Sr. Manufacturing Engineer

Medtronic; Brooklyn Center (MN); On-site; USD 107,000 - 147,000; Full time

Job summary

An established industry player is seeking a Sr. Manufacturing Engineer to enhance automated manufacturing processes in a regulated environment. This role involves designing, evaluating, and improving manufacturing equipment while ensuring compliance with FDA and ISO standards. The ideal candidate will leverage their expertise in statistical analysis and equipment validation to resolve production issues and optimize processes. Join a forward-thinking company dedicated to innovation and quality in medical device manufacturing, where your contributions will directly impact product excellence and operational efficiency.

Benefits

Health Insurance

Dental Insurance

Vision Insurance

Tuition Reimbursement

Disability Leave

HSA

FSA

Qualifications

• 2+ years of experience in Manufacturing Engineering for medical devices.
• Experience with FDA regulations, ISO 13485, and GMP.

Responsibilities

• Complete equipment and process changes within an FDA regulated environment.
• Design and develop manufacturing tooling and fixtures.

Skills

Manufacturing Engineering

FDA Regulations

ISO 13485

GMP

Statistical Analysis

Process Validation

Electrical Controls

Pneumatics

PLC

Root Cause Analysis

Education

Master's Degree in Engineering

Bachelor's Degree in Engineering

Tools

Minitab

JMP

JDE

FACTORYworks

SPACE

TEMPO

Job description

We anticipate the application window for this opening will close on - 11 Jul 2025.

Position Description

Sr. Manufacturing Engineer for Medtronic, Inc located in Brooklyn Center, MN. Responsible for completing equipment and process changes within an FDA regulated environment, ISO 13485 & GMP. Design, evaluate, install, operate, maintain, and continuously improve automated manufacturing equipment, systems, or processes including electrical controls, pneumatics, and PLC. Handle installation, qualification, and validation (IQ/OQ/PQ) of manufacturing equipment and processes such as resistance spot welding, laser welding, anode/cathode fabrication, electrical testing. Perform statistical analysis including Gage R&R, ANOVA, Capability & Normality Assessments. Characterize manufacturing processes using Minitab/JMP, including DOE, SPC, hypothesis testing, regression modeling, and capability studies. Manage manufacturing systems like JDE, FACTORYworks, SPACE, and TEMPO. Design and develop manufacturing tooling and fixtures. Resolve production quality issues through root cause analysis, product disposition, and CAPA. Sustain and optimize the fabrication process of the Blackwell battery line to meet production, quality, and cost objectives. *Multiple positions available.*

Qualifications

Basic Qualifications: Master's Degree or foreign equivalent in Mechanical, Industrial, or Maintenance Engineering or related field. Requires two (2) years of experience in Manufacturing Engineering for medical devices, including experience in equipment and process changes, FDA regulated environment, ISO 13485 & GMP, automation, equipment validation, statistical analysis, manufacturing systems, CAD design, and quality issue resolution.

Alternate Qualifications: Bachelor's Degree or foreign equivalent with four (4) years of relevant experience in similar areas.

Additional Details

Worksite location: 6800 Shingle Creek Parkway, Brooklyn Center, MN 55430.

Salary: $107,800 to $146,400 per year.

This position qualifies for Medtronic's employee referral bonus program at $1,000. Benefits include health, dental, vision, HSA, FSA, life insurance, disability leave, tuition reimbursement, and more. Further details available at the provided link.

Medtronic is committed to diversity and equal employment opportunity, with various initiatives and policies supporting a diverse, inclusive workplace.