Director of Research and Development
ReShape Lifesciences is seeking a Director of Research and Development who will oversee the R&D/Engineering department and will be responsible for researching/developing weight loss related medical device products or accessories. The R&D Director will also be required to facilitate design control activities in conjunction with various organizations that assures the final product meets the agreed upon requirements.
Essential Job Functions (including but not limited to):
- Creates R&D project budgets, timelines, and cost models.
- Project manage design control activities including design verification/validation for products that are in R/D development.
- Provides, either self or in coordination with other departments, all necessary top level documents describing the product and its development path, including marketing requirements, product specifications, regulatory and clinical plans, product development timelines, product development schedules, product outsourcing, cost etc.
- Provides the product development strategy, processes and procedures, including testing and validation, with a goal to produce products that meet clinical and regulatory requirements for class III and class II medical devices.
- Assures approval of the product definition and development plans from senior management and provides regular updates on the progress towards meeting objectives.
- Partners with Regulatory and Quality to ensure the product is in compliance with ISO, FDA, and other regulatory requirements.
- Travels to key clinical sites from time to time to evaluate product performance and gather input to improve future products.
- Evaluates and shares insight into the competitive landscape and any SWOT activities initiated by Reshape Lifesciences.
- Identifies Intellectual Property (IP) opportunities and reviews patents to strengthen IP position and freedom to operate.
- Leads hardware architecture definition for next generation products.
- Management and personnel functions for members of the R&D group, including assessing man power requirements, recruiting, hiring, training, performance evaluation, reporting and budget management.
- Performs program management activities for a number of projects within the development organization and supports project management activities of others. These activities include project planning with estimates of cost, required resources and project schedule, providing direction to cross functional project teams, consultants, and contractors, tracking progress against plans, schedule recovery to deal with unanticipated events, and reporting schedule status.
- Participates in and leads cross functional activities, such as corporate management meetings, project and design reviews. Works with all other departments including pre-clinical, clinical, regulatory, research, finance, legal, IP management, purchasing, production, quality, and advanced development to achieve corporate goals.
- Coordinates design evaluation and verification activities on prototype and product versions of sub-assembly and final assembly devices.
- Participates in evaluating, selecting, and assessing supplier capabilities and improving supplier performance as required.
- Develops and maintains Standard Operating Procedures with emphasis on Product Development and Design Controls.
- Develops the manufacturing of devices for next generation products, clinical studies and pre-clinical research.
Education and Experience:
- BS degree in an engineering discipline with 10+ years experience in medical device R&D.
- 5+ years in a managerial role of a functional design group is required; Implantable medical device experience recommended.
- Strong knowledge of product development for medical devices including all applicable FDA regulations and requirements of other external regulatory bodies.
- Comprehensive working knowledge of medical device design and must know and understand the regulatory and compliance requirements that govern a heavily regulated industry (medical device, defense, or telecommunications, etc.)