Senior Process Development Engineer

Summary

Join Sword Health, a Forbes Best Startup Employer, and contribute to our mission of freeing billions from pain. As a Sr. Process Development Engineer, you will play a key role in developing and maintaining our production processes. This position requires a strong engineering background, experience in medical device manufacturing, and excellent communication and problem-solving skills. We offer a stimulating, fast-paced environment, career development opportunities, competitive salary, flexible work arrangements, and comprehensive benefits. This role is based in Portugal and requires a valid EU visa; relocation assistance is not provided.

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)
• Possess a valid EU visa and be based in Portugal

Responsibilities

• Design, develop, optimize, and scale up manufacturing processes for new and existing products
• Run tests directed by Process Development Engineering Manager
• Oversee troubleshooting of Production equipment issues (such as production test equipment, production computers, label printers, etc.)
• Update equipment with new components and/or features
• Perform Maintenance on Production equipment (scheduled and unscheduled)
• Implement 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)
• Develop and execution of protocols and filling out reports
• Setup and analysis of Production Line Manufacturing Metrics tracking tools (SPC)
• Manage calibration of tools
• Ensure compliance with regulatory requirements, including FDA, ISO etc. Periodically supports periodic facility and workforce compliance audits

Benefits

• A stimulating, fast-paced environment with lots of room for creativity
• A bright future at a promising high-tech startup company
• Career development and growth, with a competitive salary
• The opportunity to work with a talented team and to add real value to an innovative solution with the potential to change the future of healthcare
• A stimulating environment with room for creativity
• A flexible environment where you can control your hours (remotely) with unlimited vacation
• Access to our health and well-being program (digital therapist sessions)
• Remote or Hybrid work policy
• 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