Senior Product Development Engineer

RXinsider LTD.; Santa Clara, Northern (CA, KY); Hybrid; USD 90,000 - 180,000; Full time

Job summary

Abbott in Santa Clara, CA, seeks a Senior Product Development Engineer to lead design verification and drive test methods, reports, and corrective actions for medical device systems. You will contribute to new product design, prototyping, and design transfer while mentoring junior engineers.

The role requires strong mechanical engineering fundamentals, hands-on development experience, and independent delivery in a fast-paced environment. Onsite work five days a week in Santa Clara.

Qualifications

• Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, or related field.
• 5+ years in medical device product development or regulated environment.
• Experience leading design verification and product development activities.
• Experience conducting failure investigations and applying root‑cause analysis.
• Proficiency with SolidWorks and creating CAD models, drawings, and documentation.
• Working knowledge of GD&T and tolerance stack analysis.
• Strong technical writing, communication, and problem‑solving skills.

Responsibilities

• Lead design verification activities for medical device systems and subsystems, including test protocols and fixtures.
• Lead failure investigations and implement design improvements and corrective actions.
• Design mechanical components, assemblies, fixtures, and test hardware; produce drawings and BOMs.
• Support product development from concept through prototype and testing.
• Apply risk management, GD&T, and sound engineering judgment to drive decisions.
• Support manufacturing readiness, supplier development, and design transfer.

Skills

Design verification

Root cause analysis

SolidWorks

CAD drawings

GD&T

Technical writing

Cross-functional teamwork

Medical device

Education

Mechanical Engineering

Biomedical Engineering

Tools

SolidWorks

CAD software

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.

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. You’ll also have access to :

• 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 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.
• 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.

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.

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.

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