Senior Mechanical Engineer – Medical Devices & NPD

Abbott; Alameda (CA); On-site; USD 131,000 - 261,000; Full time

Job summary

Abbott in Alameda, CA is seeking a seasoned mechanical design engineer to lead new medical device development and design transfer. You will address complex technical challenges, mentor peers, and drive cross-functional programs with Operations, Quality, and Regulatory teams.

The role emphasizes design for manufacturability, regulatory compliance (FDA ISO 13485), and robust design documentation, with significant impact on product timelines and patient outcomes.

Qualifications

• Bachelor’s degree in mechanical engineering or equivalent; Master’s preferred.
• Minimum 10 years related engineering experience.
• Strong technical knowledge of mechanical engineering and medical device regulations.
• Familiar with ISO 13485 and FDA guidelines.

Responsibilities

• Specify, design, verify and validate new mechanical designs per medical standards.
• Lead technical investigations of manufacturing issues.
• Develop project plans, schedules, and design control documentation.
• Manage resources, budgets, and cross-functional teams.
• Mentor mechanical engineering team and review ECs.
• Ensure compliance with quality systems and regulatory requirements.

Skills

Mechanical engineering

Communication skills

Verbal/written communication

Education

Bachelor’s degree in mechanical engineering

Master’s degree (preferred)

Job description

Abbott in Alameda, CA is seeking a seasoned mechanical design engineer to lead new medical device development and design transfer. You will address complex technical challenges, mentor peers, and drive cross-functional programs with Operations, Quality, and Regulatory teams.

The role emphasizes design for manufacturability, regulatory compliance (FDA ISO 13485), and robust design documentation, with significant impact on product timelines and patient outcomes.