Senior Product Development Engineer

Abbott • Santa Clara, CA

3d • $90,000 - $180,000 • Onsite

About The Position

As a Senior Product Development Engineer on Abbott’s R&D team, you will support the development, verification, and continuous improvement of medical device systems. The primary focus is leading design verification activities, developing test methods, authoring protocols and reports, investigating product performance issues, and driving engineering solutions through design changes and corrective actions. You will also contribute to new product design, prototype development, subsystem ownership, and design transfer as product development programs advance. This senior individual contributor role calls for technical leadership, sound engineering judgment, strong written communication, and the ability to independently drive complex engineering deliverables in a fast-paced product development environment.

This is a full-time onsite position based in Santa Clara, California, with onsite presence required five days per week. The role includes travel approximately 10% of the time. Abbott states that the base pay is $90,000–$180,000, with pay potentially varying in specific locations.

Requirements

• Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, or a related engineering discipline.
• At least 5 years of engineering experience in medical device product development or a regulated product development environment.
• Demonstrated experience leading significant design verification and product development activities.
• Experience conducting failure investigations and applying structured root cause analysis techniques.
• Proficiency with SolidWorks, including creating CAD models, assemblies, engineering drawings, and product documentation.
• Working knowledge of GD&T and tolerance stack analysis.
• Strong technical writing, communication, analytical, and problem-solving skills.
• Experience defining product specifications, engineering requirements, and design inputs.
• Ability to independently lead complex technical projects and collaborate effectively within cross-functional teams.
• Experience with catheter-based, minimally invasive, implantable, or disposable medical devices.

Nice To Haves

• Experience developing products through all phases of the product lifecycle, from concept through commercialization.
• Experience supporting manufacturing, design transfer, supplier qualification, and component validation activities.
• Experience with metals, plastics, elastomers, adhesives, and associated manufacturing processes, including molding, machining, and extrusions.
• Experience with statistical analysis and test data evaluation.
• Familiarity with FDA Quality System Regulations (21 CFR Part 820), ISO 13485, and applicable medical device design controls.
• Experience mentoring engineers and providing technical leadership.

Responsibilities

• Lead design verification activities for medical device systems and subsystems, including developing protocols, test methods, and fixtures; executing tests; analyzing statistical data; and authoring reports.
• Lead failure investigations and root cause analyses, and implement design improvements and corrective actions.
• Design mechanical components, assemblies, fixtures, prototypes, and test hardware using SolidWorks; develop related drawings, specifications, and bills of materials.
• Support product development through concept evaluation, prototyping, testing, and design refinement.
• Apply engineering analysis, risk management principles, GD&T, tolerance stack-ups, and engineering judgment to technical decisions.
• Support supplier development, component qualification, manufacturing readiness, and design transfer activities.
• Communicate technical findings through reports, presentations, and design reviews; provide technical leadership, mentorship, and guidance to junior engineers.
• Maintain compliance with Abbott procedures and documentation requirements, FDA regulations, ISO standards, and applicable quality system requirements.

Benefits

• Career development opportunities with an international company.
• Employees may qualify for free medical coverage in the Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• Retirement savings plan with a high employer contribution.
• Tuition reimbursement.
• Freedom 2 Save student debt program.
• FreeU education benefit, described as an affordable and convenient path to earning a bachelor’s degree.
• Health and wellness benefits.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior