The Opportunity
As a Senior Product Development Engineer, you will be part of the Abbott R&D team supporting the development, verification, and continuous improvement of innovative medical device systems. The primary focus of this role will be leading design verification activities, developing robust test methods, authoring protocols and reports, investigating product performance issues, and driving engineering solutions through design changes and corrective actions.
As product development programs advance, this individual will also contribute to new product design, prototype development, subsystem ownership, and design transfer activities. The ideal candidate combines strong design verification expertise with solid mechanical engineering fundamentals and hands-on product development experience.
This is a senior individual contributor role requiring technical leadership, sound engineering judgment, strong written communication skills, 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, CA, requiring onsite presence five days per week.
What You’ll Work On
- Lead design verification activities for medical device systems and subsystems, including development of protocols, test methods, and fixtures; test execution, statistical data analysis, and report authorship.
- Lead failure investigations, root cause analyses, and implementation of design improvements and corrective actions.
- Design mechanical components, assemblies, fixtures, prototypes, and test hardware using SolidWorks, and develop associated engineering documentation including drawings, specifications, and BOMs.
- Support product development through concept evaluation, prototyping, testing and design refinement.
- Apply engineering analysis, risk management principles, GD&T, tolerance stack-ups, and sound engineering judgment to drive technical decisions.
- Support supplier development, component qualification, manufacturing readiness, and design transfer activities.
- Communicate technical findings through reports, presentations, and design reviews, while providing 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.
Required Qualifications
- Bachelor's degree in Mechanical Engineering, Biomedical Engineering, or a related engineering discipline.
- 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 and experience 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 while collaborating effectively within cross-functional teams.
Preferred Qualifications
- Experience with catheter-based, minimally invasive, implantable, or disposable medical devices.
- 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.
Apply Now
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The base pay for this position is
$90,000.00 – $180,000.00
In specific locations, the pay range may vary from the range posted.
JOB FAMILY:Product Development
DIVISION:SH Structural Heart
LOCATION:United States > Santa Clara : Building A - SC
ADDITIONAL LOCATIONS:
WORK SHIFT:Standard
TRAVEL:Yes, 10 % of the Time
MEDICAL SURVEILLANCE:No
SIGNIFICANT WORK ACTIVITIES:Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day)
