Sr. Director, R&D

ZOLL Medical Corporation•Chelmsford, MA

19h

About The Position

The Acute Care Technology division of ZOLL Medical Corporation develops and delivers innovative lifesaving products and software solutions to EMS, hospital, public safety, and military customers globally. Our dedicated employees take pride in their commitment to improving patient outcomes while delivering world-class customer service. At ZOLL, you won’t just have a job. You’ll have a career—and a purpose. Join our team. It’s a great time to be a part of ZOLL! This individual will be responsible for leading new product development for the assigned product line and projects. The individual will be responsible for all programs / projects for the assigned product lines from new development through sustaining and manufacturing support. The individual will work closely with engineering functional directors and cross functional resources involved in the product development, manufacturing, and regulatory requirements of the product line. As a member of the R&D program management staff reporting directly to the Vice President, Program Management, contribute significantly toward departmental initiatives for quality, process and talent development. As an R&D senior director with a program management focus, the Senior Director, R&D, will often lead and contribute significantly toward continuous improvement of the program management processes and tools for the R&D department. This latter activity will be a shared activity with Vice President, Program Management, and other departmental vice presidents/ directors/ managers.

Requirements

Bachelor’s degree in the field of electrical engineering, software engineering, or hard sciences required
15+ years of experience in development of electrical/mechanical / software embedded medical devices required
15+ years of direct management experience required
Directing engineering resources for embedded medical device development required
Proven leadership and management skills, with the ability to inspire, motivate, and develop a diverse and high-performing program management team
Evidence of progressive advancements in R&D
Broad technical depth in electrical, mechanical, and software development
Extensive experience in product development to meet global regulatory and standards requirements
Experience with successful regulatory filings for global medical devices (minimally, FDA 510K and MDR CE Mark; ideally FDA PMA and other global authorities)
Demonstrated experience working in a product development capacity as a matrixed, cross-disciplinary partner (i.e., as a project manager/core team leader and core team member), with strong cross functional/cross discipline partnership behavior
Strong project management skills, including scrum under an Agile framework
Strong understanding of medical device product development
Strong process focus and experience
Strong business acumen
Excellent communication (written and oral) and interpersonal skills with the ability to communicate effectively with internal and external stakeholders at all levels
Proven track record of making strong business and technical decisions in the face of ambiguity and conflicting requirements
Demonstrated ability to multitask and manage projects potentially impacted by change
Analytical mindset and strong critical thinking and problem-solving skills
Ability to handle confidential information with appropriate discretion and judgement

Nice To Haves

Master's and/or PhD degree preferred

Responsibilities

Product line responsibility
Lead program management for product line projects
Drive the requirements process for projects, capturing the customer, user, regulatory, standards bodies, ZOLL cross functional organizations and business needs
Manage the quality and timeliness of the development deliverables across projects.
Manage the cross functional coordination required of program management for development projects
Manage project managers and engineering staff reporting directly and indirectly as appropriate.
Manage matrixed engineering staffs’ daily activities and deliverables during projects
Manage the project budgets monthly (including establishing, justifying budgets and spend, and controlling expenses)
Ensure compliance to all ZOLL R&D SOPs and Guidelines
Instill a culture of urgency with quality output on the development teams
Deliver yearly skills assessment for reporting staff
Deliver yearly training plans and execution of such for reporting staff
Develop program management and engineering talent and leadership and contribute to annual R&D talent planning
Participate in yearly strategic planning and budgeting processes
Identify yearly improvements to our engineering and program management processes and tools; facilitate change as appropriate
Lead, as appropriate, continuous improvement of processes, tools, and techniques for the program management function and its cross integration with the other R&D functions and cross-functional organizations