Principal Manufacturing Engineer- Onsite

Medtronic; Irvine (CA); On-site; USD 90,000 - 140,000; Full time

Job summary

Join a forward-thinking company as a Principal Manufacturing Engineer, where you will be pivotal in optimizing manufacturing processes and ensuring quality in medical device production. In this role, you will leverage your extensive experience to lead projects that enhance efficiency and compliance. Collaborate with a diverse team to solve complex challenges and drive innovation in healthcare technology. This is an exciting opportunity to make a significant impact in a dynamic environment focused on improving patient outcomes and advancing healthcare access for all.

Benefits

Competitive Salary

Health Benefits

Retirement Plans

Professional Development Opportunities

Flexible Work Arrangements

Qualifications

• 7+ years of medical device manufacturing engineering experience.
• Proficient in Lean/Six Sigma tools and process validation.

Responsibilities

• Lead manufacturing operations oversight and process improvements.
• Support quality control measures and compliance with standards.

Skills

Project Management

Validation Procedures

Lean/Six Sigma

Troubleshooting Skills

Technical Writing

Statistical Skills

Education

Bachelor’s Degree

Tools

Quality Control Software

Statistical Analysis Software

Job description

We anticipate the application window for this opening will close on - 12 May 2025.

At Medtronic, you can begin a lifelong career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.

A Day in the Life

At Medtronic, we push the limits of what technology can do to make tomorrow better than yesterday. We value what makes you unique. Be part of a company that thinks differently to solve problems, make progress, and deliver meaningful innovations.

The Principal Manufacturing Engineer will join the NV GOSC team, focusing on supporting sustaining optimization projects and qualifications. Responsibilities include project management, validation procedures, manufacturing instructions, executing validations, report compilation, task coordination, and engineering change orders. The role interacts with manufacturing operators, quality engineers, and design engineers to ensure proper qualification plans are followed.

Principal Manufacturing Engineer

Location: Onsite, Irvine, California

Responsibilities may include the following and other duties may be assigned:

• Support production engineering regarding testing methods, procedures, and problem-solving; device specifications and yield issues; minor redesigns; customer returns analysis; supplier engineering changes; and cost optimization.
• Oversee device and component transfer into high-volume production, managing manufacturing operations beyond wafer fabrication.
• Assist with device usage problems or testing of complex devices.

Key Accountabilities:

• Lead manufacturing operations oversight and upstream/downstream processes.
• Serve as the primary manufacturing contact for the engineering support team.
• Support quality control measures to ensure compliance with standards.
• Lead process improvements to enhance quality and efficiency.
• Conduct risk assessments to ensure safety and efficacy.
• Stay current with regulatory standards and ensure compliance.
• Act as the primary MDR contact, with potential to assume the quality program manager role.
• Collaborate with suppliers to improve incoming component quality.
• Lead root cause analyses and corrective actions for quality issues.
• Maintain documentation for GMP compliance.
• Train manufacturing personnel on quality procedures.
• Support audits, including FDA inspections.
• Oversee product testing, validation, and verification.
• Mentor junior engineers and support IP strategy development.

Must Have: Minimum Requirements

• Bachelor’s degree required.
• At least 7 years of relevant medical device manufacturing engineering experience, or 5 years with an advanced degree.

Nice to Have:

• Experience with Lean/Six Sigma tools, equipment development, process validation (IQ/OQ/PQ), and small tooling design.
• Engineering experience with medical devices, troubleshooting skills, DOE, technical writing, statistical skills, and proficiency in relevant software.
• Knowledge of project management, budgets, and regulation compliance.

Physical Job Requirements

Details about physical demands and accommodations for disabilities.

Benefits & Compensation

Competitive salary, benefits, and incentives, with specific details on compensation ranges and offered benefits.

About Medtronic

Global leader in healthcare technology committed to innovation and diversity. Learn more about our mission and values here.

Medtronic is an equal opportunity employer providing accommodations for individuals with disabilities.