Senior Medical Device Supplier Engineer – Hybrid

Apex Systems; Maple Grove (MN); Hybride; USD 73 000 - 76 000; Plein temps

Résumé du poste

Apex Systems is seeking a Supplier Engineer III hybrid role for a 12-month project. The role focuses on remediation activities for CM SFMD products, leading SE remediation tasks and coordinating with suppliers and internal teams.

Emphasis on quality, CAPA 7720, PFMEA, and validations to defined criteria. Requirements include a Bachelor’s degree in engineering, 2–5 years manufacturing experience, and travel up to 15%.

Qualifications

• Bachelor’s degree in engineering required.
• 2–5 years in a manufacturing setting.
• Willing to travel up to 15% (domestic).
• Experience with CAPA remediation and SFMD is a plus.
• Strong communication and project management skills.

Responsabilités

• Review and approve PFMEA to new criteria.
• Review and approve validations to statistical requirements.
• Perform change management to remediate gaps.
• Collaborate with CM SFMD suppliers and BSC resources.
• Demonstrate commitment to patient safety and quality.

Connaissances

Problem solving

Mfg. experience

Validation experience

Change management

Formation

Bachelor's degree in engineering

Outils

IQ/OQ/PQ/TMV

Description du poste

Apex Systems is seeking a Supplier Engineer III hybrid role for a 12-month project. The role focuses on remediation activities for CM SFMD products, leading SE remediation tasks and coordinating with suppliers and internal teams.

Emphasis on quality, CAPA 7720, PFMEA, and validations to defined criteria. Requirements include a Bachelor’s degree in engineering, 2–5 years manufacturing experience, and travel up to 15%.