Program Manager

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Program Manager

Durham, NC

March 2022

Description
HemoSonics, LLC is seeking a Program Manager who will oversee Program & Project Management of new in-vitro medical diagnostic products.

Key Attributes of the Successful Candidate:

  • Proven ability to communicate with Senior Management, Marketing/Product Management, and Commercial Operations Functional Managers.
  • Proven ability to provide technical leadership within a team and influence without authority.
  • Effective analytical and quantitative skills.
  • Effective verbal and written communication skills.
  • Effective organizational skills.
  • The ability to read, understand and conform to policies and procedures.
  • Demonstrated ability to work effectively on an interdisciplinary team.
  • Demonstrated ability to commit to assigned tasks.
  • Ability to learn and understand diverse and complex systems.
  • Should possess the computer skills necessary to utilize commercial software packages (project planning, data base analysis, spread sheet, word processing and presentation).

Key Responsibilities:

  • Manage Concept project teams, ensuring that concept phase deliverables are completed on schedule.
  • Manage New Product Development (NPD) and Design Change project teams engaged in bringing products to commercialization in a rapid, cost effective and efficient manner while ensuring that product development related activities and projects adhere to Design Regulations as detailed in CFR 21, Part 820 Subpart C, and ISO 13485.
  • Develop and maintain requirements, project design/development plans and project schedules, seeking input from other functions as necessary.
  • Create and maintain Hazard Analysis documents.
  • Provide senior management with project and program metrics and regular updates in order to manage the project portfolio.
  • Drive projects to on-time completion while meeting defined specifications.
  • Ensure that all appropriate functional areas are kept apprised of project progress, issues, risks and required interactions.
  • Work with departmental leaders to obtain the appropriate levels of support (headcount, expertise, etc.) to staff the cross-functional NPD project teams.
  • Ensure that key stakeholder requirements (Customer, Marketing, FDA, OSHA, Management, Manufacturing, Quality, etc.) are key drivers of the development process.
  • Work with the appropriate Commercial Operations and vendor functions to develop technical support and launch plans.
  • Develop metrics to track project and portfolio efficiency and productivity.
  • Lead design reviews and commercial readiness reviews.
  • Provides senior management with regular updates.
  • May provide guidance and work direction to lower-level project team members.
  • May participate in internal project meetings as appropriate for background.

Education and Experience Required:

  • 2 years of related experience with PhD in engineering, life sciences, or related discipline; or
  • 4 years of related experience with MS in engineering, life sciences, or related discipline; or
  • 8 years of related experience with BS in engineering, life sciences, or related discipline.
  • Knowledge of stage-gate NPD product development processes.
  • Experience working in a matrix environment.
  • Knowledge of FDA Design Regulations preferred.
  • Experience developing FDA regulated medical devices strongly preferred.
  • Experience developing in-vitro diagnostic systems strongly preferred.

This is an onsite position at our Durham, NC facility and will require some travel for work, up to 20%. HemoSonics requires employees to be fully vaccinated against COVID-19 or meet the requirements for medical or religious exemption.

To apply, please email your cover letter, resume and salary requirements to: careers@hemosonics.com.

HemoSonics, LLC is an equal opportunity employer. All applicants will be considered for employment regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.

Why HemoSonics?

HemoSonics is a growing team of scientists, engineers, regulatory and business professionals all focused on transforming the way clinicians manage coagulation dysfunctions by providing comprehensive, timely information on coagulation status at the point of care.

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