Senior Medical Device Manufacturing Engineer

Spacelabs Healthcare; Snoqualmie (WA); On-site; USD 125,000 - 135,000; Full time

Job summary

Spacelabs Healthcare in Snoqualmie, WA is seeking a proficient manufacturing engineer specializing in electronics and PCBA replacement. You will lead process improvements, cost reduction, and ensure manufacturability with R&D collaboration.

The role requires 8+ years in manufacturing engineering, knowledge of medical device release (IQ/OQ/PQ), and strong cross-functional communication to drive quality and regulatory compliance.

Qualifications

• Bachelor’s Degree in Electronics Engineering or Manufacturing Engineering or equivalent experience.
• 8+ years of relevant manufacturing engineering experience.
• Experience in electronics design preferred.
• Related experience in medical device field.
• Knowledge of medical product release process into manufacturing (IQ, OQ, PQ, TMV, verification and validation activities).
• Excellent problem-solving and cross-functional collaboration skills.

Responsibilities

• Develop, document, improve, and own manufacturing processes. Create process plans and equipment designs and document process validations.
• Establish, simulate, design, test, and implement improvements focused on cost and quality.
• Act as SME on BOMs, drawings, specs, labels, licenses, and changes.
• Perform root cause and failure analysis for field problems related to design or manufacturing.
• Lead cross-functional initiatives impacting quality, manufacturability, cost, and supply continuity.
• Coordinate with R&D to influence product design and manufacturing strategy.
• Review and disposition nonconformities with QA & supply chain for corrective actions.
• Maintain manufacturing engineering standards and validation methodologies.
• Ensure regulatory compliance (FDA, MDD, UL, CSA etc.) and manage obsolescence issues.
• Mentor and guide Manufacturing Engineers and Technicians.

Skills

Root Cause Analysis

Cross-functional Collaboration

Problem Solving

Independent Work

Manufacturing Engineering

Electronics Design

Education

Bachelors in Electronics/Manufacturing Engineering

Tools

IQ/OQ/PQ

Verification & Validation

Job description

Spacelabs Healthcare in Snoqualmie, WA is seeking a proficient manufacturing engineer specializing in electronics and PCBA replacement. You will lead process improvements, cost reduction, and ensure manufacturability with R&D collaboration.

The role requires 8+ years in manufacturing engineering, knowledge of medical device release (IQ/OQ/PQ), and strong cross-functional communication to drive quality and regulatory compliance.