On-Site Senior Mechanical Engineer, Medical Devices & NPD

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

Job summary

Abbott Laboratories in Alameda, CA seeks a recognized expert in mechanical design engineering to lead new product development and design transfer, resolving complex technical issues and guiding cross‑functional teams. You will specify and validate designs, manage projects, and mentor the engineering team while ensuring compliance with FDA medical device standards and quality systems.

This on-site role requires a Bachelor’s degree in mechanical engineering, at least 10 years of experience, and

Qualifications

• Bachelor’s degree in mechanical engineering; Master’s degree preferred.
• Minimum 10 years related experience in engineering.
• Strong technical experience in mechanical engineering with excellent written and verbal communication skills.
• Extensive knowledge of regulations for medical device development (ISO15197, ISO134851, ISO13485, FDA) desired.
• Extensive understanding of processes and materials used in the development and manufacturing of medical devices is ideal.

Responsibilities

• Specify, design, verify and validate new mechanical designs, in accordance with applicable medical regulatory standards.
• Support high‑level technical investigation of manufacturing line issues.
• Develop technical project plans and schedules covering all engineering activities and SOP requirements.
• Lead the development of product specifications, FMEAs, DOEs, verification and validation protocols and plans.
• Manage resources, create project schedules and set budgets.
• Communicate effectively and participate in cross functional development teams.
• Participate in technical design reviews of mechanical design, hardware, PCBA interface, mechanical assemblies, production processes, product design and requirements documents.
• Write, submittal, and approval of Engineering Changes, as required.
• May review and approve ECs.
• Act as independent reviewer on programs in which not directly involved.
• Ensure the quality system effectiveness is maintained.
• Ensure product designs, components and materials meet all applicable standards.
• Comply with Corporate and Divisional Policies.
• Develop and execute of new medical devices, processes, equipment, materials, verification and validation.
• Implement approved Design Control procedures for product development per FDA guidelines.
• Provide mentoring, technical guidance for mechanical engineering team.

Skills

Mechanical design

New product development

Design transfer

Project management

Cross-functional collaboration

Regulatory understanding

Education

Bachelor’s degree in mechanical engineering

Master’s degree preferred

Job description

Abbott Laboratories in Alameda, CA seeks a recognized expert in mechanical design engineering to lead new product development and design transfer, resolving complex technical issues and guiding cross‑functional teams. You will specify and validate designs, manage projects, and mentor the engineering team while ensuring compliance with FDA medical device standards and quality systems.

This on-site role requires a Bachelor’s degree in mechanical engineering, at least 10 years of experience, and