Mechanical Engineer VI

Abbott • Alameda, CA

1d • Onsite

About The Position

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 Join us at Abbott Diabetes Care (ADC) in our mission to help individuals with diabetes lead active, fulfilling lives. We’re focused on helping people manage their health more effectively and comfortably, with life-changing products that provide accurate data to drive better-informed decision. The Senior Mechanical Engineer performs product failure ‑ analysis activities across clinical studies, early access programs, and manufacturing AQL invitro test, serving as a key technical consultant to R&D developers, Quality, and Manufacturing teams. This role oversees operation and maintenance of the clinical investigation laboratory. This is an onsite opportunity based out of Alameda, CA.

Requirements

• Bachelor of Science (Mechanical Engineering preferred) or equivalent relevant experience
• Minimum 10 years of related experience in engineering and at least 2 years of engineering management experience.
• Demonstrated ability to draw conclusions based on evidence.
• Experience with medical device systems development per FDA and EU design control regulations.
• Demonstrated success in technical proficiency, creativity, and independent thought.
• Ability to conduct thorough data analytics & implement data-driven solutions.
• Strong analytical & problem-solving skills.
• Ability to provide guidance to junior team members.

Nice To Haves

• Experience preparing auditable responses for FDA and other regulatory bodies.
• Good understanding of processes used in the design, documentation, and verification of medical devices or IVD.
• Experience working with biohazard material or in chemical laboratories.

Responsibilities

• Conduct failure investigations supporting clinical studies, design verification, and product performance assessments.
• Review, interpret, and synthesize complex physical, written, and digital data to draw well-supported technical conclusions.
• Execute laboratory testing and evaluate results using sound engineering judgment, and first principles.
• Document investigation activities and findings in formal reports, including clinical study and design verification documentation.
• Maintain complete and accurate records of investigations, test results, and analyzed products.
• Manage the intake, logging, organization, and disposition of products requiring investigation, including biohazard handling and controlled material separation.
• Maintain a compliant laboratory environment, including biohazard lab operations and material disposal practices.
• Coordinate investigation activities across cross ‑ functional teams and internal stakeholders.
• Communicate effectively with electrical, mechanical, embedded software, quality, clinical, and management teams to drive timely resolution of issues.
• Provide technical leadership, mentoring, and subject ‑ matter expertise for both investigations and new product development efforts.
• Participate in cross ‑ functional development teams, applying strong deductive reasoning, negotiation, and influencing skills to guide teams toward solutions.
• Contribute to the development and improvement of departmental and site processes, procedures, and investigation methodologies.
• Collaborate with developers to define investigation approaches for new products and to address identified failure modes.
• Supervise the development of investigation fixtures, hardware, and software tools as needed.
• Support additional R&D projects and initiatives as required.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees