Process Development Engineer
Flexible & Integrated Technical Services
- Dorado, PR
- Permanente
- Tiempo completo
- Bachelor Degree in Engineering and three (3) years of experience in the medical devices industry.
- Bilingual: English and Spanish
- Skills: Writing Skills
- Shift: Administrative, and according to business needs.
- Experience in:
- Process and/or equipment validation activities (IQ, OQ, PQ).
- Responsible for reviewing and developing process validation protocols and reports.
- Automation systems testing.
- Process Development and/or Manufacturing Process Engineering.
- Support process and/or equipment validation activities (IQ, OQ, PQ); process performance qualification activities, and develop Master validation plans.
- Responsible for reviewing and developing process validation protocols and reports. Support other functional areas during the validation activities.
- Work with the Process Development team to efficiently qualify new processes; assist with statistical sampling plans, and other development procedures.
- Be able to manage process development projects from conception to implementation, ensuring project deadlines and objectives are met.
- Familiarity with a variety of technologies and equipment, such as Laser Welding, Stringing, Staking, Heat Bonding, Injection Molding, Vision Systems, and general experience with automated equipment.
- Experience with the design of experiments (DOE) to characterize and optimize processes.
- Ability to identify areas of improvement in processes and develop strategies to optimize the efficiency, quality, and/or yield of those processes.
- Assures that appropriate resources (personnel, tools, etc.) are maintained to assure Quality System compliance and adherence to the Quality Policy.
- Establishes and promotes a work environment that supports the Quality Policy and Quality System.