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.

ZOLL Cardiac Management Solutions offers a unique portfolio of novel technologies designed to deliver better insights and better outcomes. On any given day, clinicians utilize these ZOLL products for tens of thousands of cardiac patients around the world:

• LifeVest, the world's first wearable defibrillator, has been trusted to protect more than 1M patients at risk of sudden cardiac death.
• HFMS (Heart Failure Management system) is a non-invasive, patch-based device that monitors pulmonary fluid levels and has been shown to reduce heart failure readmissions rates by 38 percent.
• TherOx Super Saturated Oxygen (SSO2) Therapy is the first FDA-approved therapy since the stent 20+ years ago to reduce infarct size in patients with the most severe heart attacks.

Heart disease is the leading cause of death for both men and women in the U.S. At ZOLL, your work will help to ensure cardiac patients get the life-saving therapy they need.

ZOLL has been Pittsburgh's Manufacturer of the Year, one of Western PA's Healthiest Employers, and even one of Pittsburgh's Coolest Offices. But it's our unique opportunity to impact people's lives that makes ZOLL the ideal place to build your career.

Job Type

Hybrid

Job Summary

The TherOx Director of R&D is responsible for the methodical, disciplined approach to the conception, design, development, and technical management of ZOLL's product realization process for medical devices. Primarily, the Director of R&D collaborates with CMS R&D and TherOx Product Management to direct projects for sustaining and upgrading TherOx's products. The Director of R&D translates patient's and/or stakeholder's needs into engineering system level requirements and establishes the essential functionality in the early stages of product or service development cycle. Once needs are defined, the Director of R&D leads the major activities of the multi-functional engineering team via ZOLL processes and good engineering practices throughout the product development life cycle, including system requirements, system architecture, detailed requirements, product design and design transfer to manufacturing. In addition, the Director of R&D will assist the engineering development team through engineering verification/reliability testing, FMECA analysis, and risk management, as needed. The Director of R&D also supports review of clinical feedback.

Essential Functions

• Collaborates with CMS R&D and TherOx product stakeholders (Clinical Affairs, Regulatory Affairs, Operations and commercial team) to identify and prioritize patient and/or stakeholders needs for the product throughout the development life cycle.
• Drives activities to generate system level and detail level engineering requirements from market requirements/needs and technical investigations
• Drives R&D team in technical investigations to refine architectural requirements and identify technical risks and design risks.
• Plans projects and manages budgets to ensure that people and resources are applied in an efficient and effective manner to meet objectives.
• Drives the R&D team to assess product risk using ZOLL’s Risk Management process during the design, verification, and validation phases of the project.
• Collaborates with engineering managers and technical program managers to identify resource needs.
• Manufacturing liaison with oversight of production inventory for TherOx devices
• Formulate long term objectives and standards of performance for the department
• Recruits, develops and retains high-performing talent
• This position is located at ZOLL Cardiac Management Solutions offices. Evening and weekend work may at times be required.

Required/Preferred Education and Experience

• Bachelor's Degree or equivalent industry experience in engineering or related discipline required
• Master's Degree preferred
• 10+ years of experience in R&D project management required
• Proven track record of performing the above functions and responsibilities required
• Systems engineering, embedded software and/or electromechanical device experience preferred
• 15+ years of product development experience in medical devices preferred

Knowledge, Skills and Abilities

• Demonstrated ability to plan, direct, and conduct research and development activities
• Demonstrated leadership skills
• Strong analytical and decision-making skills
• Excellent verbal and written communication skills.

Travel Requirements

• 10% Occasional travel should be expected. Approximately 4-6 times per year, mostly within the U.S.

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
• Lifting - Occasionally
• Talking - Frequently
• Hearing - Frequently
• 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.