Manufacturing Engineer

Job Title: Manufacturing Engineer Location: Mounds View, MN 95054 (Onsite)

Job Description:

We are seeking a skilled and detail-oriented Manufacturing Engineer to support and optimize production processes, ensure regulatory compliance, and coordinate supplier activities in a medical device manufacturing environment. This is an onsite role based in Mounds View, MN.

Key Responsibilities:

Review and approve critical production documents, including:

Control Plans

Process Flow Charts

Process Drawings

Capability Studies

Design Failure Mode and Effects Analysis (DFMEA)

Process Failure Mode and Effects Analysis (PFMEA)

Conduct and support risk assessments and root cause analysis for nonconformances and deviations.

Lead and participate in the Corrective and Preventive Actions (CAPA) process.

Perform Measurement System Analysis (MSA) and Test Method Validation (TMV) .

Prepare and review test protocols and test reports for production qualification.

Coordinate with suppliers for the qualification of new suppliers or changes to existing products and processes.

Support and review all phases of Process Validation (IQ/OQ/PQ) , MSA, and Control Plans.

Drive the Production Part Approval Process (PPAP) and route checklists using Agile .

Ensure compliance with Good Manufacturing Practices (GMP) and relevant industry regulations, including:

FDA QSR (21 CFR Part 820)

ISO 13485

ISO 14971

Identify and qualify critical components and perform receiving inspections.

Review and approve supplier documentation per company procedures.

Provide leadership in supplier management and engagement , including driving supplier activities and improvement initiatives.

Utilize systems such as TrackWise and MAP Agile for documentation and process management.

Required Skills & Experience:

Strong experience with CAPA, DFMEA, PFMEA, and TMV

Proficiency in process validation (IQ/OQ/PQ) and MSA

Knowledge of regulatory standards: QSR 21 CFR 820, ISO 13485, ISO 14971

Experience with PPAP processes and Agile documentation systems

Supplier coordination and leadership experience

Familiarity with TrackWise and MAP Agile systems

Excellent communication, problem-solving, and cross-functional collaboration skills