Description
Position Description
Responsible for operating as the co-Program Director, partnering with an external design and manufacturing firm for the turn-key development of medical products. This requires significant breadth of knowledge and understanding the broad range of disciplines required to bring products to market. The role will be the main contact point for third party turn-key product development. This individual will have indirect people management responsibilities and will also have management responsibilities for project budgets.
Position Responsibilities
Role functions as the main liaison between Physio-Control and our external product developer.
Responsible for the oversight of requirements, plans and schedules for the development of a medical product.
Scheduling, managing and controlling robust design reviews.
Collaborates with other functional groups to define the product content/feature set and system requirements; partners with Strategic Sourcing, Purchasing, Supplier Quality, and other vendor-focused internal functions.
Manages feasibility studies on technical/marketing proposals and related data for designing new products.
Responsible for ensuring appropriate level of product testing and documentation throughout all phases of development.
Manages appropriate levels of interface with Regulatory Affairs, Clinical, Quality, Marketing, Manufacturing and outside customers and suppliers throughout the development cycle to ensure readiness for product release.
Perform other related duties as assigned.
Requirements
Basic Qualifications
Bachelor’s degree in an engineering discipline
Ten years experience leading complex development projects in an engineering environment
Experience in a highly regulated medical environment
Experience managing external contract firms
Excellent communication skills with both external and internal audience
Solid business and technical acumen
Desired/Preferred Qualifications
Certification in Project/Program Management
International product development experience
Physical Job Requirements
Moderate travel (10-20%) may be required