Senior Manufacturing Process Engineer

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 Medical Corporation 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

The position is responsible for developing, implementing, and validating processes and procedures to manufacture electromechanical and catheter-based medical devices in full compliance with the company's quality system. Apply Lean concepts to reduce waste and maximize efficiency. Troubleshoot production issues. Work with vendors to drive cost reductions to existing components and assemblies

Essential Functions

• Develop and maintain a good working knowledge of general product development process, current and next generation project activities, and basic technical and clinical fundamentals of the products.
• Drive the development, documentation, prototyping, testing, validation and implementation of new/improved manufacturing processes.
• Perform various test functions on devices/equipment and provide meaningful analysis/interpretation of data.
• Create and release documentation to support production, Assembly Procedures, Lot History Records, Manufacturing Specifications, Work Instructions, Parts Lists, etc. Provide appropriate detail in change request justifications and ensure all necessary reference documentation exists and is audit ready.
• Support IQ's, OQ's and PQ's when introducing new or changing existing manufacturing equipmen
• Works with vendors to address issues and to identify opportunities to reduce cost. Coordinates efforts with Supplier Quality Engineer.
• Comply with all policies and standards.
• Provides leadership, direction, and ownership in areas of manufacturing engineering and process development.
• Any other job responsibilities as assigned by management and subject to modification.

Required/Preferred Education and Experience

• B.S. in Mechanical Engineering.

• 5-9 years manufacturing engineering experience, preferably in a regulated environment

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

• Solid Works experience a plus.

• Plastic injection molding experience is a plus.

• Medical device manufacturing involving electromechanical and/or catheter-based products (preferred).

• Lean methodologies, FDA, ISO.

Knowledge, Skills and Abilities

• Solid background in mechanical, and/or materials engineering

• Able to use Solid Works to document fixtures and assembly aids

• Knowledge of Statistical software (Minitab, JMP, etc)

• Able to collaborate effectively in cross-functional teams

• A positive and enthusiastic attitude towards learning, problem solving, and working with a diverse range of functions within the organization

• Strong time management skills with an emphasis on managing multiple projects simultaneously.

• Writes clearly and informatively; varies writing style to meet needs; presents numerical data effectively; Knowledge of Microsoft Office Products (Word, Excel, Powerpoint, etc)

• Demonstrates accuracy and thoroughness; applies feedback to improve performance.

• Demonstrates strong attention to detail; monitors own work to ensure quality.

• Microscope and measurement equipment familiarity

• Familiarity with tools and/or machine shop equipment

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' 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.

The salary range for this position can range from $135,000 to $168,000 per year. The actual compensation may vary outside of this range depending on geographic location, work experience, education, and skill level.

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.