- Utilize Six Sigma methodologies to identify potential manufacturing opportunities.
- Evaluate manufacturing processes that could be improved and developed a strategy for implementation.
- Provide leadership in the area of continuous improvement to significantly impact Cost Standards, Operations/Business System Efficiency and elimination of non-value added work.
- Draft, approve, execute, and maintain relevant documentation such as SOPs, specifications, drawings, process sheets, FMEAs, and facilitate validation protocols as necessary to support implementation of equipment projects, as well as new process integrations.
- Collaborate with team leadership in identifying risks and develop contingency plans (i.e. schedule slippage). Ensure that risk mitigation plans are implemented to achieve project timelines.
- Facilitate team decision-making, identify and escalate issues when appropriate. Manage and lead junior engineers on technical development and expertise.
- Perform other duties and responsibilities as assigned.
The ideal candidate requires a Bachelor's degree in engineering; mechanical or biomedical is preferred and a minimum 6 years of experience in the medical device industry OR a master's degree in engineering or materials in combination with 5 years of medical device experience. Expertise using ProE or SolidWorks is preferred.
- A minimum of 2 years of experience in leading scale-up and manufacturing implementation projects within an FDA regulated, manufacturing environment is required.
- Demonstrated use of process excellence methodologies, such as six sigma methodologies.
- Demonstrated use of Design for Manufacturability, Industrial Engineering and LEAN experience leading to manufacturing efficiency improvement.
- Knowledge of cGMP, EHS guidelines, FDA guidelines, Supplier Quality and Process Validation.
- Effective negotiation skills and ability to work through obstacles effectively.
- Capable of analyzing and solving complex problems in a fast pace environment through innovative thought and experience.
- Ability to develop process requirement specifications, collaborate with outside design firms and work with Operations personnel to establish efficient solution systems.
- Strong communication and interpersonal skills.
- Ability to work well independently as well as part of a team.