Sr. Mechanical Engineer

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

About The Company

Stark Pharma Solutions Inc. is a global consulting and staffing partner established in 2014, serving the Pharmaceutical, Medical Device, Biotech, and IT industries across the USA, Canada, and India. We provide specialized consulting and staffing solutions across Quality & Validation, Regulatory Affairs, R&D, Manufacturing, Supply Chain, Project Management, and IT, with a focus on delivering tailored solutions that drive growth, operational excellence, and long-term client success.

About The Company

Stark Pharma Solutions Inc. is a global consulting and staffing partner established in 2014, serving the Pharmaceutical, Medical Device, Biotech, and IT industries across the USA, Canada, and India. We provide specialized consulting and staffing solutions across Quality & Validation, Regulatory Affairs, R&D, Manufacturing, Supply Chain, Project Management, and IT, with a focus on delivering tailored solutions that drive growth, operational excellence, and long-term client success.

Job Title: Sr. Mechanical Engineer

Location: Oakland, CA

Duration: Long Term

Job Overview

We are looking for a Senior Mechanical Engineer to provide technical leadership for complex Class II and Class III medical devices. The role will support product design, sustaining engineering, verification, reliability, investigations, and manufacturing activities.

Key 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.

Basic Qualifications

• Bachelor s degree in Mechanical Engineering, Biomedical Engineering, Manufacturing Engineering, or a related field.
• 15+ years of engineering experience in Class II and/or Class III medical devices.
• Experience in product development, sustaining engineering, verification and validation, manufacturing support, and risk management.
• Strong experience with mechanical design, GD&T, tolerance analysis, materials, and manufacturing processes.
• Experience leading technical investigations and root cause analysis.
• Experience with FDA Design Controls and 21 CFR Part 820.
• Experience with FMEA and medical device risk management.
• Experience with CAD systems and engineering drawings.
• Experience with medical device manufacturing processes.
• Experience with VADs, extracorporeal blood pumps, oxygenators, cardiovascular implants, or other Class III medical devices is highly relevant.
• Experience with complaint investigations, CAPA, post-market surveillance, and reliability activities.
• Knowledge of ISO 13485, ISO 14971, EU MDR, and applicable medical device regulations.
• Experience with DOE, SPC, Six Sigma, reliability engineering, or statistical analysis.
• Experience working with suppliers and external manufacturing partners.
• Strong communication, presentation, problem-solving, and leadership skills.
• Master s degree in Mechanical Engineering, Biomedical Engineering, or a related field is beneficial.
• Ability to travel approximately 10%, including domestic and occasional international travel.

Stark Pharma is an Equal Opportunity Employer and welcomes qualified candidates from diverse backgrounds.