Senior Manufacturing Engineer – Medical Devices

Medtronic; Irvine (CA); On-site; USD 102,000 - 154,000; Full time

Job summary

Medtronic in Irvine, CA is seeking a Senior Manufacturing Engineer to design, optimize, and sustain high‑performance medical device manufacturing processes in a regulated environment. You will lead cross‑functional efforts with Operations, Quality, R&D, Sourcing, and Packaging to support product lifecycle needs and drive KPI improvements such as yield and OEE.

You will mentor junior engineers, apply lean manufacturing and DOE/ SPC methodologies, and ensure compliance with regulatory requirements

Qualifications

• Requires a Bachelor's degree and 4+ years of relevant experience, or Master's degree with 2+ years relevant experience, or PhD with 0 years relevant experience.
• Strong lean manufacturing and problem-solving skills with experience in design of experiments (DOE) and SPC.
• Experience leading validation strategies and cross-functional partnerships to meet regulatory and performance goals.

Responsibilities

• Designs manufacturing processes, procedures and production layouts for assemblies, equipment installation, processing, machining and material handling.
• Designs arrangement of machines within plant facilities to ensure most efficient and productive layout.
• Develops manufacturing processes applicable to statistical process control and validation activities.
• Provides guidance to engineering regarding design concepts and specification requirements to best utilize equipment and manufacturing techniques.
• Ensures processes and procedures are in compliance with regulations.

Skills

Lean manufacturing

DOE design

Statistical process control

MPS methodologies

Cross-functional collaboration

Regulatory compliance

Education

Bachelor's degree in a relevant field

Master's degree

PhD

Job description

Medtronic in Irvine, CA is seeking a Senior Manufacturing Engineer to design, optimize, and sustain high‑performance medical device manufacturing processes in a regulated environment. You will lead cross‑functional efforts with Operations, Quality, R&D, Sourcing, and Packaging to support product lifecycle needs and drive KPI improvements such as yield and OEE.

You will mentor junior engineers, apply lean manufacturing and DOE/ SPC methodologies, and ensure compliance with regulatory requirements