This role focuses on supporting and advancing manufacturing processes within a regulated production environment. It combines process development, problem-solving, and cross-functional collaboration to ensure product quality, efficiency, and compliance.
You will work independently while partnering with engineering, operations, and quality teams to implement improvements, support product launches, and maintain manufacturing standards.
What you will do
- Lead development, implementation, and improvement of manufacturing processes to meet product specifications and quality standards
- Design and optimize production methods, tooling, and process controls to improve efficiency and performance
- Conduct verification and validation activities, including process validation, packaging validation, and shelf-life studies
- Analyze production data and implement process improvements using structured problem-solving methodologies (e.g., continuous improvement frameworks)
- Investigate and resolve production issues to minimize downtime and ensure consistent output
- Support new product introductions and process transfers into manufacturing operations
- Collaborate with cross-functional teams on product development and manufacturing readiness
- Train employees on manufacturing processes, procedures, and equipment
What you will need
Required
- Bachelor’s degree in Engineering or related technical field
- Minimum 5 years of experience in medical device manufacturing
- Minimum 1 year of experience supporting manufacturing process transfers
- Experience working with regulated environments (e.g., ISO standards and regulatory requirements)
Preferred
- Experience with process validation, equipment qualification, and manufacturing scale-up
- Experience using engineering or statistical tools (e.g., design software, data analysis tools)
- Experience working on new product introduction within manufacturing environments
