The R&D Senior Packaging Engineersupports design, development, and validation of medical device packaging for several product platforms within BD Medical – Medication Delivery Solutions. 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.
Specific responsibilities will include the following as well as other duties as assigned:
Personal Leadership and Project Management
- Lead, coordinate, and support packaging projects to ensure compliance to specification, timeline, and schedule
- Demonstrate strong personal accountability for successful completion of designated tasks
- Provide project leadership to cross-functional teams comprising Manufacturing, Quality, Marketing, Medical Affairs, Regulatory Affairs, and others
- Act as Packaging subject matter expert on cross functional teams in order to drive Packaging strategy and alignment to best practices
- Proactively develop, maintain & share technical knowledge in specialized area(s), remaining up-to-date on current trends and best practices
Product and Packaging Design
- Understand 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
- Collaborate with Manufacturing and other functions across MDS to propose; assess the feasibility of; and implement packaging design, material, or process changes, including creative solutions to business or technical needs
- Assess manufacturability of new packaging designs, development of packaging processes, selection and justification of the appropriate capital equipment and changes to existing packaging designs and processes; Develop and execute packaging strategies for optimizing equipment usage and operational efficiency
- Support cost and supply continuity needs through continuous improvement, technology assessment, and innovation
- Support manufacturing sites in process validation, process capability issues, and customer issues.
- Develop and execute packaging test methods which can include specifying measurement equipment, test set-up, measurement systems analysis, and data analysis and align to business and regulatory requirements and needs
- Develop design verification traceability matrices and associated requirements analysis
- Write detailed technical reports based on design verification analysis/testing for design changes and product design activities
- Solve technical challenges drawing on a combination of experience, sound judgment, problem-solving skills, engineering first principles, and advanced engineering methods
- Comply with all local, state, federal, and BD safety regulations, policies, and procedures.
- Comply with all local BD quality policies, procedures, and practices through consistent application of sound quality assurance principles.
- B.S. degree in Packaging or associated field is required. Master’s degree in Packaging is preferred.
- Certified Packaging Professional through the Institute of Packaging Professionals is strongly preferred.
- 6+ years of Packaging experience is expected.
- 2-3 years of design for high volume regulated product manufacturing is expected. Medical device design experience is strongly preferred.
- Additionalexperienceto include:
- Demonstrated contributions to delivering robust products and packaging following a disciplined design process
- Medical device packaging system development for flexible and rigid medical device packaging applications
- Packaging system verification and validation experience
- Experience with statistics and design of experiments.
- Project management experience is preferred.
- Knowledge of the following standards: ISO 13485, ISO 11607, and ISO 14971.
- Knowledge and understanding of packaging test methods/standards and related test equipment pertaining to Medical Device Packaging.
- 4+years ofexperiencein package development including:
- Design of packaging for medical devices including familiarity with packaging materials and their limitations, and a demonstrated ability to translate internal and external customer needs into low cost and reliable package designs
- Experience with forming, sealing process and tooling design and development for form/fill/seal, flow-wrap, pouch solutions
- Experience with fabrication process to ensure manufacturability
Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of 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
Job ID R-322410