JOB DESCRIPTION:The Opportunity This position works out of our Temecula, 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
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.
What You'll Work OnTechnical 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 SetsMechanical 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 NowLearn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com
Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life.
The base pay for this position is $113,300.00 - $226,700.00
In specific locations, the pay range may vary from the range posted.
JOB FAMILY:Engineering
DIVISION:SH Structural Heart
LOCATION:United States > Temecula : Building E - TE
ADDITIONAL LOCATIONS:United States > Menlo Park : 3885 Bohannon Drive
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)
