BD: Process Development Engineer

Job Description SummaryJob DescriptionDescription:The Senior Process Development Engineer executes specific and general assignments / projects that provide innovative, functional and cost-effective solutions to support product development and commercialization in a team based environment.

The Senior Engineer is responsible for ensuring that products are designed for manufacturing and that robust processes are in place to scale up manufacturing for commercialization.

In addition, the Senior Engineer will support existing BD products and product families through adherence to established quality, design control processes and good engineering practices.

Additional Responsibilities: Ability to verify work product to minimize errors and ensure compliance to the BD Quality system.Ability to lead high impact projects with little supervision.Apply knowledge of general engineering principles, materials, design for manufacturing, DFMEA, PFMEA and process reliability to achieve product design 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 commercialization of new products and/or processes with manufacturing sites.Assist in developing and monitoring project plan, budget, contingency plans and work estimation.Provide technical leadership to product development teams in cost savings, sustaining, or design transfer activities.Coordinate integration of complex sub-system product designs into manufacturing processes.May mentor junior associates as required.Other responsibilities may be assigned and not all responsibilities listed may be assigned.

Required Competencies:Education: BS or MS engineering degree (preferably Mechanical, Chemical or Biomechanical Engineering).Skills 8+ years of product engineering and design transfer-related experience required in medical device or pharmaceutical industry working in a team based environment.Additional required skills:Outstanding leadership capabilities with the innate talent to work in a cross-functional team environment.Project management and Leadership skills.Information and risk analysis skills.Ability to communicate effectively through multiple modes in order to address project needs.Effective team interpersonal skills.Must possess excellent verbal and written communication skills, strong decision making and problem-solving skills and outstanding interpersonal relationship and people skills.Able to adapt to shifting priorities and work in a fast-paced environment.Able to take initiative and be self-managed.Practical, hands-on approach to problem solving.Experience Experience leading process development in the medical device and/or pharmaceutical industry required with an emphasis on moving from pilot to commercial scale production within a medical/pharma Quality system.This role will also require outstanding leadership capabilities with the innate talent to work in a cross-functional team environment as a subject matter expertPreference for individuals that have experience with a diverse portfolio while directly managing engineering associatesProject management and/or program management experience is also required.Experience with statistical analysis techniques and technical writing (beyond templated IQ/OQ/PQ documents).Experience with design for manufacturing highly desired.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 (ex.

Six Sigma, Lean Green or Black Belt).Demonstrated capability in translating customer needs into design requirements.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.Experience in quality, statistical process control, and conflict analysis & resolution.Knowledge and understanding of ISO (International Organization for Standardization) and GMP (Good Manufacturing Practices).PRIMARY LOCATION: North America United States-Illinois-Vernon HillsJOB FUNCTION: Product Engineering Primary Work LocationUSA IL Vernon HillsAdditional LocationsWork ShiftNA (United States of America)