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 Cardiac Management Solutions division of ZOLL Medical Corporation develops products to protect and manage cardiac patients, including the LifeVest wearable cardioverter defibrillator (WCD), the ZOLL cardiac monitor, and associated technologies.
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. To date, the LifeVest WCD has been worn by hundreds of thousands of patients and saved thousands of lives.
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 purpose

Serve as an advisor to internal and external business groups to support development, validation, maintenance and support of processes, equipment, and process controls to assure that electro-mechanical products meet specifications and applicable regulations. Identify, 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. Identify and implement advance production testing methods to assure that products meet specifications. Perform ongoing analyses on quality information to proactively improve potential problems and capture improvement opportunities.

Duties and responsibilities

• Serve as a manufacturing advisor to support new product development teams to ensure a successful transfer of design into production.
• Advise new product design teams on Design for Manufacturability, Design for Serviceability and Design for Cost to achieve operational goals.
• Assess product testing requirements and provide input to test developers on selection of instrumentation and test methods to optimize the capability of the measurement system.
• Identify advanced methods and equipment for proposals to develop and improve process flows to ensure quality and production efficiency.
• Develop, manage, and communicate project schedules across a cross-functional team.
• Lead teams in the development and improvement of the manufacturing process for existing and new products.
• Support development and maintenance of robust Master Validation Plans for manufacturing processes.
• Support the creation and execution of 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.
• Coordinate and work closely with Operations groups, suppliers, and Quality Assurance to resolve in-house and supplier quality problems using established problem-solving methodologies.
• Lead product transfers from outside vendors and other plants/facilities.
• Identify and manage cost reduction projects in support of goals.
• Define & implement specific solutions to technical problems, completing the tasks and writing reports that clearly document the results.
• Identify sources of waste in production and implement changes that drive cost, quality and delivery.

Qualifications

• Bachelor's Degree in Engineering, Mechanical/ Industrial Engineering, or equivalent. M.S. in Engineering or M.B.A. preferred.
• 10 years of Manufacturing or Operations Engineering experience in a manufacturing environment.
• Expertise in Lean, data analysis/interpretation and problem-solving tools with a high focus on process improvement.
• Demonstrated ability to consistently deliver high profile projects on-time with quality results.
• Experience with ISO quality systems and regulated manufacturing environments.
• Demonstrated use of risk management and quality tools such as failure modes and effects analysis and control plans.
• Ability to work in a team environment, provide leadership within a cross-functional project team and mentor junior engineers.
• Experience in defining requirements for manufacturing systems.
• Computer skills using Microsoft Office applications (Excel, Outlook, Teams, Word, PowerPoint, Project) and Minitab. Solidworks preferred.

Working conditions

Indoor, office setting, light industrial plant, some light background noise due to production operations.

Physical requirements

• Able to sit or stand for 8 to 10 hours; may occasionally lift up to 25 pounds.
• 20/20 corrected vision with the ability to differentiate colors.
• Ability to hear verbal instructions.
• Ability to occasionally lift up to 25 pounds.

Supervisory responsibility

None

AAP/EEO Statement

ZOLL is committed to fostering an inclusive workplace, where unique identities, backgrounds, cultures, perspectives and experiences are respected and valued.

Equal Opportunity Employer - Disability and Veteran

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.