The Director of Manufacturing Service serves as a member of the Operations leadership team, overseeing the manufacturing and improvement of a family of novel vascular access medical devices.
The Director will perform all aspects required for hands-on planning and execution of quality enhancement, capacity expansion, costs and performance improvements in an entrepreneurial organization with a ZERO Backorder Policy.
The ideal candidate is a subject matter expert in mechanical engineering with a specific concentration on novel, high volume medical devices.
Success in this role entails:
- Provide leadership in a team of highly motivated, world class Team of professionals
- Create a culture of manufacturing excellence in a fast-paced, lean environment
- Work with R&D to generate and refine product specifications
- Generate required documentation including timelines, budgets, specifications, testing protocols, and failure analysis
- Deliver programs on time, on budget that provide sustainable competitive advantage.
- Own the Manufacturing Quality Improvement Plan assure complete compliance with all requirements
- Prepare documentation for the internal quality system
- Develop/coordinate efficient manufacturing processes with third party contract manufacturers
- Develop specifications and quality standards system to comply with industry standards
- Coordinate and manage cost improvements
- Collaborate on automated robotic machine design with vison systems
- Develop new manufacturing processes to increase productivity
- Evaluate new technologies for addition to the company’s portfolio
- Plan production requirements and assure on time delivery of product
- Negotiate with suppliers and develop strong partnerships
This position requires a passion for customer service, high quality product performance, technology innovation, and process excellence, as well as a proven track record in high volume manufacturing with automation.
- Strong project management experience – overseeing budgets and timelines,
- Demonstrated ability to deliver on time, on budget in a fast paced lean company
- Creative thinker
- Experience with high volume novel hospital supply products (e.g., phlebotomy needles, peripheral IV catheters, extension sets)
- Entrepreneurial and hands-on mind-set
- 15+ years of experience in medical products manufacturing environment.
- Bachelors of Science in Mechanical Engineering or Masters of Science in Mechanical Engineering and fifteen+ years of experience.
U.S. Permanent Work Authorization Required