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 114,000 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 (https://www.abbott.com/corpnewsroom/strategy-and-strength/tackling-student-debt-for-our-employees.html) student debt program, and FreeU (https://www.abbott.com/corpnewsroom/strategy-and-strength/college-degree-for-free-its-possible-with-freeu.html) 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** This position works out of our Menlo Park, CA location in the SH division. Structural Heart Business Mission: Why We Exist. Our business purpose is to restore health and improve quality of life by designing and providing device and management solutions for treating structural heart disease. We are seeking a **Staff Advance Engineer** with extensive experience in mechanical design, statistical analysis, and finite element analysis (FEA) to lead critical design efforts within our NPI team. This staff-level role requires strong technical leadership, deep domain expertise, and the ability to drive complex engineering projects from concept through commercialization in a regulated environment. The ideal candidate is an expert in **SolidWorks** , highly proficient in statistical tools such as **JMP or Minitab** , and has a proven track record of solving challenging engineering problems, mentoring junior engineers, and influencing cross-functional technical decisions. Experience working under FDA and ISO design controls is essential. **What You’ll Work On** **Technical Leadership** + Serve as a subject matter expert (SME) for mechanical design, FEA modeling, and statistical analysis. + Provide technical leadership and mentorship to junior and mid-level mechanical engineers. + Lead design reviews, risk assessments, and cross-functional technical discussions. **Mechanical Design** + Architect and develop complex mechanical systems using **SolidWorks** with expert-level proficiency. + Lead the creation of detailed designs, assemblies, and drawings, including high-complexity components. + Perform advanced tolerance stack-ups and GD&T to ensure robust system performance. + Guide design for manufacturability (DFM) and design for assembly (DFA) across multiple manufacturing processes. **Finite Element Analysis (FEA)** + Lead the setup, execution, and interpretation of advanced FEA, including nonlinear, dynamic, fatigue, and thermal analyses. + Validate simulation models with experimental test data and drive design refinements based on results. + Establish FEA best practices and coach the team on modeling techniques and quality standards. **Statistical & Data Analysis** + Utilize **JMP or Minitab** to perform advanced statistical modeling, DOE, tolerance analysis, and reliability assessments. + Lead data-driven problem-solving efforts using root cause methodologies and statistical rigor. + Guide teams on statistical methods for verification and validation. **Medical Device Development** + Lead and contribute to design documentation, test protocols, V&V reports, risk management files, and design control deliverables. + Ensure compliance with medical device regulations including **FDA 21 CFR 820** , **ISO 13485** , and **ISO 14971** . + Collaborate closely with R&D, Quality, Manufacturing, and Clinical teams to guide design decisions. ​ **Required Qualifications** + Bachelors Degree (± 16 years) in the engineering field or an equivalent combination of education and work experience. + Masters Degree (± 18 years) preferred. + Minimum 9 years related work experience. **Required Technical Skill Sets** **Mechanical Design** + Expert proficiency in **SolidWorks** (advanced surfacing, complex assemblies, detailed drawings). + Mastery of GD&T, tolerance stack-up analysis, and mechanical system integration. + Deep understanding of materials science and medical device-relevant manufacturing processes. **FEA Expertise** + Hands-on mastery of structural FEA tools (SolidWorks Simulation, ANSYS, Abaqus, or equivalent). + Ability to model nonlinear materials, contact mechanics, large deformation, fatigue, and dynamic loading. + Strong ability to correlate simulations with physical test results. **Advanced Statistics** + Proficient in using **JMP or Minitab** for: + Complex DOE (full factorial, RSM, mixture designs) + Advanced regression modeling + Capability studies and SPC + Reliability/life data analysis (Weibull, ALT) + Variance component modeling, MSA, and multivariate methods **Medical Device Expertise** + In-depth understanding of design control processes. + Demonstrated experience working within FDA-regulated and ISO-compliant environments. + Experience leading risk management (FMEA, hazard analysis) activities. **Soft Skills & Leadership Competencies** + Strong leadership presence with the ability to influence without authority. + Proven track record of mentoring and developing engineering talent. + Exceptional analytical, communication, and technical writing abilities. + Comfortable navigating ambiguity and driving clarity in complex design challenges. + Highly collaborative with strong cross-functional communication skills. Apply Now (https://www.jobs.abbott/us/en) **Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives:** www.abbottbenefits.com (http://www.abbottbenefits.com/pages/candidate.aspx) 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. Connect with us at www.abbott.com , on Facebook at www.facebook.com/Abbott , and on Twitter @AbbottNews. The base pay for this position is $114,000.00 – $228,000.00. In specific locations, the pay range may vary from the range posted. An Equal Opportunity Employer Abbot welcomes and encourages diversity in our workforce. We provide reasonable accommodation to qualified individuals with disabilities. To request accommodation, please call 224-667-4913 or email corpjat@abbott.com