Project Leader - Invivo

The Project Leader is responsible for overall planning and execution of one or more product development projects from inception through to delivery to full production, and is responsible to assure high quality completion of the Design History File and Device Master Record for those products. Work includes managing requirements, leading design integration and assuring verification and validation of the completed product, and requires extensive interaction with customers, marketing, product implementation and manufacturing teams. Additional team leadership responsibility will be given to qualified candidates.

- Ownership of planning and execution of one or more product development projects, from inception (phase 1) to delivery into full production (phase 5).
- Responsible for gathering customer and system requirements, for leading system integration and for assuring verification and validation of the completed product. Involves extensive interaction with product marketing, key external users, product implementation and manufacturing teams.
- Ownership of the Design History File and Device Master Record. Responsible for design integrity, design manufacturability and regulatory compliance.
- Leadership of team(s) assembled to execute the work required.
- Opportunities to lead advanced development projects through feasibility completion and influence product strategy and direction.
Knowledge/Skills/Abilities:
- Strong organization and leadership skills "" demonstrated ability to drive closure in challenging circumstances and deliver on time with quality results.
- Excellent written and oral communications.
- Ability to work well with diverse functional groups and across multiple locations.
- Experience in hardware and/or software product design.

Required Skills:
Minimum Qualifications:
- Undergraduate degree in EE, ME, CS, CE, BME or Physics.
- 5 years product development experience.
Preferred Qualifications:
- Medical device design and development background strongly preferred.
- Experience in project management or systems engineering strongly preferred.
EEO/m/f/v/d





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