ZOLL's TherOx Director of R&D is responsible for the methodical, disciplined approach to the conception, design, development, and technical management of ZOLL's product realization process for medical devices, specifically directing projects for sustaining and upgrading TherOx's products to meet patient and stakeholder needs.
Requirements
- Systems engineering, embedded software and/or electromechanical device experience preferred
- 15+ years of product development experience in medical devices preferred
Responsibilities
- Translates patient's and/or stakeholder's needs into engineering system level requirements and establishes the essential functionality in the early stages of product or service development cycle.
- Leads the major activities of the multi-functional engineering team via ZOLL processes and good engineering practices throughout the product development life cycle, including system requirements, system architecture, detailed requirements, product design and design transfer to manufacturing.
- Assist the engineering development team through engineering verification/reliability testing, FMECA analysis, and risk management, as needed.
- Supports review of clinical feedback.
- Drives activities to generate system level and detail level engineering requirements from market requirements/needs and technical investigations
- Drives R&D team in technical investigations to refine architectural requirements and identify technical risks and design risks.
- Drives the R&D team to assess product risk using ZOLL’s Risk Management process during the design, verification, and validation phases of the project.
Other
- Hybrid
- Bachelor's Degree or equivalent industry experience in engineering or related discipline required
- Master's Degree preferred
- 10+ years of experience in R&D project management required
- Proven track record of performing the above functions and responsibilities required
