R&D Engineer

Position Description:
R&D Engineer for Medtronic, Inc located in Santa Ana, CA. Responsible for the development and improvement of new transcatheter valve replacement products. Develop design concepts/prototypes/test methodology to conduct material, component, and implant level testing to meet development and regulatory requirements. Document design within applicable Design Control, Quality and Regulatory requirements. Conduct design verification and validation testing per approved protocols and document in accordance with applicable development regulatory requirements. Leverage clinical and technical Applications for cardiovascular products, including Transcatheter and Surgical heart valves, human anatomy, and all phases of the Product Development Process (PDP). Responsible for Medical Device Design specifically in Bioprosthetic heart valves, including prototyping and system interactions with soft tissue and shape memory alloys. Translate patient/physician needs into design input requirements in compliance with Design Controls Standards including ISO 5840. Leverage Mechanical Testing and Prototyping including mechanical testing including tension/compression and bending, and fixture prototyping for Bioprosthetic heart valves, including pulsatile hydrodynamic and biaxial testing. Responsible for fluid flow measurements using MATLAB and Python, as well as Finite Element Modeling and Analysis (FEM/FEA) software including ANSYS, ABAQUS, and HyperMesh. Run Durability and Fatigue Analysis of soft tissue, including S-N curve generation through simulations using 3D image processing software including Materialise Mimics, and automated measurement software. Responsible for Engineering Analysis and Biomechanics with applications in structural heart implant design, tolerance stack-up, mechanical design, and material characterization. Specialization in structural analysis of shape memory alloys and soft materials, with proficiency in statistical techniques including hypothesis testing, predictive analysis, and machine learning for soft tissue characterization. Leverage Good Laboratory Practices (GLP) and Good Documentation Practices (GDP). #LI-DNI.

*Position works a hybrid model and will be onsite in Santa Ana, CA four (4) days per week. Relocation assistance not provided.

NOTICE: Pursuant to 20 C.F.R. § 656.10, you are hereby notified that an Application for Permanent Employment Certification will be filed for the job opportunity below. Any individual may provide documentary evidence bearing on this application, with information on available workers and information on wages and working conditions, to the Certifying Officer at the U.S. Department of Labor as follows:

Certifying Officer
U.S. Department of Labor
Employment and Training Administration
Office of Foreign Labor Certification
200 Constitution Avenue NW, Room N-5311
Washington, DC 20210

Basic Qualifications:
Master’s degree in Mechanical, Industrial or Biomedical Engineering or related engineering field and six (6) months of experience as an R&D engineer or related occupation. Must possess experience gained through internships, research, coursework and/or work experience, with each of the following: Clinical and technical applications of cardiovascular products, including Transcatheter and Surgical heart valves, human anatomy, and PDP; Designing implantable heart valves using SMA in compliance with ISO 5840; Mechanical Testing of heart valves, including tension, compression, bending, pulsatile hydrodynamic, biaxial, and Durability and Fatigue; Test fixture and device prototyping; MATLAB, Python, ANSYS, ABAQUS, HyperMesh, Materialise Mimics, and automated measurement software; and Engineering Analysis and Biomechanics for structural heart implant design, tolerance stack-up, hypothesis testing, predictive analysis, machine learning, mechanical design, material characterization, and S-N curve generation.

The position is located at Medtronic, Inc., 1851 E. Deere Ave, Santa Ana, CA 92705.

Salary: $97,000 to $124,800 per year

THIS POSITION QUALIFIES FOR THE MEDTRONIC EMPLOYEE REFERRAL BONUS PROGRAM AT THE LEVEL OF $1,000. Refer to the program guidelines located at InternalJobs.Medtronic.com.

The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program).

The following benefits and additional compensation are available to all regular employees: Incentive plans, 401(k) plan plus employer contribution and match, Short-term disability, Paid time off, Paid holidays, Employee Stock Purchase Plan, Employee Assistance Program, Non-qualified Retirement Plan Supplement (subject to IRS earning minimums), and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums).

Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico.

Further details are available at the link below:
https://www3.benefitsolver.com/benefits/BenefitSolverView?page_name=signon&co_num=30601&co_affid=medtronic