Mechanical Engineer Ii, Consumables

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
As a Mechanical Engineer II, Consumables, you will collaborate with other team members and report to the Manager of Consumables Engineering. You will be responsible for projects and tasks including the development of new product designs, selection and specification of materials, and development of manufacturing techniques for defibrillation, monitoring and pacing (ECG) electrodes as well as other specialty products and consumables for present and future ZOLL devices. You will also be expected to provide engineering support to Production and Customer Service departments on existing products.
Essential Functions:

• Design, development, and tooling of new disposable electrodes and other specialty products in compliance with 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 Department 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.
• Support management activity in preparation of schedule, budget, and project reporting.
• Support sustaining engineering projects, including response to customer complaints, changes in compliance requirements, and feature extensions, component obsolescence, manufacturing and manufacturing test issues.
• Some travel may be required. This entails interacting with other corporate offices, customers, vendors, and test facilities.

Skills Requirements:

• Effective problem-solving skills.
• Customer focus both internally and externally.
• Strong written and verbal communication skills.
• Ability to manage confidential information with appropriate discretion and care.
• Proficiency with SolidWorks including Design, Drawing, and PDM.
• Working knowledge of drawing creation per ASME Y 14.5 2009.
• Ability to design, document, and analyze parts encountered in the development of electrodes and consumables (such as molded plastic housings, gaskets, PCBs, cables, and labels).
• Demonstrated ability to multitask and contribute to projects potentially impacted by change.
• Ability to work with minimal oversight, i.e., "self-motivated."
• A demonstrated commitment to continuous improvement of job-related skills.

Required/Preferred Education and Experience:

• Bachelor of Science in the field of mechanical or biomedical engineering.
• Requires a minimum of 5 years of related experience.
• Experience in medical device or other highly regulated industry experience preferred.
• Familiarity with the use of mechanical and electrical test equipment.
• Analytical, investigative, and problem-solving skills required.
• 510K experience helpful.

Other Duties:
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities will be reviewed periodically as duties and responsibilities change with business necessity. Essential and marginal job functions are subject to modification.
ZOLL Medical Corporation appreciates and values diversity. We are an Equal Opportunity Employer M/F/D/V.
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.