Sr Process Development Engineer (Hybrid)- Irvine, CA

Medtronic; Santa Ana (CA); Hybrid; USD 130,000 - 196,000; Full time

Job summary

A leading company in healthcare technology is seeking a Senior Process Development Engineer to lead the development of manufacturing processes for new products. This hybrid role requires expertise in engineering, collaboration with teams, and a focus on regulatory compliance. The position involves designing efficient manufacturing workflows and optimizing processes while ensuring high quality and cost-effectiveness. Candidates should have significant engineering experience and a Bachelor's degree in a relevant field.

Benefits

Health Insurance

Dental Insurance

Vision Insurance

Retirement Plans

Qualifications

• 7+ years of engineering experience or 5+ years with an advanced degree.

Responsibilities

• Design and optimize laser-based manufacturing processes.
• Develop and maintain manufacturing documentation.
• Collaborate with product development teams.

Skills

Six Sigma

Statistical Tools

Collaboration

Education

Bachelor’s degree in Engineering

Tools

DOE

SPC

Job description

Sr Process Development Engineer (Hybrid)- Irvine, CA

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Position Overview

The Senior Process Development Engineer will lead the development of manufacturing processes for new products within the Peripheral Vascular Health (PVH) business. Responsibilities include designing and optimizing manufacturing processes, supporting new product development, and ensuring regulatory compliance. This role requires collaboration with cross-functional teams and may involve domestic and international travel.

Key Responsibilities

• Design and optimize laser-based manufacturing processes, oversee laser-cut parts production, and develop new laser-based methods.
• Procure and develop complex capital equipment.
• Support new product development by designing manufacturing processes that are efficient, cost-effective, and yield high quality.
• Design manufacturing workflows and specifications for pilot line development.
• Conduct feasibility studies on new process technologies and evaluate their application.
• Identify and develop equipment and fixtures, working with suppliers and internal teams.
• Generate qualification and validation plans, perform tests, and apply Six Sigma methodologies.
• Develop and maintain manufacturing documentation, including protocols, reports, and procedures.
• Collaborate with product development teams to ensure manufacturability and quality.
• Develop cost-benefit analyses and implement process improvements.
• Travel up to 10% domestically and internationally.

Minimum Requirements

• Bachelor’s degree in Engineering or a technical discipline.
• 7+ years of engineering experience or 5+ years with an advanced degree.

Preferred Qualifications

• Experience in medical device manufacturing or regulated environments.
• Knowledge of new product development processes.
• Proficiency with statistical tools such as DOE, SPC, and Process Capability Studies.
• Experience with polymer extrusion, thermal bonding, adhesive bonding, or laser processing.
• Six Sigma training/certification.

Physical and Other Requirements

Must meet physical demands typical of engineering roles, including mobility and communication requirements. Reasonable accommodations can be provided.

Benefits & Compensation

Competitive salary ($130,400 - $195,600), incentive plans, comprehensive benefits including health, dental, vision, retirement plans, and more. Details vary by location and employment status.

About Medtronic

Medtronic is a global leader in healthcare technology committed to innovation and improving patient outcomes. We value diversity, inclusion, and equal opportunity employment.