The Opportunity
The Director of Engineering works within the Global Operations Engineering function and is responsible for creating innovative engineering process design and design for manufacturability of medical products in a highly regulated environment. This individual creates and maintains an efficient, highly motivated technical development organization. The role is key to accelerating growth through decreased time to market for new products and processes, specifically the time to develop new equipment and tooling.
Key Responsibilities
1. Functional management of process development engineering disciplines in a controlled environment.
2. Engineering budgeting including long-range capital planning for new processes and tooling.
3. Evaluating and identifying suppliers for process automation and tooling.
4. Assessing new technologies and developing roadmaps.
5. Career development of direct reports.
6. Communicating group status to senior staff.
7. Establishing company-wide policies and procedures for design for manufacture.
8. Partnering with R&D to optimize manufacturing input at the earliest stage of development.
9. Maintaining Quality System compliance across teams.
Requirements
1. Bachelor's Degree in Engineering or equivalent combination of education and work experience.
2. At least 12 years of experience in product/process development roles.
Preferred Qualifications
1. Master's Degree.
2. Experience in medical device development.
3. Demonstrated knowledge of regulations for medical device development (ISO13485, FDA QSR) or substantial experience in product development for quality-sensitive applications.