of packaging test methods/standards and related test equipment pertaining to Medical Device Packaging.
- Must have thorough knowledge of the following standards: ISO 13485, ISO 11607, and ISO 14971.
- Understanding of Measurement Systems Analysis (MSA).
- Knowledge of Six Sigma (DMAIC) practices and Design for Six Sigma (DFSS) methodologies.
- Experience with R&D functional planning, requirement generation and technical (DFSS/Design/Cross functional) reviews.
- Sound knowledge of engineering first principles.
- Certified Packaging Professional through the Institute of Packaging Professionals is strongly preferred.
- Strong creative, analytical and problem solving skills required.
- Good written & verbal communication skills.
- Ability to effectively and clearly communicate concepts, ideas and knowledge to other individuals and teams.
- Software familiarity includes: Minitab, CAD (Creo, Solidworks, AutoCAD), TOPS (or similar pallet configuration tool), MS Office Tools, Applications & Packages (MS Word, Excel, PowerPoint, Outlook, etc.).
Job ID R-17289