Senior Product Development Engineer

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 Resuscitation 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 Summary

To develop new product designs, materials, and manufacturing techniques for defibrillation, monitoring and pacing, (ECG) electrodes and other specialty products. Provide engineering support to Production Department and Customer Service on existing products.

Essential Functions

• Design, development and tooling of new disposable electrodes and other specialty products in compliance with Bio-Detek design control procedures.
• Develop specifications of new materials for use with disposable external defibrillation, pacing, monitoring, (ECG) and other specialty electrodes.
• Assist Regulatory in preparation of 510K submissions to FDA relating to new or revised designs including required validation studies.
• Support the Production Dept. in resolving manufacturing problems. Participate in investigation of and resolution of field incidents, customer complaints and other quality issues requiring technical support.
• Assist in preparation of in-house specifications and documentation for new or revised designs consistent with FDA or ISO requirements.
• Perform all testing and recording of data in laboratory environment as required by a specific project on an as needed basis.
• Supervise R & D Technicians and Lab.
• Lead projects as assigned and provide technical leadership to engineering team.
• May have direct reports

Required/Preferred Education and Experience

• Four-year degree in Bio-medical/Electrical/Mechanical Engineering or related discipline. required
• 10+ years of related experience required

Knowledge, Skills and Abilities

• Experience in medical device or other highly regulated industry experience preferred
• Any similar combination of education and experience
• Computer proficient (Word, Excel and 3D CAD).
• Familiarity with the use of mechanical and electrical test equipment.
• Analytical, investigative, and problem-solving skills required.
• 510K experience helpful.

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.