Manufacturing Engineer

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.