Manufacturing Engineer

About the role

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.

Develop, validate, document, maintain, and support processes, equipment, and process controls to assure that electro-mechanical products meet specifications and applicable regulations. Develop, implement, and manage value improvement projects which incorporate a Lean/Six-Sigma approach. Provide timely and effective development and implementation of manufacturing standards and process specifications to assure achievement of operations objectives. Implement production testing methods and procedures to assure that products meet specifications. Perform analyses on quality information to proactively improve potential problems and capture improvement opportunities.

Responsibilities

• Support new product development teams as manufacturing representative, ensuring a successful transfer of design into production.
• Evaluate new product designs to influence Design for Manufacturability, Design for Serviceability and Design for Cost by providing feedback to R&D during early phases of projects.
• Develop and improve process flows to ensure quality and production efficiency.
• Develop work plans as inputs to project schedules.
• Actively participate within a team to develop and improve the manufacturing processes for existing and new products.
• Develop and maintain robust Master Validation Plans for manufacturing processes.
• Create and execute IQ, OQ, PQ, TMV, Gage R&R protocols as required in the Master Validation Plan.
• Lead cross-functional team to create Process Failure Modes and Effects Analysis as part of internal risk management program.
• Lead implementation of