Senior Mechanical Engineer – Medical Devices & NPD Lead

Thornton Tomasetti; Alameda (CA); Hybrid; USD 131,000 - 261,000; Full time

Job summary

Abbott Laboratories in Alameda, CA seeks a Principal Mechanical Engineer to lead design and development of medical devices, manage design transfer, and resolve complex technical issues with cross-functional teams. You will specify and validate new designs, develop DFMEA/DOE, manage budgets and schedules, and mentor engineers while ensuring compliance with FDA ISO standards.

This role requires a minimum of 10 years in mechanical engineering and strong communication, with on-site work and periodic

Qualifications

• Bachelor's degree required; master's preferred.
• Minimum 10 years of related engineering experience.
• Experience with medical device regulations (FDA, ISO 13485).
• Extensive knowledge of medical device regulations (ISO15197, ISO13485, FDA).

Responsibilities

• Specify, design, verify and validate new mechanical designs per medical standards.
• Lead technical investigations and design reviews across teams.
• Develop project plans, schedules and budgets for engineering activities.
• Mentor mechanical engineering staff and ensure design control compliance.
• Coordinate with cross-functional groups (Operations, Quality, Regulatory).

Skills

Mechanical design

Regulatory knowledge

Communication

Project leadership

Education

Bachelor's degree in mechanical engineering

Master's degree preferred

Job description

Abbott Laboratories in Alameda, CA seeks a Principal Mechanical Engineer to lead design and development of medical devices, manage design transfer, and resolve complex technical issues with cross-functional teams. You will specify and validate new designs, develop DFMEA/DOE, manage budgets and schedules, and mentor engineers while ensuring compliance with FDA ISO standards.

This role requires a minimum of 10 years in mechanical engineering and strong communication, with on-site work and periodic