Senior Process Development Engineer

2 days ago

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Sword Health

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Digital Health • medical devices • machine learning • Artificial Intelligence • physical therapy

201 - 500 employees

Founded 2015

⚕️ Healthcare Insurance

🤖 Artificial Intelligence

🧘 Wellness

Description

• The Sr Process Development Engineer role is primarily responsible for the support in developing and maintaining production. • 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.

Requirements

• 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).

Benefits

• Comprehensive health, dental and vision insurance* • Equity shares* • Discretionary PTO plan* • Parental leave* • 401(k) • Flexible working hours • Remote-first company • Paid company holidays • Free digital therapist for you and your family