Senior Product Development Engineer

Abbott Laboratories; San Jose (CA); On-site; USD 90,000 - 180,000; Full time

Benefits offered by this job

Medical coverage

Tuition reimbursement

Retirement plan

Career development

Job summary

Abbott is seeking a Senior Product Development Engineer to join the R&D team in Santa Clara, CA. You will lead design verification activities for innovative medical device systems and drive engineering solutions through rigorous testing, root-cause analysis, and design changes.

This role requires hands-on development, strong communication, and collaboration across functions in a fast-paced environment. The position emphasizes technical leadership, Mentorship, and adherence to FDA/ISO quality

Qualifications

• Bachelor's degree in Mechanical Engineering, Biomedical Engineering, or related field.
• 5+ years of engineering experience in medical device product development or a regulated environment.
• Experience leading design verification and product development activities.
• Experience conducting failure investigations and applying root-cause analysis.
• Proficiency with SolidWorks and CAD drawings; able to create engineering documentation including drawings and BOMs.
• Working knowledge of GD&T and tolerance stack analysis.
• Strong technical writing, communication, and problem-solving skills.
• Ability to define product specifications and lead complex projects.
• Experience with catheter-based or minimally invasive medical devices.

Responsibilities

• Lead design verification activities for medical device systems and subsystems, including protocols and fixtures.
• Perform test execution, data analysis, and report writing.
• Lead investigations and implement design improvements and corrective actions.
• Design mechanical components and test fixtures using SolidWorks.
• Support product development through prototyping, testing, and refinement.
• Apply engineering analysis and risk management to drive decisions.
• Assist supplier development and manufacturing readiness activities.
• Communicate findings through reports and design reviews, mentoring junior engineers.

Skills

SolidWorks

GD&T

Technical writing

Root cause analysis

Project leadership

Cross-functional collaboration

Analytical skills

Education

Bachelor's degree in Mechanical Engineering or related field

Tools

Documentation tools (MS Office)

Job description

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 115,000 colleagues serve people in more than 160 countries.

JOB DESCRIPTION

Working at Abbott: At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life.

What you’ll get

• Career development with an international company where you can grow the career you dream of.
• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• An excellent retirement savings plan with a high employer contribution.
• Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.
• A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune.
• A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists.

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 SantaClara, 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.
• Experience with catheter‑based, minimally invasive, implantable, or disposable medical devices.

Preferred Qualifications

• 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.

Job details

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)

Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.

EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf

EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf

Abbott is about the power of health. For more than 135 years, Abbott has been helping people reach their potential - because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 160 countries, we create new solutions - across the spectrum of health, around the world, for all stages of life. Whether it’s next‑generation diagnostics, life‑changing devices, science‑based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health. The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well‑being of millions of people. They push the boundaries to help manage and treat some of life’s greatest health challenges.

We invite you to explore opportunities at Abbott, to see if your talents and career aspirations may fit with our openings. An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.

Follow Us: Facebook LinkedIn YouTube Twitter