NPI Manufacturing Engineer - Medical Devices

Spiro Robotics; Hayward (CA); On-site; USD 64,000 - 90,000; Full time

Job summary

Spiro Robotics is seeking a Junior Manufacturing Engineer to help scale manufacturing from pre-commercial development to commercial production. You will support NPI, line transfer, and process validation for FDA Class II devices, collaborating with global contract manufacturers to ensure robust, compliant production.

You will contribute to DFMA, process development, and manufacturing readiness, while supporting supplier quality and continuous improvement across the manufacturing network.

Qualifications

• Bachelor’s or Master’s degree in Mechanical, Manufacturing, Biomedical Engineering or related field.
• Experience leading NPI transfers to external contract manufacturers.
• Knowledge of 21 CFR Part 820 and ISO 13485 quality systems.
• Experience writing IQ/OQ/PQ protocols in regulated medical device environments.

Responsibilities

• Support NPI and sustaining manufacturing engineering activities, including tech transfer from R&D to production.
• Interface with international contract manufacturing partners.
• Develop manufacturing strategies aligned with Design Controls and QSR timelines.
• Perform DFMA initiatives to improve yield, throughput, and COGS.
• Support change control, supplier qualification, quality agreements, and manufacturing readiness.

Skills

NPI transfers

Statistical methods

IQ/OQ/PQ protocols

Regulatory knowledge

FDA audits

Root cause analysis

Cross-functional communication

Travel willingness

Education

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

Job description

Spiro Robotics is seeking a Junior Manufacturing Engineer to help scale manufacturing from pre-commercial development to commercial production. You will support NPI, line transfer, and process validation for FDA Class II devices, collaborating with global contract manufacturers to ensure robust, compliant production.

You will contribute to DFMA, process development, and manufacturing readiness, while supporting supplier quality and continuous improvement across the manufacturing network.