Applies knowledge of technical principles and our client's systems/procedures to optimize manufacturing processes.
Identify and ensure implementation of opportunities to optimize/improve manufacturing processes including using engineering methods (e.g., SIX Sigma and LEAN methods) employing technical design skills to re-design/design of and ensure equipment, tools, fixtures, etc are up to standards. Develop complex experiments and tests (including writing and executing protocols) to qualify and validate manufacturing processes; analyze results, make recommendations, and develop reports. Analyze and resolve complex Manufacturing and Compliance issues (e.g., CAPA, non-conformances,
Develop training and documentation materials (e.g., work instructions) for production to enable the seamless knowledge transfer of project and manufacturing processes. Lead and establish project plans to ensure deliverables are completed to customer’s expectations, using project management tools (e.g., Project Plan, Risk Analysis, etc.). Oversee manufacturing support tasks; give instruction to technicians on conducting tests; train technicians and provide feedback; and coordinate technician work. Train, coach, and guide lower level employees on routine procedures.
Proven expertise in usage of MS Office Suite including MS Project; CAD experience preferred (if applicable). Strong documentation, communication (e.g., written and verbal) and interpersonal relationship skills including consultative and relationship management skills. Basic (UT: Good) understanding of statistical techniques. Previous experience working with lab/industrial equipment required.
Substantial understanding and knowledge of principles, theories, and concepts relevant to Engineering. Strong problem-solving, organizational, analytical and critical thinking skills. Substantial understanding of processes and equipment used in assigned work. Good leadership skills and ability to influence change. Knowledge of and adherence to Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing.
Work is performed independently and reviewed upon completion for adequacy in meeting key objectives. Participates in determining objectives of assignment; plans schedule and arranges own activities in accomplishing objectives. Contributes to the completion of significant organizational projects and goals; Input on overall objectives and long-range goals of the organization is given serious consideration. Must be able to work in a team environment, including inter-departmental teams and key contact representing the organization on contracts or projects. Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations. Develops solutions to a variety of complex problems. Identifies opportunities for process improvements.
Bachelor’s Degree in Engineering or Scientific field with four (4) years of industry/education related experience; or Master’s Degree or equivalent in Engineering or Scientific field with three (3) years of industry/education related experience; or Ph.D. or equivalent in Engineering or Scientific field with no experience