Description:
The Staff Engineer will lead high level engineering efforts to develop and improve products, manufacturing processes, equipment and systems by application of high-level engineering skills, structured experimentation and process optimization techniques. This role will provide engineering leadership in terms of long-term technology development and will lead the alignment of our capabilities with the existing and future user needs of our customers.
Principal Responsibilities
- Coach, develop, manage and motivate staff to ensure that employees achieve their full potential.
- In conjunction with the Engineering Manager, develop and cascade departmental long term and short term business objectives, in line with business needs.
- This role will principally focus on further developing our fluoropolymer extrusion capability and deepening our understanding of this process.
- Take a hands-on approach to process improvement based on a deep understanding of the existing process tacit knowledge. Use of structured experimentation techniques and process optimization techniques to deepen the site’s process understanding and provide a solid engineering framework to manage and refine these processes in the long term.
- Apply six sigma principles, lean thinking, and continuous improvement tools where they are appropriate to improve process performance.
- Lead and oversee major projects in a matrix organization as a team leader, whose duty encompasses the full scope of the project
- Independently plan and technically lead a program of projects utilizing project plans and schedules to track and communicate developments from prototype stage to volume production.
- Support successful new product development by developing fully characterizing and implementing strong robust manufacturing processes.
- Communicate and liaise directly with customers during the development stage of development projects in line with site requirements
- Drive refinement and updating of process PFMEA’s in order to better capture and record the site’s tacit knowledge in relation to core manufacturing processes.
- Develop systems which efficiently leverage existing process characterizations and validations knowledge for new product introductions.
- Develop systems to demonstrate and achieve equipment equivalency on all core processes so process validations can be leveraged across the equipment stock.
- Develop active plant wide map of equipment that is equivalent for validation purposes.
- Identify opportunities and implement changes to reduce variation and improve scrap rates and productivity often through the implementation of new technology or more refined process controls.
- Stay current with cutting-edge medical device industry and technology trends to help ensure the site is constantly evolving to better meet customer needs.
- Take total ownership for area of responsibility. This can be interpreted as taking a proactive approach to improvement and anticipating, recognizing, and dealing with problems before they become major issues.
- Direct and mentor the efforts of engineers, engineering specialists and engineering technicians in the development of products, processes, specification of equipment and creation of documentation to support process development, characterizing and qualification.
- Generate and evaluate alternatives, analyze data, reach logical conclusions, formulate recommendations, and institute effective changes.
- Execute and complete improvement projects that improve quality, increase capacity, reduce scrap, or reduce cost
- Lead process improvement with emphasis on the fluoropolymer extrusion processes with the goal of driving long term sales growth.
- Ensure full compliance with regulatory requirements.
- Ensure Quality and EHS policies and procedures are adhered to at all times.
Education / Experience Requirements
- Bachelor's level degree in Engineering or equivalent with deep experience in process development, optimization, and refinement.
- MS degree in an engineering field preferred.
- Fifteen (15) or more years of relevant experience in engineering field related to manufacturing in a medical device environment.
- Prior experience with extrusion processes a distinct advantage
- Proficient in Microsoft Office Suite and computerized analysis applications.