Staff Manufacturing Engineer

Location: Pittsburgh, PA, United States of America

Cardiac Management Solutions

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
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.
Duties and responsibilities

• Serve as manufacturing lead to support new product development teams, ensuring a successful transfer of design into production.

• Critically assess 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, manage, and communicate project schedules across a cross-functional team as required.
• Actively participate and/or lead teams in the development and improvement of the manufacturing process 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 sustaining changes at remote distribution and service facilities.
• Work closely with Operations groups, suppliers, and Quality Assurance to resolve in-house and supplier quality problems using established problem-solving methodologies.
• Support 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.
• Review & approve inspection plans, routers and product drawings.
• Identify sources of waste in production and implement changes that drive cost, quality and delivery.
• Identify and implement ergonomic improvements.
• Bachelor's Degree in Engineering, Mechanical/ Industrial Engineering, or equivalent
• 7+ years of Operations Engineering experience in a manufacturing environment.
• Demonstrated ability to deliver on high profile projects and effectively communicate project status.
• 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.
• Demonstrated proficiency in Lean and problem-solving tools with a high focus on process improvement – preferred.
• Experience in defining requirements for manufacturing systems.
• Computer skills using Microsoft Office applications (Excel, Outlook, Teams, Word, PowerPoint, Project). Minitab and 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
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