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Resuscitation, ZOLLMED.com

At ZOLL, we're passionate about improving patient outcomes and helping save lives.We provide innovative technologies that make a meaningful difference in people's lives. Our medical devices, software and related services are used worldwide to diagnose and treat patients suffering from serious cardiopulmonary and respiratory conditions.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!Job SummaryThis 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 w ork 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..Essential Functions

• 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 the 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 on a yearly basis, 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.

Required/Preferred Education and Experience

• Bachelor’s degree in the field of electrical engineering, software engineering, or hard sciences required and

• Master's and/or PhD degree preferred

• 15+ years of experience in development of electrical/mechanical / software embedded medical devices required and

• 15+ years of direct management experience required

• Directing engineering resources for embedded medical device development required

Knowledge, Skills and Abilities

• 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

Physical Demands

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.

• Standing - Occasionally

• Walking - Occasionally

• Sitting - Constantly

• Talking - Occasionally

• Hearing - Occasionally

• Repetitive Motions - Frequently

ZOLL is a fast-growing company that operates in more than 140 countries around the world. Our employees are inspired by a commitment to make a difference in patients' lives, and our culture values innovation, self-motivation and an entrepreneurial spirit. Join us in our efforts to improve outcomes for underserved patients suffering from critical cardiopulmonary conditions and help save more lives.

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