JOB DESCRIPTION:The Opportunity As a Product Development Engineer, you will be part of the Abbott R&D team supporting the development and verification of innovative medical device systems. This role will play a key part in planning, developing, executing, and documenting design verification activities throughout the product development lifecycle.
The ideal candidate will have strong experience in design verification testing, mechanical engineering, fixture and test method development, failure investigation, and technical documentation. This individual will work closely with cross-functional teams to evaluate design performance, develop innovative test solutions, investigate failures, and ensure devices meet product requirements and regulatory expectations.
This is an individual contributor role requiring technical depth, hands-on engineering capability, strong written communication skills, and the ability to independently drive 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- Plan, develop, and execute design verification activities for medical device systems and subsystems.
- Design, develop, and qualify test methods, test fixtures, and test equipment to evaluate device performance against product requirements.
- Author, review, and execute design verification protocols, test methods, engineering studies, and test reports.
- Perform hands-on testing, data collection, statistical analysis, and interpretation of test results.
- Develop creative and practical approaches to evaluate challenging product requirements and design characteristics.
- Investigate design verification failures and product performance issues using structured root cause analysis methodologies.
- Lead failure analysis activities, including mechanical evaluations, inspection, measurement, troubleshooting, and corrective action recommendations.
- Design mechanical components, fixtures, prototypes, and test hardware using SolidWorks.
- Support hands-on development activities including prototype builds, assembly, modification, and evaluation of engineering designs.
- Collaborate with Design, Quality, Regulatory, Clinical, Manufacturing, and Supplier teams to ensure verification activities are aligned with product requirements and project objectives.
- Support risk management activities through verification of risk control measures and investigation of potential product hazards.
- Communicate effectively through written documentation, verbal discussions, and technical presentations.
- Maintain compliance with Abbott procedures and documentation requirements, FDA regulations, ISO standards, and other regulatory requirements.
Required Qualifications- Bachelor's degree in Mechanical Engineering, Biomedical Engineering, or a related engineering discipline.
- 3+ years of engineering experience in medical device product development or a regulated product development environment.
- Experience planning, executing, and documenting design verification activities.
- Experience authoring and executing test protocols, test methods, and test reports.
- Experience designing and developing test fixtures and test equipment.
- Experience conducting failure investigations and root cause analysis.
- Proficiency with SolidWorks CAD for component design, fixture development, and engineering drawings.
- Strong technical writing skills with demonstrated experience authoring engineering documentation.
- Strong analytical and problem-solving skills.
- Strong verbal and written communication skills.
- Ability to work independently while effectively collaborating within cross-functional teams.
Preferred Qualifications- Experience with catheter-based or minimally invasive medical devices.
- Experience supporting manufacturing and design transfer activities.
- Experience with statistical analysis and test data evaluation.
- Experience with GD&T, tolerance analysis, and mechanical design principles.
- Familiarity with FDA Quality System Regulations (21 CFR Part 820), ISO 13485, and applicable medical device development processes.
Apply NowLearn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com
Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life.
The base pay for this position is $81,500.00 - $141,300.00
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)
