Process Development Engineer

For services in the validation and manufacturing process. 

WHAT MAKES YOU A FIT: 

The Technical Part:

• Engineering Degree. Experience. 1-8 years of related experience Manufacturing background Medical Device industry experience.
• Experience in:
  • Process development projects from conception to implementation, ensuring project deadlines and objectives are met.
  • Familiarity with a variety of technologies and equipment used in the industry to carry out manufacturing processes, such as Laser Welding, Stringing, Staking, Heat Bonding, Injection Molding, Vision Systems, general experience with automated equipment (PLC/Servos/Pneumatics/ Sensors), etc.
  • Experience with design of experiments (DOE) to characterize and optimize processes, as well as analyze the resulting data to draw meaningful conclusions.
  • Ability to identify areas of improvement in processes and develop strategies to optimize the efficiency, quality and/or yield of those processes that are being developed

The Personality Part: 

• If you feel a passion for transforming lives and innovating with new medical solutions, using global collaboration, high performance, diversity and winning spirit, then this is a job for you.

AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job)

• Support process and/or equipment validation activities (IQ, OQ, PQ); process performance qualification activities and develop Master validation plans for new processes or products.
• 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 on statistical sampling plans, and other development procedures.
• Design and develop in-process and receiving quality systems for new processes and components
• Generate equipment documentation, such as equipment entries, evaluations, PM and calibration procedures, as required.
• Define gages, tools and equipment for the test methods developed.
• Generate manufacturing instructions for new processes being developed
• Work cross-functionally with other departments to accomplish PD tasks.

WHO WE ARE:

We are a Service Provider company different from the rest. We pride ourselves in how we treat the most important piece of our company's puzzle: you! We integrate Engineering, Construction, Maintenance, Utilities and Specialized Technical services across the Island (and in the US as well!). Our company is flexible, family-oriented and focused on our resources' well-being, while providing our Pharmaceutical, Medical Device and Manufacturing industry clients with top-notch quality talent. We're FITS! 

Are you the next piece?