Essential Functions (Responsibilities):

The Manufacturing Program Leader will provide Process Engineering and Project leadership to MFG.

Primary Responsibilities include:
Lead organization through New Product Introductions (NPIs).

- Partner with Design Engineering to ensure Production Preparation Process (3P), Design for Producibility (DFP), quality, safety, cycle time, etc. requirements are met.

- Define requirements for production capacity, initial acceptance quality, cycle time, manufacturing test equipment, and documentation.

- Lead manufacturing organization through process development, design transfer, prototype builds, training, generating manufacturing work instructions, troubleshooting, etc.

- Develop project plans and execute to meet plan and milestone targets

- Help develop new suppliers for new products

- Ensure all QMS Requirements, for manufacturing, are met during the program

Support Transfer and VCP projects between BJ site and other internal/external sites

- Work with global teams as either catching or pitching team leader

- Develop project plans for VCP programs and execute plans to ensure completion

Work with MFG Operations to simplify production lines, improve productivity and plan for future products to increase CM

This is a key technical cross functional leadership position, with interaction among engineering, manufacturing, sourcing, marketing, field service, and the supplier base that will drive cross-functional execution to exceed milestone and program targets for NPIs.

Perform other duties/projects as assigned

Qualifications/Requirements:

- Bachelor's degree in Engineering or Technical discipline.

- Excellent Project Management skills

- Ability to identify/track metrics and drive continuous improvement.

- Excellent interpersonal skills, ability to clearly communicate to internal/external customers and suppliers.

- Ability to lead and work with cross functional teams.

- Ability to interface with varied levels from Operators to Plant Management.

- Self-directed, highly detail oriented, organized, flexible and a strong team player.

- 3+ years of relevant experience in a manufacturing/engineering environment

Desired:

- Knowledge of FDA GMP processes and ISO 9001 manufacturing environment is a plus.

- Ability to thrive in a team environment with stringent regulatory requirements and high performance expectations.

- Ability to stay focused and motivated in a product focused, cross-functional team environment.

- Experience in a medical manufacturing environment

- Lean manufacturing experience

- Six Sigma experience/certification