Job ID R-304206
Job Description Summary
Product Engineering is responsible for developing iterations, modifying, scaling up, commercializing, and supporting existing BD products and product families through adherence to established quality, design control processes and good engineering practices.
What is expected of you for success in your role?
- Ability to work with little supervision on high-impact projects
- Ability to verify work product to minimize errors and ensure compliance to the BD Quality system
- Apply knowledge of general engineering principles, materials, DFMA and reliability to achieve product requirements.
- Work with upstream R&D, Marketing, Quality and Manufacturing stakeholders to identify manufacturing, material and/or product improvement opportunities and provide innovative product, system and component solutions.
- Perform detailed design and process analysis and provide input or approval for detailed component and equipment specifications.
- Analysis of new manufacturing processes to identify opportunities to improve for implementation within the timelines laid out for the overall project
- Coordinate scale up commercialization of new products and/or processes with manufacturing sites
- Assist in developing and monitoring project plan, budget, contingency plans and work estimation.
- Coordinate integration of complex sub-system product designs into manufacturing processes.
- Provide technical leadership to product development teams in cost savings, sustaining, or design transfer activities.
- May mentor junior associates as required.
- Otherresponsibilities may be assigned and not all responsibilities listed may be assigned.
- BS or MSengineeringdegree (preferably Mechanical or Biomechanical Engineering)
- 5-7+ years of product engineering and design transfer-related experiencerequired in medical device or pharmaceutical industry working in a team base environment.
- Knowledge of general design engineering and DFMA principles, component manufacturing processes, tooling methodologies, material properties required.
- Experience with CAD / CAM and design analysis software, and statistical analysis techniques required.
- This role will also require outstanding leadership capabilities with the innate talent to work in a cross-functional team environment.
- Working knowledge and understanding of global medical device and pharmaceutical regulatory requirements.
- Technical writing: protocols, testing results, procedures, status and special reports.
- Project management and Leadership skills
- Knowledge and understanding of ISO (International Organization for Standardization) and GMP (Good Manufacturing Practices).
- Information and risk analysis skills
- Quality, statistical process controls
- Knowledge of part manufacturing processes and tooling methodologies.
- Effective team interpersonal skills
- Ability to communicate effectively through multiple modes in order to address project needs
- Conflict analysis and resolution
- Consulting, design review, and constructive feedback
- Negotiating (e.g., internal and external customers), Networking
- Able to adapt to shifting priorities and work adeptly in a fast- paced environment.
- Able to take initiative and be self-managed.
- Prior experience participating in process efficiency improvement technology transfer into base business, or cost reduction projects is highly desired.
- Process Excellence training or certification would be highly desired (Six Sigma or Lean Green or Black Belt).
- Knowledge of statistical tools such as ANOVA, DOE, or Hypothesis Testing Tools would be a preference.
- All candidates must possess excellent verbal and written communication skills, strong decision making and problem solving skills and outstanding interpersonal relationship and people skills.
- The ability to function as a team player and work in a matrix, cross functional organization is a must.
- (MECHANICAL): Free-body and stress-strain analysis and FEA (finite element analysis), Geometric tolerance and tolerance stack-up analysis (GD&T). Gauge repeatability and recalibration system and methodology, Plastic resins, adhesives, sealants and nonwoven materials.
ADDITIONAL PREFERRED EXPERIENCE / COMPETENCIES:
- Demonstrated capability in customer interaction and translation of customer needs into design requirements.
- Practical, hands-on approach to problem solving.
- Demonstrated track record of cross functional collaboration and team work.
- Comfortable with ambiguity and able to make progress in the face of uncertainty. Able to discern the most important questions to be addressed and identify a path to answer them fully in a compliant manner.
- Ability to approach challenges with an attitude of "How do we make this happen?”
- Experience in non-woven converting, unwinding, spreading, folding, dispensing, filling, and cutting operations.
- Experience using converting equipment such as Flow-wrapper, Clipper, inline Metal Detectors.
- Experience in specifying utilities and overseeing installation of equipment as well as equipment qualification.
- Experience working in a medical device or pharmaceutical manufacturing environment.
- 10% to 15% Travel may be required.