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Program R&D Manager in Marlborough, MA at Angiodynamics, Inc.

Date Posted: 9/6/2018

Job Snapshot

Job Description

This position is responsible for the program management of several medical device projects and products simultaneously. The specifics of the duties can vary depending upon project deliverables as dictated by the nature of the product franchise and regulatory requirements. This role is expected to contribute to the evolution and ongoing improvement of the Product Development Process by example and providing constructive input. Strong cross functional interactions across R&D, Quality, Finance, Operations, Marketing, Intellectual Property, Sales, Quality Assurance and Regulatory Affairs, Supply Chain, Clinical, and Business Development are necessary to achieve the desired business goals.

Essential Duties and Responsibilities
  • Effectively lead complex cross functional, multi-site teams, including internal and external groups (OEMs), in a collaborative environment completing project deliverables per target timelines and requirements. Programs may have more than one component, i.e. hardware and disposables.
  • Develop strong internal and external networks to identify best PM practices, connect with internal functions to recommend and implement process improvements.
  • Identify and implement state of the art planning, tracking, budget, and other tools used for metrics and be able to articulate a point of view on benefit and usage of tools.
  • Establish, track and report on performance to project budgets using common finance metrics and planning tools. Communicate risks and opportunities to the business.
  • Lead team through project planning processes to predict timelines and establish critical path, track and report on progress to plan.
  • Ensure all project deliverables adhere to internal quality requirements and align with the needs of appropriate US and international regulatory agencies.
  • Pro-actively identify risks to budget, performance, schedule and work with team members to identify means to ameliorate risk, communicate risk and propose resolutions to management
  • Work with appropriate team members to ensure compliance with applicable worldwide requirements ensuring compliance with all FDA, ISO, GMP, GLP, CE requirements, meeting domestic and international design control regulations. Be up to date and anticipate impact of changing standards to programs.
  • Drive activities to support internal design control process and ensure teams are prepared for phase reviews
  • Review legal contracts from project perspective for applicability to project milestones, etc.
  • Coordinate team support and guidance to Clinical Affairs team for physician evaluations, animal studies, and clinical trials required to effectively assess the design of a new product.
  • Be an active part of the implementation and ongoing improvements of new business processes under development
  • Mentor project management team members assisting in their execution and development in project management skills, and develop strong influencing behaviors to drive business outcomes.
  • Working knowledge of regulatory agency standards applicable to a range of countries, company quality standards and corporate policies.
  • Must be able to travel domestically and internationally as business needs demand.
  • May perform other duties as assigned

Regulatory Responsibilities

  • Manages in order to ensure compliance with all relevant regulatory/legal requirements

QUALITY SYSTEMS DUTIES AND RESPONSIBILITIES

  • Individual Contributor - Build Quality into all aspects of their work by maintaining compliance to all quality requirements

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