11720 North Creek Parkway N new 7/22/15 Bothell, WA 98011
Position Title: Project Manager
Position Description: Our client in Bothell, WA has an exciting opportunity for an experienced Program Manager. Candidates must have several years of product development experience in a regulated environment.
- Bachelor degree in Engineering or equivalent experience. Master’ s degree is highly desirable.
- Minimum of 5 years of product development experience specialized in medical equipment or capital equipment with complex electronics.
- Experience in developing products in a regulated environment (e.g., medical or Aerospace and IEC 60601-1 or RTCA-DO-160, ISO 13485, 14971 and 10987) is required.
- Strong understanding of project/program management is required with an understanding of developing PBS/RBS/WBS within a regulated FDA product development process.
- Multiple project orientation is required with strong acumen for execution and results
- Familiarity Solidworks, Pro-E, OrCAD or Altium (schematics capture, PCB layout), PSIM, MATLAB/PSPICE or Comsol or Ansys or Pro-mechanica is a plus.
- Experience in the design and development process and deliverables of complex electro-mechanical systems
- Experience in Design Verification and Validation process of complex electro-mechanical systems against IEC electrical interfaces, power quality requirements, and EMI/EMC, safety and protection requirements and other regulatory requirements relevant to energy-based medical devices
Responsible for overall compilation and maintenance of design history for system definition, development, qualification, transfer and changes for a family of complex electro-mechanical equipment, and includes the following:
- Functional oversight of technical projects including the definition of product development plans, design activities and deliverables, schedules and budgets using bottom up planning methodologies
- Ensures product design and supporting documentation meet appropriate safety and regulatory compliance. Acts as primary driver for project execution in development and overall product life cycle management, as well as obtaining third-party certification for compliance as needed
- Primary liason for the transfer of the product design into manufacturing from manufacturing prototyping through production validation
- Calls and conducts product level design reviews, build readiness reviews, pre-clinicl and clinical readiness reviews
- Development and implementation of device instructions for use, ensuring output complies with applicable external regulatory authorities. Oversees design verification and validation by subject matter experts for language translation
- Works closely with suppliers to resolve build and delivery issues, as well as conducting supplier trade studies, evaluations, and second source efforts.
About Protingent: Protingent is a niche provider of top Engineering and IT talent to Software, Electronics, Medical Device, Telecom and Aerospace companies nationwide. Protingent exists to make a positive impact and contribution to the lives of others as well as our community by providing relevant, rewarding and exciting work opportunities for our candidates.