Senior Ops Quality Engineer, Med Device — Equity

Neptune Medical; Burlingame (CA); Sur place; USD 150 000 - 190 000; Plein temps

Avantages offerts par ce poste

Equity

401(k) with matching

Health benefits

Résumé du poste

Neptune Medical is a Burlingame, CA-based medical device startup hiring a Sr. Operations Quality Engineer to support volume production, new product introductions, and continuous improvements for assembly processes.

You will collaborate with production, quality control, and cross-functional teams to improve efficiency, reduce costs, and ensure GMP/GDP and FDA QMSR compliance. The role blends leadership with hands-on quality engineering, mentoring staff, and driving data-driven decisions using

Qualifications

• Bachelor's degree in Manufacturing, Biomedical or Mechanical Engineering; Master’s preferred.
• 5–7 years of professional engineering experience in medical devices.
• Strong knowledge of GMP, GDP, ISO 13485 and related regulations.
• Proficiency with statistical software for design and process optimization.

Responsabilités

• Lead quality improvements, cost reduction, and production scaling initiatives.
• Author and maintain inspection docs, QIPs, WIs and test methods.
• Provide technical quality support to production, including sterilization validation.
• Lead NCR/CAPA, root-cause analysis, and cross-functional collaboration.

Connaissances

Leadership

Analytical thinking

Communication

Problem solving

Cross-functional collaboration

Statistical analysis

Formation

Bachelor's degree in Manufacturing Engineering

Master's degree preferred

Outils

Minitab

JMP

EDMS

ERP systems

Description du poste

Neptune Medical is a Burlingame, CA-based medical device startup hiring a Sr. Operations Quality Engineer to support volume production, new product introductions, and continuous improvements for assembly processes.

You will collaborate with production, quality control, and cross-functional teams to improve efficiency, reduce costs, and ensure GMP/GDP and FDA QMSR compliance. The role blends leadership with hands-on quality engineering, mentoring staff, and driving data-driven decisions using