Job Title

- Provide project and technical leadership as it relates to Systems to cross functional teams including external partners for projects through conceptualization, development, product registration and commercialization. - Establish and foster strong collaborative relationships with internal and external design/development partners, manufacturing partners and service providers. Provide critique and design guidance to ensure proper implementation and traceability of design outputs as compared to design inputs. - Work closely with Product Managers in collection of user needs/feedback on product requirements and concepts - Lead the requirements development and management process, incorporating risk management elements as required. - Ensure compliance with product security and cyber security policies and support efforts to author local SOP’s to ensure compliance. - Support the optimization of design control elements to comply with medical device regulations. - Implement product design with the intention of optimizing design for manufacturability and testability. - Consider Cost of Goods and lifecycle when selecting components for device designs. - Develop engineering solutions, investigate competing technologies while considering the patent landscape, and protect engineering solutions by filing timely invention disclosures and working closely with the IP Legal team as needed. - Establish and maintain detailed project plans, define risks and recommend contingency plans as required. - Provide support for Risk Management activities, working with Design Assurance. - Lead all technical project execution activities and oversee the development of statistically sound design verification protocols/reports, design validation, and delivery system qualification activities. - Lead the system safety certification process to standards such as EN60601-1, EN60601-1-2. Ensure software is developed in compliance with the methodologies of EN 62304. - Provide technical support to Marketing for technical brochures, training programs, and technical presentations to customers and the sales force. - Maintain knowledge of technical product landscape, competitive products and procedural trends for target procedural areas.