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Sr. Manufacturing Engineer - Medical Device

LCI-Lawinger ConsultingFridley, MN

$55 - $75 / hour

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Overview

Education
Engineering (PE)
Career level
Senior-level
Remote
On-site
Compensation
$55-$75/hour
Benefits
Career Development

Job Description

Senior Manufacturing Engineer – Medical Device Manufacturing

Contract 4-6 mos. (with potential for direct hire)Location: Fridley, MNCompensation: $55-$75/hr.Position Summary

The Senior Manufacturing Engineer is responsible for developing, optimizing, and sustaining manufacturing processes for medical device production. This role drives process improvements. ensures compliance with quality and regulatory requirements.

Key Responsibilities

  • Develop, validate, and optimize manufacturing processes and equipment.

  • Lead process improvement initiatives using Lean, Six Sigma, and root cause analysis.

  • Support new product introduction through process development, qualification, and transfer to production.

  • Create and maintain manufacturing documentation, including work instructions, PFMEAs, control plans, and process validations (IQ/OQ/PQ).

  • Investigate and resolve production issues using data-driven problem-solving methods.

  • Collaborate with Quality, R&D, Supply Chain, and Operations to improve product manufacturability and operational performance.

  • Ensure compliance with FDA, ISO 13485, GMP, and company quality system requirements.

  • Mentor junior engineers and provide technical leadership on manufacturing projects.

Qualifications

  • Bachelor's degree in Mechanical, Manufacturing, Industrial, Biomedical, or related Engineering field.

  • 5-7 years of manufacturing engineering experience, preferably in the medical device industry.

  • Experience with process validation, Lean manufacturing, statistical analysis, and continuous improvement.

  • Working knowledge of FDA regulations, ISO 13485, GMP, and risk management tools.

  • Strong problem-solving, project management, and communication skills.

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FAQs About Sr. Manufacturing Engineer - Medical Device Jobs at LCI-Lawinger Consulting

What is the work location for this position at LCI-Lawinger Consulting?
This job at LCI-Lawinger Consulting is located in Fridley, MN, according to the details provided by the employer. Some roles may also include multiple work locations depending on the requirement.
What pay range can candidates expect for this role at LCI-Lawinger Consulting?
Candidates can expect a pay range of $55–$75 per hour for this role.
What employment applies to this position at LCI-Lawinger Consulting?
The employer has not provided this information. This may be discussed during the hiring process.
What experience level is required for this role at LCI-Lawinger Consulting?
LCI-Lawinger Consulting is looking for a candidate with "Senior-level" experience level.
What education level is required for this job?
The education requirement for this position is Engineering (PE). Candidates with relevant qualifications or equivalent experience may also be considered.
What benefits are offered by LCI-Lawinger Consulting for this role?
LCI-Lawinger Consulting offers Career Development for this position. Actual benefits may vary depending on the employer's policies and employment terms.
What is the process to apply for this position at LCI-Lawinger Consulting?
You can apply for this role at LCI-Lawinger Consulting either through Sonara's automated application system, which helps you submit applications 10X faster with minimal effort, or by applying manually using the direct link on the job page.