Senior Process Development Engineer

Degree in Mechanical, Manufacturing, or Industrial Engineering or related field
6+ years of experience in manufacturing or industrial engineering for medical devices or within a regulated industry
Prior experience managing a smaller team
Highly independent and self-directed
Ability to work with our remote teams in SLC, NY, and Porto
Excellent verbal and written communication skills
Excellent organizational skills and attention to detail
Time management skills with a proven ability to meet deadlines
Strong analytical and problem-solving skills, including Statistical Analysis of data
Ability to prioritize tasks and to delegate them when appropriate
Ability to function well in a high-paced and at times stressful environment
Proficient in English and Spanish (to easily converse with production specialists and operators)

Design, develop, optimize, and scale up manufacturing processes for new and existing products
Running tests directed by Process Development Engineering Manager
Oversee troubleshooting of Production equipment issues (such as production test equipment, production computers, label printers, etc.)
Updating equipment with new components and/or features
Maintenance on Production equipment (scheduled and unscheduled)
Implementation of new supplies or equipment for production line
Work with Production & Quality teams on develop and maintain process documentation, such as standard operating procedures, work instructions, and process flow diagrams
Conduct Installation, Operational, and Performance Qualifications (IQ/OQ/PQ)
Development and execution of protocols and filling out reports
Production Line Manufacturing Metrics tracking tools setup and analysis (SPC)
Management of calibration of tools
Ensure compliance with regulatory requirements, including FDA, ISO etc. Periodically supports periodic facility and workforce compliance audits.

No preferred qualifications provided.