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 Acute Care Technology division of ZOLL 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:
Support all activities relating to ZOLL Medical product production. This includes daily manufacturing support, process and yield improvement, quality and cost improvements, floor layout, New Product Introduction, process definition and documentation. This position is responsible for developing, implementing, and validating processes, procedures, and equipment to manufacture medical devices in full compliance with the company's quality system.  Apply Lean concepts to reduce waste and maximize efficiency.  Troubleshoot production issues.  

Essential Functions:

• Work closely with R&D engineers during the product design phase to ensure Design for Manufacturability requirements are considered and implemented. Understands the product design to implement and improve manufacturing processes.

• Develop and improve existing manufacturing methods, fixtures, and assembly aids.

• Specify, evaluate, select, and implement new equipment and fixtures.  Define equipment preventive maintenance and calibration requirements.

• Create verification and validation test protocols and reports including equipment IQ/OQ/PQ as required.

• Analyze and documents workflow. Works with Production Management and Industrial Engineers to layout equipment and workspace for maximum efficiency.

• Work with Supplier Quality Engineer and suppliers to address issues and to identify opportunities to reduce cost. 

• Troubleshoot production issues and implements appropriate solutions. Uses DOE techniques to characterize and improve processes and production yields.

• Disposition Non-Conformance Reports and Corrective and Preventive Actions as assigned.

• Develop and improve efficient and effective systems for capturing critical process metrics for all manufacturing operations.  Implement automated data collection where possible.  

• Monitor process and equipment performance and manage weekly meeting to review manufacturing and quality data.

• Able to write clear, concise, and visual work instructions.

• Train Operators on new or modified processes.

• Facilitate communication between all team members.

• Provide leadership, direction, and ownership in areas of manufacturing engineering and process development.

• Perform and document Process Failure Modes and Effects Analysis as needed.

• Comply with all policies and standards.

• Any other job responsibilities as assigned by management and subject to modification.

Skill Requirements:

• Project management experience demonstrating the ability to meet schedules and cost targets.

• Able to accept and product timely results on multiple concurrent projects of significant complexity.

• Experienced in creating and executing process validations.

• Experience with Design for Manufacturing (ADM), Design of Experiments (DOE) and product/process Failure Mode and Effects Analysis (FMEA)

• Background in product structure, BOMs, and MRP/ERP systems.

• Exposure to LEAN Manufacturing, and Six Sigma or other structured problem-solving process.

• Experienced in creating process flows, pFMEA and other operations support documentation.

• Proficient in the most common PC based applications (Word, Excel, Visio, PowerPoint, etc.).

• Possess effective verbal and written communication and interpersonal skills to interact with associates at all levels of the organization.

• Familiarity with ISO 13485

• Familiarity with FDA QSR documentation requirements a plus.

• Solid Works experience a plus 

• Experience in implementing automation a plus.

Required/ Preferred Education and Experience:

• Minimum of a bachelor’s degree in engineering (Industrial, Electrical, Mechanical) or other technical discipline or equivalent. BSEE preferred.

• Should have 5 years minimum of direct floor support experience in an electro-mechanical assembly and functional test environment.

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 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.

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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.