Supplier Manufacturing Engineer

REQ Solutions; Maple Grove (MN); Hybrid; USD 70,000 - 95,000; Full time

Job summary

REQ Solutions is seeking a Supplier Manufacturing Engineer for a 12+ month hybrid role in Maple Grove, MN 55311. The position focuses on remediation activities for CM SFMD products and cross-functional collaboration with suppliers.

You will review PFMEA and process validations, perform change management, and ensure compliance with quality standards. Ideal candidates have 2–5 years in manufacturing, strong problem solving, supplier experience, and willingness to travel up to 15%.

Qualifications

• 2-5 years of experience in a manufacturing environment.
• Strong problem solving skills with demonstrable examples.
• Ability to travel up to 15% (domestic).
• Experience with supplier or supply chain management (preferred).

Responsibilities

• Supplier Engineer (SE) will be responsible for the remediation activities identified by CAPA 7720 for contract manufactured (CM) sourced finished medical device (SFMD) product.
• This individual works independently, serves as a leader for SE remediation activities, and interacts cross-functionally with team members and CM SFMD suppliers to execute deliverables according to business needs.
• Review, remediate, and approve CM SFMD supplier’s process risk documentation (PFMEA) to newly defined criteria.
• Review, remediate, and approve CM SFMD supplier’s process and inspection validations to statistical requirements.
• Perform change management activities to remediate gaps found in CM SFMD Supplier’s process risk documentation and process/inspection validations.
• Collaborate with CM SFMD suppliers and functional resources to complete all activities needed to approve supplier’s process risk documentation and process/inspection validations to the newly defined criteria.
• Demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.

Skills

Problem solving

Manufacturing experience

Travel readiness

Communication skills

Project management

Tools

IQ

OQ

PQ

TMV

Job description

Job Title: Supplier Manufacturing Engineer

Duration: 12+ Months (Possible temp to hire)

Location: Maple Grove, MN 55311

Hybrid Role

Responsibilities:

• Supplier Engineer (SE) will be responsible for the remediation activities identified by CAPA 7720 for contract manufactured (CM) sourced finished medical device (SFMD) product.
• This individual works independently, serves as a leader for SE remediation activities, and interacts cross-functionally with team members and CM SFMD suppliers to execute deliverables according to business needs.
• Review, remediate, and approve CM SFMD supplier’s process risk documentation (PFMEA) to newly defined criteria.
• Review, remediate, and approve CM SFMD supplier’s process and inspection validations to statistical requirements.
• Perform change management activities to remediate gaps found in CM SFMD Supplier’s process risk documentation and process/inspection validations.
• Collaborate with CM SFMD suppliers and functional resources to complete all activities needed to approve supplier’s process risk documentation and process/inspection validations to the newly defined criteria.
• Demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.

Education/Experience:

• 2-5 years of experience in a manufacturing environment.
• Problem solving, being able to showcase examples
• Manufacturing experience
• Ability to travel up to 15% of the time. (Domestic possible.)

Preferred qualifications:

• Experience working with suppliers or in supply chain management.
• Experience working in the Medical Device Field.
• Experience with installation qualifications (IQ), operational qualifications (OQ), performance qualification (PQ), and test method validation (TMV).
• Excellent communication and project management skills.