Manufacturing Engineer, Life Sciences (130322448)
The Manufacturing Engineer will be on the Operation’s Engineering team supporting the Life Sciences business in Billerica MA. This position is primarily responsible for:
- New Product Introduction (NPI) using a phase gate approach while ensuring manufacturing readiness for transfer to pilot and manufacturing
- Production support for process of record (POR).
- Support continuous improvement projects for the manufacturing process and drive improvements to implementation.
- Serve as skilled expert for the product manufacturing and the application of critical problem-solving tools such as RCCA, Fishbone, IPO, FMEA, DOE etc.
- Lead equipment and process equipment installation, operation and performance qualification projects
- Transfer new products from engineering into pilot manufacturing and later into full scale manufacturing
- Manage commissioning, qualification, & validation (CQV) process as needed in compliance with industry guidelines
- Drive continuous improvement through automation, statistical methods and critical problem-solving tools
- Develop standard operating procedures, work instructions, test specifications and other process documentation
- Manage supplied equipment projects that may include design, build and test.
- Work with cross-functional teams to solve technical challenges that improve safety, quality, delivery, and cost.
- Ability to thrive in a fast-paced, collaborative, creative, results-driven, team-centric environment.
- Ability to lead and support cross functional teams and effectively communicate technical information
- Proficient with statistical and process improvement methodologies
- Dedication to achieving results and continuous improvement
- Bachelor’s Degree in Mechanical Engineering, Manufacturing Engineering or related engineering discipline.
- Minimum 5 years of manufacturing engineering experience, preferable in the life sciences or semiconductor industries.
- Demonstrated experience with equipment and process qualification and scale up.
- Experience and willingness to work in a cleanroom and biopharmaceutical environment is a plus
- Experience in SAP and SolidWorks preferred.
- Ability to perform job tasks, including lifting, using ladders, and climbing stairways