R&D Program Manager - Boston, United States - Haemonetics Software Solutions

Description

Haemonetics is committed to the protection of personal data in accordance with applicable laws and regulations.
The editor and data controller is Haemonetics Corporation, 125 Summer Street, Boston, Massachusetts, 02110 U.S.A. The global Data Privacy Officer of Haemonetics can be reached at this address.
We are constantly looking to add to our core talent.

If you are seeking a career that is challenging and rewarding, a work environment that is diverse and dynamic, look no further — Haemonetics is your employer of choice.

The Program Manager is

responsible to plan, execute, manage risk, manage critical path and commercialize NPI and large sustaining projects according to strict deadlines and within budget.

This includes engaging resources and coordinating the efforts of team members and third-party organizations to deliver projects according to plan.

Accountable to create project team governance to engage cross functional accountability of costs, schedules, scope, resources and track risks of programs and multiple integrated projects.

As a Program Manager the candidate will:
Analyze project risks and identify their impact while developing mitigation strategies, identify and manage critical path, ensure appropriate program level definition across all stake holders and manage the program from concept to commercialization
Create and execute project work plans and revise as appropriate to meet changing needs and requirements.
Manage day-to-day operational aspects of a project and scope. Maintain compliance with the Stage Gate Process quality system and help to enforce standard operating procedures (SOPs). Escalates appropriately when required.
Mitigate team conflict and communication problems.

Motivate team to work together in the most efficient manner.
Leverage project management tools to assist in the development of and adherence to a schedule and report status.
Own and create appropriate levels of governance to ensure alignment and clear objectives
Accountable for product design history file, regulatory standards, and compliance to QMS procedures
Keep track of lessons learned and shares those lessons with team members

SUPERVISORY RESPONSIBILITIES:
Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring, training employees; planning, assigning and directing work; addressing complaints and resolving problems.

QUALIFICATIONS:
Required/Preferred
Bachelor's Degree
BS in Engineering

EXPERIENCE:
Required/Preferred
10+ years
Experience with medical device development (Class II/III) under FDA Quality Systems Regulations
Experience with medical device development under FDA Quality Systems Regulations, CE Marking, and ISO Quality Systems
Technical program management in cardiovascular, biomaterial, or related product development

PHYSICAL DEMANDS:

A thorough completion of this section is needed for compliance with legal standards such as the Americans with Disabilities Act.

The physical requirements 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.
Sit; use hands to finger, handle, or feel objects, tools, or controls.
Stand; walk; reach with hands and arms; and stoop, kneel, crouch, or crawl.
Lifting/moving up to 10 pounds.
Exposure to moving mechanical parts, vibration and/or moderate noise levels.
Exposure to hazardous chemicals or other materials.
Throughout our history, we have earned a solid reputation for product innovation, technical expertise, and operational excellence.

Today, our products, internal research and development, marketing partnerships, and product acquisitions reflect our unwavering commitment to provide safe and available blood for patient transfusions and for use in pharmaceuticals.

We rely on our talented global workforce to help us achieve our mission of providing innovative medical devices that advance the safety, quality, and availability of the world's blood supply.

To achieve our business goals and objectives, we are committed to attracting and retaining the best and brightest talent while offering a challenging, dynamic, and exciting work environment that offers professional growth and development.

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