Sr. R&D Mechanical Engineer

Intellectt Inc; Phoenix (AZ); On-site; USD 120,000 - 180,000; Full time

Job summary

Intellectt Inc in Phoenix, AZ is seeking a Senior R&D Mechanical Engineer to provide technical leadership for sustaining, verification, investigation, and reliability improvement of complex Class II and Class III medical devices throughout the product lifecycle.

You will guide cross-functional teams, perform root cause analysis, develop testing strategies, and mentor engineers while ensuring compliance with FDA Design Controls and ISO 13485.

Qualifications

• Bachelor's degree in Mechanical, Biomedical, Manufacturing Engineering, or related field.
• 10+ years of engineering experience with progressively increasing responsibility.
• Strong experience supporting Class II and/or Class III medical devices.
• Experience in product development, sustaining engineering, V&V, manufacturing support, and risk management.
• Demonstrated technical leadership of complex cross-functional engineering programs.
• Knowledge of FDA Design Controls, 21 CFR Part 820, and medical device lifecycle processes.

Responsibilities

• Lead sustaining engineering activities for Class II/III medical devices.
• Lead technical investigations related to product complaints, CAPAs, nonconformances, and field issues.
• Perform root cause analysis and develop corrective/preventive actions.
• Support mechanical and electromechanical product development, testing, and sustaining activities.
• Drive product, process, and reliability improvements across the product lifecycle.
• Develop test strategies, methods, protocols, fixtures, and equipment for verification and reliability testing.
• Collaborate with Quality, Regulatory, Manufacturing, Operations, Clinical, and Supplier teams.

Skills

GD&T

Tolerance analysis

Materials

Manufacturing processes

Assembly methods

Technical communication

Education

Bachelor's degree in Mechanical Engineering or related field

Tools

CAD

DOE

SPC

Six Sigma

Project management

Job description

• We are seeking a Senior R&D Mechanical Engineer to provide technical leadership for sustaining, verification, investigation, and reliability improvement of complex Class II and Class III medical devices.
• The engineer will serve as a technical subject matter expert, leading complex investigations, product improvements, verification activities, reliability initiatives, and system-level problem-solving throughout the product lifecycle.
• Experience with Ventricular Assist Devices (VADs), extracorporeal blood pumps, oxygenators, or other complex cardiovascular/implantable medical devices is highly preferred.

Key Responsibilities

• Lead sustaining engineering activities for Class II/III medical devices.
• Lead technical investigations related to product complaints, CAPAs, nonconformances, and field issues.
• Perform root cause analysis and develop corrective/preventive actions.
• Support mechanical and electromechanical product development, testing, and sustaining activities.
• Drive product, process, and reliability improvements across the product lifecycle.
• Develop test strategies, methods, protocols, fixtures, and equipment for verification and reliability testing.
• Analyze product performance, failure data, complaint data, manufacturing data, and reliability trends.
• Identify technical risks and develop mitigation strategies.
• Create and review engineering drawings and specifications.
• Perform tolerance analysis, engineering stack-ups, GD&T reviews, and design-for-manufacturability assessments.
• Support design reviews and provide technical guidance to engineering teams.
• Mentor engineers and provide technical coaching.
• Evaluate manufacturing processes including machining, injection molding, silicone molding, extrusion, laser welding, ultrasonic welding, bonding, and mechanical assembly.
• Support supplier selection, qualification, and technical evaluations.
• Collaborate with Quality, Regulatory, Manufacturing, Operations, Clinical, and Supplier teams.
• Support regulatory submissions, audits, inspections, and regulatory inquiries.
• Ensure compliance with FDA regulations, Quality Management Systems, and applicable medical-device standards.

Required Qualifications

• Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Manufacturing Engineering, or related engineering discipline.
• 10+ years of engineering experience with progressively increasing responsibility.
• Strong experience supporting Class II and/or Class III medical devices.
• Experience in product development, sustaining engineering, V&V, manufacturing support, and risk management.
• Demonstrated technical leadership of complex cross-functional engineering programs.
• Strong knowledge of FDA Design Controls, 21 CFR Part 820, and medical device product lifecycle processes.
• Proven experience leading technical investigations and root cause analysis.

Strong expertise in:

• GD&T
• Tolerance analysis
• Materials
• Manufacturing processes
• Assembly methods
• Excellent technical communication and presentation skills.
• Ability to work effectively with engineering, management, Quality, Regulatory, suppliers, auditors, and customers.

Preferred Qualifications

• Master's degree in Mechanical, Biomedical, Manufacturing Engineering, or related field.
• Experience with VADs, extracorporeal blood pumps, oxygenators, cardiovascular implants, or other Class III/implantable medical devices.
• Experience with complaint investigations, CAPA, post-market surveillance, and reliability engineering.
• Experience with accelerated life testing, fatigue analysis, and statistical data analysis.
• Experience in medium- to high-volume medical device manufacturing.
• Experience with CAD, DOE, SPC, Six Sigma, and project management.
• Knowledge of ISO 13485, ISO 14971, EU MDR, and other medical device standards.
• Experience working with external manufacturing partners and global suppliers.
• Exposure to electrical systems, software-controlled devices, polymers, biomaterials, and biological systems.