R&D Program Manager- Remote
AngioDynamics

Marlborough, Massachusetts
$110,000.00 - $140,000.00 per year

This job has expired.


JOIN A TEAM COMMITTED TO IMPROVING PATIENT CARE

It takes a team of talented people to become one of the world's leading providers of innovative medical devices.

AngioDynamics is dedicated to improving patient outcomes by focusing on the development of disruptive and differentiated technologies that address unmet patient needs and supporting professional healthcare providers around the world in the delivery of high-quality patient care.

We accomplish this through:

  • A Commitment to the Highest Standards of Quality
  • Relentless Innovation
  • Operational Excellence

Our employees receive the highest level of training and endeavor to be the best and the brightest in the medical device industry.

We are pleased to offer a comprehensive benefit plan that supports the overall health and wellness needs of our employees and their families.

JOB SUMMARY - To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.

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. Some projects may also involve external partners.

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

QUALIFICATIONS -The requirements listed below are representative of the knowledge, skill or ability required.

Education and Experience
  • Bachelor Level of Degree in a Technical field of study
  • 10 years of demonstrated experience in a project management role working in a technical discipline in Medical Device. Preferably including knowledge of medical capital equipment and disposable device development, validation and production scale up.
  • Previous experience in an a fast paced cross functional work environment
  • Any preferred education, experience or certifications: MBA preferred, PMP Certification preferred
Skills/Knowledge
  • Demonstrated knowledge and experience in related technical field
  • Demonstrated experience leading programs in a cross-functional environment
  • Demonstrated ability to function in a fast-paced, growth industry and work environment
  • Demonstrated ability to influence inside and outside of the organization, across all levels of an organization
  • Proficient in the following computer software applications: MS Office products, Microsoft Project, Outlook, Word, Excel, PowerPoint, and Project
  • Exceptional interpersonal skills. Strong organizational skills. Strong communication skills (written and verbal).Ability to effectively communicate both internally and externally. Ability to read and interpret documents such as safety rules, operating and maintenance, instructions, and procedure manuals. Ability to write routine reports and correspondence.

PHYSICAL/WORK REQUIREMENTS

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job:
  • Work safely and follow all OSHA regulations and company safety policies and procedures.
  • For all on-the-job injuries or accidents, must notify manager/supervisor immediately.
  • Exposure to (insert any extreme climate and/or work conditions) standard office environment
  • Ability to frequently lift and/or move up to 15 lbs.
  • Ability to occasionally lift and/or move up to 15 lbs.
  • Ability to regularly sit or stand for extended periods of time
  • This position requires some travel up to 10% of the time

EMPLOYEE ACKNOWLEDGMENT

By signing the Learning & Development training form, I understand that the company reserves the right to add to or revise an employee's job duties at any time at its sole discretion. All requirements are subject to possible modification to reasonably accommodate individuals with disabilities. This document does not create a contract of employment between AngioDynamics and any individual, express or implied. All employees are, and remain, employees-at-will.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other legally protected status.

The Company will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant.

AngioDynamics does not accept resumes or candidate submissions from third-party recruiters and/or vendors who are not expressly under current written contract.

Your ultimate salary may vary depending on your job-related skills, knowledge, and experience.


This job has expired.

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