Manufacturing Engineer: Lean & NPI Leader

Ascential Technologies; San Diego (CA); On-site; USD 90,000 - 110,000; Full time

Job summary

Ascential Medical and Life Sciences is seeking a Manufacturing Engineer to lead process development, validation, and continual improvement for regulated medical instruments. The role emphasizes lean practices, built‑in quality, and NPI ownership across cross‑functional teams in a high‑mix environment.

The candidate will drive CAPA, document control, and regulatory compliance (ISO 13485, FDA 21 CFR 820) while mentoring junior staff and collaborating with R&D, QA, and production to ensure

Qualifications

• Typically requires 2+ years of experience and a Bachelor’s degree in mechanical, electrical or industrial engineering.
• Knowledge of regulatory practices: FDA 21 CFR 820 and ISO 13485.
• Experience with PFMEA, control plans, process validation (IQ/OQ/PQ).
• Ability to lead NPI activities and client engagements.

Responsibilities

• Develop, validate, and implement robust assembly and test processes.
• Apply 5S, line design, and poka‑yoke to reduce waste and defects.
• Lead Kaizen and CAPA investigations to drive improvements.
• Own documentation, ECO/DCO changes, and change control processes.
• Collaborate cross‑functionally with Quality, Planning, and Production.
• Provide mentorship and track engineering and production metrics.

Skills

Lean manufacturing

Built-in Quality

5S

Single-piece flow

Poka-yoke

Value stream mapping

Standard work

Visual management

Root cause analysis

CAPA

Cross-functional collaboration

Mentorship

Education

Bachelor’s degree in mechanical, electrical or industrial engineering

Tools

SolidWorks

ERP systems

MS Office

CAD

Job description

Ascential Medical and Life Sciences is seeking a Manufacturing Engineer to lead process development, validation, and continual improvement for regulated medical instruments. The role emphasizes lean practices, built‑in quality, and NPI ownership across cross‑functional teams in a high‑mix environment.

The candidate will drive CAPA, document control, and regulatory compliance (ISO 13485, FDA 21 CFR 820) while mentoring junior staff and collaborating with R&D, QA, and production to ensure