NPI & Manufacturing Engineer – Medical Devices (FDA-regulated)

Spiro Robotics; Hayward (CA); Vor Ort; USD 120.000 - 150.000; Vollzeit

Zusammenfassung

Spiro Robotics is seeking a Manufacturing Engineer to drive NPI, line transfer, and process validation as we scale from development to commercial-grade production of FDA Class II devices.

The role collaborates with international contract manufacturers, ensuring compliant, scalable processes and effective technology transfer, DFMA improvements, and robust validation protocols on a fast-paced team.

Qualifikationen

• 5+ years in the medical device manufacturing/engineering field, Class II experience preferred.
• Bachelor’s or Master’s degree in Mechanical/Manufacturing/Biomedical Engineering or related field.
• Proven experience leading NPI transfers to external contract manufacturers.
• Strong understanding of 21 CFR Part 820, ISO 13485, Design Controls.
• Willingness to travel internationally up to 30% during peak transfer phases.

Aufgaben

• Lead end-to-end NPI and sustaining manufacturing engineering activities, including technology transfer from R&D to production.
• Serve as the technical lead and primary manufacturing interface with international contract manufacturing partners.
• Develop and execute manufacturing strategies aligned with Design Controls, QMS, ISO 13485, and commercialization timelines.
• Lead DFMA initiatives to improve product yield, throughput, and cost of goods sold.
• Support change control, supplier qualification, quality agreements, and manufacturing readiness activities.
• Lead transfer of single-use disposable devices and electromechanical systems to contract manufacturers in Germany.

Kenntnisse

Manufacturing engineering

Process engineering

NPI transfers

Statistical methods

IQ/OQ/PQ testing

Cross-functional communication

Travel internationally

Ausbildung

Bachelor’s or Master’s in Mechanical/Manufacturing/Biomedical Engineering

Tools

Arena

eQMS

Jobbeschreibung

Spiro Robotics is seeking a Manufacturing Engineer to drive NPI, line transfer, and process validation as we scale from development to commercial-grade production of FDA Class II devices.

The role collaborates with international contract manufacturers, ensuring compliant, scalable processes and effective technology transfer, DFMA improvements, and robust validation protocols on a fast-paced team.