Advisory Mechanical Engineer - V&V

Reference #: R13840 CMS, Softaid.local 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 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. 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 Lead engineer responsible for the planning and testing related to the mechanical design of ZOLL`s life-saving medical devices. Also provides coaching and mentoring of associates within the V&V engineering team. Additional responsibilities include development and maintenance of test plan and report documentation, participation in technical reviews, work planning and estimation, and providing technical guidance and support to other internal cross-functional groups. The Advisory Mechanical Engineer-V&V is an individual who can provide cross-functional technical leadership on projects. This position requires the candidate to possess a high level of creativity, apply advanced knowledge of engineering principles and provide project technical leadership. Essential Functions Author and lead implementation of Verification and Validation test plans, test procedures and document/report on activities. Contribute to Verification and Validation requirements development and traceability. Participate in design reviews. Perform test set-up/execution and initial troubleshooting during testing. Technical project management of subcontractors performing Verification and Validation testing. Collaborate with internal customers including Engineering, Quality, Manufacturing, Project Management, Marketing, Service, and Regulatory Affairs. Support V&V / Compliance activities for Lifecyle Engineering/Sustaining efforts Employs the appropriate level of engineering rigor to mechanical design testing, ensuring product robustness, reliability, and patient safety. Generate and processes Engineering Change Orders. Cross train and provide Sustaining Engineering support as necessary. Coach other engineers and delegates aspects of projects to them. Use interpersonal skills to coordinate with internal and external teams effectively. Required/Preferred Education and Experience BS degree in Mechanical Engineering or a related discipli e required. Typically, 10+ years related industry experience with progressively increasing responsibility, including a track record of successful project completion required. Knowledge, Skills and Abilities Strong leadership and collaboration skills. Excellent communication (written/verbal) skills. Excellent problem-solving skills Experience using test equipment. A wide degree of independent judgement. Experience working with requirements and test management tools (e.g. Jama Connect) Proficient in Microsoft Office Suite. Experience with standards and familiarity with regulations would be a plus. Experience interfacing and interacting with 3rd party test labs would be a plus. Experience with medical devices would be a plus. Experience with wearable electronics would be a plus. 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's 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. #LI-KH1 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. ZOLL LifeVest is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, age, status as a protected veteran, status as a qualified individual with a disability, or any other protected class status.

Created: 2024-11-02