Manufacturing Engineer

Job Description:

We are seeking a Manufacturing Engineer with at least 2 years of experience in a regulated manufacturing environment, preferably within the medical device industry, to support and enhance manufacturing operations with a strong focus on process validation planning and execution. This role is ideal for an engineer who already has hands-on validation experience and wants to deepen their expertise in medical device process validation while contributing to process development, improvement, and manufacturing scale-up.

Responsibilities:

* Support and execute process validation activities in compliance with FDA regulations and internal quality requirements.

* Participate in validation planning by assisting with strategy development, risk assessments, protocol drafting, and planning reviews.

* Support and execute validation activities, including IQ/OQ/PQ, data collection, data analysis, and preparation of validation reports.

* Provide a technical perspective during validation planning by reviewing assumptions, approaches, and documentation to ensure robustness and compliance.

* Apply experience from various validation requirements and manufacturing scenarios to strengthen validation strategies and execution.

* Assist in planning, executing, and documenting Test Method Validation (TMV) activities to ensure methods are suitable and reliable.

* Ensure test methods are repeatable, reproducible, and aligned with regulatory expectations.

* Support process development and continuous improvement initiatives across manufacturing operations.

* Assist in identifying opportunities to improve process capability, efficiency, and overall manufacturing flow.

* Apply Lean manufacturing principles or similar methodologies to improve throughput and reduce waste.

* Assist with manufacturing scale-up activities, including manufacturing flow optimization, capacity analysis, and maximum output and throughput projections.

* Support readiness for increased production volumes and commercialization of products.

* Work closely with Manufacturing, Quality, and Engineering teams to execute validation and improvement projects.

* Collaborate with more engineers as a thought partner, incorporating feedback to strengthen planning and execution.

* Contribute as an additional reviewer for validation planning and documentation to help ensure quality, completeness, and compliance.

* Prepare clear, accurate technical documentation and perform data analysis to support engineering decisions and regulatory requirements.

Essential

Skills:

* At least 2 years of experience in manufacturing engineering within a regulated industry, preferably medical devices.

* Hands-on experience supporting process validation activities, including planning and execution.

* Experience with process validation planning and execution, including IQ/OQ/PQ.

* Exposure to Test Method Validation (TMV).

* Familiarity with Lean manufacturing concepts and manufacturing flow.

* Ability to support manufacturing process scale-up, including capacity analysis and throughput projections.

* Strong technical documentation skills with the ability to write clear protocols, reports, and supporting documentation.

* Solid data analysis skills to interpret validation and process data and support decision-making.

* Collaborative mindset with the ability to work effectively with cross-functional teams in Manufacturing, Quality, and Engineering.

Additional Skills &

Qualifications:

* Bachelor's degree in Engineering, such as Manufacturing, Mechanical, Biomedical, or a related field.

* Experience in a medical device manufacturing environment or other highly regulated industries.

* Experience applying Lean manufacturing principles or similar continuous improvement methodologies.

* Ability to identify and implement process improvements to enhance capability, efficiency, and flow.

* Interest in building deep expertise in medical device process validation, including both planning and execution.

* Desire to learn and grow within a regulated environment, leveraging mentoring from experienced engineers.

* Strong attention to detail and a quality-focused approach to validation and documentation.

* Ability to serve as an additional technical reviewer to help ensure validation plans and documents meet regulatory and internal standards.

Job Type & Location

This is a Contract to Hire position based out of White Bear Lake, MN.

Pay and Benefits

The pay range for this position is $40.00 - $52.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

* Medical, dental & vision

* Critical Illness, Accident, and Hospital

* 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available

* Life Insurance (Voluntary Life & AD&D for the employee and dependents)

* Short and long-term disability

* Health…