Senior Process Development Engineer

Summary

Join Sword Health, a Forbes Best Startup Employer, and become our Process Development Engineering Manager. Lead a remote team supporting global manufacturing operations, overseeing development, qualification, and continuous improvement. You will manage overseas manufacturing, design and optimize processes, maintain metrics, and ensure regulatory compliance. This role requires a degree in engineering, 8+ years of relevant experience, and proven management skills. Sword Health offers a stimulating environment, career development, competitive salary, flexible hours, unlimited vacation, and various benefits including health insurance, equity shares, and parental leave.

Requirements

• Degree in Mechanical, Manufacturing, or Industrial Engineering or related field
• 8+ years of experience in manufacturing or industrial engineering for medical devices or within a regulated industry
• Prior experience managing a remote 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)

Responsibilities

• Oversee a remote team of process development engineers and technicians in Salt Lake City (USA) and Canelas (Portugal)
• Maintain manufacturing oversight of overseas manufacturing operations in SE Asia
• Design, develop, optimize, and scale up manufacturing processes for new and existing products
• Maintain and refine SPC manufacturing metrics
• Oversee maintenance on Sword-controlled Production Assets (scheduled and unscheduled)
• Support engineering teams to define, develop, and launch production lines in support of existing and new products
• 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
• 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