Pain Management Process Development Lead
Há 7 horas
About the Role
Sword Health, Inc is revolutionizing pain management through innovative technology solutions. As a Pain Management Process Development Lead, you will play a critical role in developing and optimizing manufacturing processes to ensure high-quality products that alleviate suffering worldwide.
Job Summary
This senior leadership position oversees a remote team of process development engineers and technicians, driving the qualification, maintenance, and continuous improvement of global manufacturing operations. You will maintain oversight of overseas manufacturing operations in Southeast Asia, design and develop manufacturing processes for new and existing products, and ensure compliance with regulatory requirements.
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.
Requirements
To succeed in this role, you will need:
- 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)
Benefits
We offer a competitive salary of $120,000 - $180,000 per year, depending on experience, plus a comprehensive benefits package, including health insurance, retirement plan, and generous PTO policy. We also offer access to professional development opportunities and a dynamic, fast-paced work environment that fosters creativity and growth.
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