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 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 SummaryAs a Mechanical Engineer II on our Resuscitation R&D team, you will support Sustaining Engineering efforts across our product lines. This includes the design of parts, assemblies, and enclosures for Defibrillator and Ventilator products or sub-systems. You will also collaborate with a cross-functional team of engineers and scientists in support of ingress protection, flow/pneumatics, shock/vibration control, EMI isolation, and thermal management per defined product goals and requirements. The team member is also expected to apply good design practices, procedures, and design criteria in the development of assemblies, parts, and subsystems.
Essential Functions

• Layout and develop new assembly and part designs.
• Complete engineering mechanics analysis, thermal/flow analysis, and tolerance analysis.
• Create detailed design documentation of new and revised products including part drawings, assembly documents, Bills of Materials, and purchasing specifications.
• Create Engineering Change Orders to enable control and release of designs to production under the ZOLL Quality System.
• Support document preparation for test and regulatory submission of new/existing designs.
• Support development of risk assessments and design/process FMEA for creation of the design history file.
• Lead and participate in technical design reviews for new or revised products and other projects as assigned.
• Lead or support troubleshooting activities, investigate the root cause to a successful conclusion, and help to resolve product complaints and CAPAs.
• Present new designs to suppliers and evaluate samples and prototypes for build and test.
• Develop test plans, DOEs and validation IQ/OQ/PQ protocols.
• Conduct part, subsystem, and system verification and validation testing of new designs complete with supporting documentation.
• Technical report writing, statistical analysis, and data evaluation.
• Conduct design of experiments and laboratory testing of new and legacy products and document results.
• Support management activity in preparation and maintenance of schedule, budget and project reporting.

Skills Requirements

• Ability to work with minimal oversight, i.e. “self-motivated.”
• A demonstrated commitment to continuous improvement of job related skills.
• Ability to design, document and analyze parts encountered in packaging of embedded systems (such as molded plastic housings, sheet metal, gaskets, PCBs, LCDs, cables and labels).
• Proficiency with SolidWorks including Part Design and Detailed Drawings (PDM and Simulation a plus).
• Working knowledge of drawing creation per ASME Y 14.5 2009.
• Strong written and verbal communication skills.

Required/Preferred Education And Experience

• Bachelor of Science in Mechanical Engineering.
• 3 to 5 years of Mechanical engineering and product design experience.
• Experience in medical or other highly regulated industry is strongly desired.
• Working knowledge of IEC 60601, FDA, GMP, ISO 13485:2003 are all a plus.
• SolidWorks CSWP preferred.

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.