Senior Mechanical Engineer, Medical Devices & Systems

Stark Pharma Solutions Inc; Oakland (CA); On-site; USD 170,000 - 230,000; Full time

Job summary

Stark Pharma Solutions Inc. in Oakland, CA is seeking a Senior Mechanical Engineer to provide technical leadership for Class II/III medical devices. You will support design, verification, validation, reliability, investigations, and manufacturing activities.

Responsibilities include leading sustaining engineering, CAPA investigations, and risk management while coordinating with R&D, Quality, Regulatory, and Manufacturing teams. Travel up to 10% may be required.

Qualifications

• Bachelor's degree in Mechanical or Biomedical Engineering required.
• 15+ years in Class II/III medical devices.
• Experience with FDA Design Controls and 21 CFR Part 820.
• Strong GD&T, tolerance analysis, and CAD skills.
• Knowledge of ISO 13485, EU MDR compliance.
• Experience with VADs, extracorporeal blood pumps, oxygenators is highly relevant.
• Willingness to travel up to 10%.

Responsibilities

• Lead sustaining engineering activities for medical devices.
• Support design, verification, validation, and product improvements.
• Work on VADs, blood pumps, oxygenators, and electromechanical systems.
• Lead technical investigations, complaints, CAPAs, and nonconformances.
• Perform root cause analysis and failure investigations.
• Develop test methods, protocols, fixtures, and equipment.
• Evaluate product performance and reliability.
• Support risk management and FMEA activities.
• Review engineering drawings, specifications, tolerances, and GD&T.
• Perform tolerance analysis and engineering stack-ups.
• Support design reviews and provide technical guidance.
• Mentor engineers and provide technical coaching.
• Evaluate machining, injection molding, extrusion, welding, bonding, and assembly processes.
• Support supplier selection, qualification, and technical evaluations.
• Analyze manufacturing, complaint, post-market, and reliability data.
• Support reliability testing, accelerated life testing, fatigue analysis, DOE, SPC, and Six Sigma activities.
• Work with R&D, Quality, Regulatory, Manufacturing, Operations, Suppliers, and Clinical teams.
• Support regulatory submissions, audits, inspections, and regulatory inquiries.
• Ensure compliance with FDA, 21 CFR Part 820, ISO 13485, ISO 14971, EU MDR, and QMS requirements.
• Support external manufacturing partners and global suppliers.
• Contribute to continuous improvement, product quality, and operational excellence.

Skills

Leadership

GD&T

FMEA

DOE

Six Sigma

CAD

Regulatory knowledge (FDA)

Education

Bachelor's degree in Mechanical/Biomedical Engineering

Master's degree beneficial

Job description

Stark Pharma Solutions Inc. in Oakland, CA is seeking a Senior Mechanical Engineer to provide technical leadership for Class II/III medical devices. You will support design, verification, validation, reliability, investigations, and manufacturing activities.

Responsibilities include leading sustaining engineering, CAPA investigations, and risk management while coordinating with R&D, Quality, Regulatory, and Manufacturing teams. Travel up to 10% may be required.