Senior Process Development Engineer

What you will be doing:

• 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.

What you need to have:

• 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).

To ensure you feel good solving a big Human problem, we offer:

• 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.