Director New Product Development

Woburn, MA, US
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Director, NPI will lead the efforts for innovation and development in new commercial products from early-stage product concepts through market launch. This position is responsible for developing the strategy for capital systems and consumables, including early supply chain, design transfer from R&D to Manufacturing, any in-house R&D manufacturing efforts as well as project management of interfaces with external resources.

Essential Duties and Responsibilities:
  • Develop and execute the NPI strategy and roadmap for medical devices, from concept to launch.
  • Partner with cross functional teams in marketing, clinical, regulatory, quality and manufacturing operations to develop overall strategy including key deliverables, corporate objectives, timelines, budget projections, milestones, and key decision points and  ensure compliance with regulatory requirements.
  • Coordinate the product design, development, testing, and manufacturing processes to ensure that all products are manufactured to specification.
  • Ensure adherence to regulatory requirements such as FDA, ISO, and other applicable regulatory standards.
  • Manage project schedules, budgets, and resources to ensure timely product launches.
  • Develop and implement quality control procedures to ensure that products meet specifications and regulatory requirements.
  • Collaborate with marketing and sales teams to develop product launch plans, sales collateral, and promotional materials.
  • Identify and manage risks and issues that may impact the success of the product launch.
  • Ensure effective communication and collaboration across all stakeholders involved in the product launch.
  • Lead and develop the team members and as well as consultants, advisors, and vendors.
  • Ensure product development activities meet or exceed customer requirements.
  • Lead design transfers from R&D to Manufacturing.
  • Partner with Manufacturing Operations to identify, assess and qualify Contract Manufacturer(s) for both capital and consumable elements, management of on-going production.
  • Manage development of prototype, product for clinical use and pilot production processes and implement of test protocols and testing.
  • Ensure meaningful metrics to track progress.
  • Provide scope, status, and scheduling updates to leadership
  • Effectively communicate the development strategy to company stakeholders including potential partners and investors
  • Other duties as assigned.

Education and/or Experience:
  • BA/BS in Electrical Engineering/ Mechanical Engineering or Software or related field, advance degree preferred
  • 5+ years of experience in NPI management, preferably in a regulated industry
  • Strong project management skills, including the ability to manage multiple projects simultaneously.
  • Experience in leading cross-functional teams and managing stakeholders; Management experience of various engineering disciplines
  • Knowledge of product development processes, quality systems, and regulatory requirements, including FDA and ISO.
  • Excellent communication and interpersonal skills.
  • Ability to work independently and make decisions in a fast-paced, dynamic environment.
  • Strong analytical and problem-solving skills.
  • Successful track record of managing and leading high-performance teams, focused on meeting and exceeding expectations.
  • Ability to manage diverse and simultaneous projects of various complexity.
  • Experience in Class II medical aesthetic devices is preferred
  • Creative thinker who is willing to take on innovative product risk while balancing compliance requirements and meeting timelines.
  • Ability to solve complex engineering related challenges
  • Broad knowledge of medical device operations and quality guidelines and regulations
  • Self-starter, strong sense of urgency, assertive, proven manager with a strong results orientation, positive “can do” attitude
  • High level of personal and professional integrity and trustworthiness with strong work ethic and the ability to work independently with minimal direction.
  • Topnotch interpersonal, analytical, organizational and leadership skills, training, and the ability to stay abreast of recent industry advancements
  • Outstanding written and verbal communication and presentation skills. Ability to present and effectively communicate complex concepts to the audiences of various backgrounds and knowledge levels
  • Excellent computer skills and familiarity with Microsoft Office and other related software
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