Senior Manufacturing Process Engineer

ZOLL Medical Corporation; San Jose (CA); On-site; USD 80,000 - 120,000; Full time

Job summary

ZOLL Medical Corporation is seeking an Electrical Engineer to enhance medical device manufacturing processes. The role involves process development, quality documentation, and thorough troubleshooting, ensuring compliance with quality systems. Ideal candidates will have a degree in Electrical Engineering and experience in project management within the medical sector.

Qualifications

• 5-9 years of Electrical Engineering experience required.
• Strong understanding of Electrical Engineering Fundamentals.
• Experience designing and troubleshooting with Electrical Equipment.

Responsibilities

• Develop processes for manufacturing electromechanical medical devices.
• Drive documentation for manufacturing specifications.
• Troubleshoot production issues and support equipment validation.

Skills

Circuit Design

Circuit Analysis

Troubleshooting

Project Management

Data Analysis

Attention to Detail

Problem Solving

Education

Bachelor's Degree in Electrical Engineering

Tools

Oscilloscopes

Power Supplies

DMMs

PCB Layout tools

Microsoft Office Products

Statistical software (Minitab, JMP)

Job description

Acute Care Technology

see attached document

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 Circulation division of ZOLL Medical Corporation is focused on "beating heart" therapies for hospitals. Post-cardiac arrest, STEMI heart attack, and severe fever are some of the applications of ZOLL's unique devices. Fully integrated, ZOLL Circulation researches, develops, manufactures, and sells novel technologies including ZOLL Temperature Management Solutions and TherOx SSO2 Therapy. Temperature Management Solutions empower physicians to "prescribe" a temperature and achieve it. TherOx 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.

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

1. 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.
2. Drive the development, documentation, prototyping, testing, validation, and implementation of new/improved manufacturing processes.
3. Perform various test functions on devices/equipment and provide meaningful analysis/interpretation of data.
4. 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.
5. Support IQ’s, OQ’s, and PQ’s when introducing new or changing existing manufacturing equipment.

Required/Preferred Education and Experience

1. Bachelor's Degree in Electrical Engineering preferred.
2. 5-9 years of Electrical Engineering experience.

Knowledge, Skills, and Abilities

1. A positive and enthusiastic attitude towards learning, problem solving, and working with a diverse range of functions within the organization.
2. Strong understanding of Electrical Engineering Fundamentals, Circuit Design, Circuit Analysis.
3. Experience troubleshooting with Electrical Equipment (Oscilloscopes, Power Supplies, DMMs, etc).
4. Capable of designing schematics using PCB Layout tools (Mentor Graphics Pads, OrCAD, Altium, etc).
5. Demonstrates the ability to work well with hardware and software (C++, Labview, etc).
6. Strong time management skills with an emphasis on managing multiple projects simultaneously.
7. Writes clearly and informatively; varies writing style to meet needs; presents numerical data effectively; Knowledge of Microsoft Office Products (Word, Excel, PowerPoint, etc).
8. Demonstrates accuracy and thoroughness; applies feedback to improve performance.
9. Demonstrates strong attention to detail; monitors own work to ensure quality.
10. Microscope and measurement equipment familiarity.
11. Familiarity with tools and/or machine shop equipment.
12. Knowledge of Statistical software (Minitab, JMP, etc).

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.

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.