Job Title: Manufacturing Operations Engineer

Duration: 12+ Months (Possible temp to hire)

Location: Maple Grove, MN 55311

Hybrid Role

Responsibilities:

Looking for candidate with more operational experience than design experience.
Will be working closely with a lot of individuals and work with 10 - 20 contract manufacturers.
MUST have good communications skills. Cannot be afraid to "pick up the phone"
This project addresses a CAPA related to requirement to properly link design risks and design outputs to manufacturing processes performed by external suppliers.
Will work closely with the design team to identify the key design outputs that are critical from a design‑intent 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 against criteria developed from the design output list to determine whether each supplier meets BSC’s minimum requirements.
When gaps are identified, the engineer will partner with both the supplier and sustaining teams to remediate deficiencies, improve validation or documentation, and ensure alignment with BSC expectations.
This evaluation and remediation cycle will be repeated across all applicable contract manufacturers until all required supplier processes have been fully addressed.
This Supplier Engineer (SE) will be responsible for the remediation activities identified by CAPA 7720 for contract manufactured (CM) sourced finished medical device (SFMD) product.
Review, remediate, and approve CM SFMD supplier’s process risk documentation (PFMEA) to newly defined criteria.
Perform change management activities to remediate gaps found in CM SFMD Supplier’s process risk documentation and process/inspection validations.
Collaborate with 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:

Bachelor’s 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:

Experience working with suppliers or in supply chain management.
Experience working in the Medical Device Field.
Excellent communication and project management skills.
Good understanding of statistical methods, six sigma methodologies, and problem-solving methodologies.

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