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.
