Sr. Staff Advanced Engineer
About The Position
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 122,000 colleagues serve people in more than 160 countries. This position works out of our Temecula, CA location in the SH division. 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 Sr. Staff Advanced 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.
Requirements
- Bachelors Degree (± 16 years) in the engineering field or an equivalent combination of education and work experience.
- Minimum 9 years related work experience.
- 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.
- 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.
- 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.
- 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.
- 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.
Nice To Haves
- Masters Degree (± 18 years) preferred.
Responsibilities
- 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.
- 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.
- 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.
- 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.
- 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.
Benefits
- 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.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
