Senior Project Manager, R&D

Location: Chelmsford, MA, United States of America

Resuscitation

ZOLL Medical is a growing, innovation-driven company on the forefront of delivering medical devices to save lives, and software solutions to improve efficiency. With customers in more than 140 countries, we continue to expand our reach, as well as our product offerings. Hospitals, emergency medical services (EMS), and others trust us to provide high-quality products and exceptional customer service. ZOLL products are used every day across the globe to save the lives of people who suffer sudden cardiac arrest. From Real CPR Help® technology—an industry first—to the world’s only wearable defibrillator, our capabilities and features set us apart. But none of this would be possible without the motivation and dedication of ZOLL employees, and we’re invested in their success.

We offer competitive salaries and a comprehensive benefits package. Join our team. It’s a great time to be a part of ZOLL!

Job Summary:

Based on priorities set by Program Directors, the Senior Project Manager is responsible for driving the new product development for the assigned product line(s).  The individual will be responsible for all projects related to the assigned Program for new developments, and coordinates with the  Sustaining Engineering group on post-release support.  Works closely with the engineering functional directors and cross-functional resources involved in the development, manufacture and regulatory requirements of the product line.

The position is technical in nature and the individual must have an engineering background in order to manage and contribute to the development of new products. The projects that will be managed include a mix of new product development, product line extensions, and sustaining engineering releases.

Product Line Responsibility:

  • Project management for ZOLL JAPAC programs.
  • Work with ZOLL Chelmsford and ZOLL JAPAC team, including ZOLL JAPAC commercial team, ZOLL China R&D and Production team to drive product development progress.
  • Lead the execution of assigned product development programs in accordance with established processes and procedures.
  • Lead and motivate cross-functional team performance toward the goal of completing projects according to the defined objectives.
  • Ability to balance electrical, mechanical and software development issues at system level. Must have the ability to implement projects outside technical area of expertise.
  • Develop detailed project work plans and schedules.
  • Effectively utilize problem solving skills and techniques to identify potential issues, assess their impact, and develop and implement mitigation and resolution plans and activities.
  • Employ excellent interpersonal, communication and negotiation skills with all levels of personnel and management.
  • Prepare and/or manage the preparation of all required project documentation.
  • Drive the requirements process for projects, capturing the customer, user, regulatory, standards bodies, ZOLL cross-functional organizations and ZOLL business needs.
  • Manage the quality and timeliness of the development deliverables across projects.
  • Manage the cross functional coordination required of the Program management for development projects.
  • Manage the project budgets on a monthly basis (establishing, justifying to management and controlling).
  • Ensure compliance to all ZOLL R&D SOP's and Guidelines.
  • Instill a culture of urgency with quality output on the development teams under Program Manager’s responsibility.

 

Essential Functions:

  • 80% Project management
  • 10% Continuous Improvement activity
  • 10% Other

Skill Requirements:

  • Knowledge of global standards and regulations for Design Controls, Risk Management, and Electrical Safety for Medical Devices.
  • Demonstrated aptitude for successfully managing multiple projects of varying complexity, within the specified guidelines, timeframes and budgets.
  • Demonstrated experience in working in a development capacity as a matrixed, cross-disciplinary partner
  • Strong written and verbal communication skills
  • Strong cross-functional/cross-disciplinary partnership behavior
  • Demonstrated ability to multitask and manage projects potentially impacted by change

Required/ Preferred Education and Experience:

  • Bachelor’s degree in the field of engineering or hard sciences
  • Masters or PhD preferred
  • PMP certification desired
  • Chinese communication skill is a plus
  • 5+ years managing technical product development. Experience with medical device capital equipment development required
  • 10+ years of experience as an engineer developing products, preferably in the medical device industry.
  • Experience managing and/or directing engineering resources for embedded medical device development preferred
  • Experience with regulatory filings for global medical devices (minimally, FDA 510(k)/CE, experience with FDA PMA desired)

Other Duties:

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job.  Duties, responsibilities, and activities will be reviewed periodically as duties and responsibilities change with business necessity.  Essential and marginal job functions are subject to modification.

 

ZOLL Medical Corporation appreciates and values diversity.  We are an Equal Opportunity Employer M/F/D/V. 

 

ADA:  The employer will make reasonable accommodations in compliance with the Americans with Disabilities Act of 1990