Manufacturing Engineer III

Pay Range: $40-$55/hr.

Description:
***Candidate has to be local to Minnesota
* Location: Maple Grove, MN
* Work Mode: Hybrid - In office - Tuesday, Wednesday Thursday
* Possible extension
*Interview will be onsite or teams.

*This project addresses a CAPA related to Client's requirement to properly link design risks and design outputs to manufacturing processes performed by external suppliers. In this role, the Supplier Engineer will work closely with the client design team to identify the key design outputs that are critical from a designintent perspective, then collaborate with Sustaining Supplier Engineering (SE) and Quality Engineering (QE) to gather existing process validation documentation from suppliers. The team will review these validation packages aProductst criteria developed from the design output list to determine whether each supplier meets Client's minimum requirements. When gaps are identified, the engineer will partner with both the supplier and client sustaining teams to remediate deficiencies, improve validation or documentation, and ensure alignment with client expectations. This evaluation and remediation cycle will be repeated across all applicable contract manufacturers until all required supplier processes have been fully addressed.

About the role: This Supplier Engineer (SE) will be responsible for the remediation activities identified by CAPA 7720 for Client's 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 Client team members and CM SFMD suppliers to execute deliverables according to business needs.
Responsibilities Include:
-Review, remediate, and approve CM SFMD suppliers process risk documentation (PFMEA) to newly defined criteria.
-Review, remediate, and approve CM SFMD suppliers process and inspection validations to Client's statistical requirements.
-Perform change management activities to remediate gaps found in CM SFMD Suppliers process risk documentation and process/inspection validations.
-Collaborate with CM SFMD suppliers and Client functional resources to complete all activities needed to approve suppliers process risk documentation and process/inspection validations to the newly defined criteria.
-In all actions, it 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.
What Were Looking For:
Required Qualifications:
-Bachelors degree in engineering
-1 2 years of experience in a manufacturing environment.
- Experience with installation qualifications (IQ), operational qualifications (OQ), performance qualification (PQ), and test method validation (TMV).
-Ability to travel up to 15% of the time (mostly domestic, could be international).

Preferred qualifications:
-Experience working with suppliers or in supply chain management.
-Experience working in the Medical Device Field.
-Excellent communication and project management skills.
-Strong bias for action and results oriented.
-Self-driven and self-motivated to learn and apply knowledge to produce results.
-Good understanding of statistical methods, six sigma methodologies, and problem-solving methodologies.

Quality Systems Duties and Responsibilities: Build Quality into all aspects of their work by maintaining compliance to all Quality System requirements.