R&D FEA/Test Engineer
The Role
Support the product development of a cutting edge structural heart device through performing theoretical and finite element analysis (FEA) to predict system behaviour which will support design development and verification activities.
Reporting Lines
Reports directly to the Head of R&D.
Key Responsibilities and Duties
Utilise finite element analysis to assist in the design, optimization, testing verification and method validation of structural heart device.
Serve as implant load and stress subject matter expert for product development to supporting bringing product to clinical trials.
Perform baseline load and stress analysis of new designs, maintain analysis files, document results and obtain peer reviews.
Work in SolidWorks to review, import and optimise models.
Perform model validation with hand calculations and physical test correlation.
Prepare reports and presentations to communicate the assessments and analysis results in an easy to understand format for the understanding of others.
Provide technical input supporting submissions to regulatory bodies.
Contribute toward inventions and new designs on development projects.
Ensure interactions with colleagues/stakeholders fully reflects the company values:
One Team: working together to ensure the whole is greater than the sum of the parts
Personal Ownership: deliver on commitments
Open Communication: Honest open-minded communication
Fun: celebrate the successes
Continuous Learning: at an individual and company level
Solution Orientated: Identify problems but focus your energy on solutions
Quality Focused: patient safety comes first
Essential Requirements
Technical: Strong technical aptitude with a deep understanding of the finite element method. Fundamental understanding of engineering principles and techniques in the design and development of medical devices, ideally cardiovascular devices. Broad materials and processing knowledge.
Problem Solving: Supports a culture of data-driven problem solving and technical decisions that ensure development of high quality devices. This includes adherence to any systems / processes for robust data capture, analysis and presentation of technical information to guide the decision-making process.
Project Management: Demonstrates project management & organisational skills. Ability to complete individual tasks on time and on budget. Able to effectively plan own work when provided outline assignments. Effectively communicates budget needs for development activities.
Initiative: Demonstrated ability to take initiative to prioritize work, reach business objectives and challenge task team decisions as required.
People Skills: Demonstrates people skills to work effectively with others to achieve company goals.
Communication: Effective verbal and written technical communication skills of technical information. Demonstrated effective presentation and group communication skills.
Education and Experience
B.S. or masters degree in mechanical engineering, biomedical engineering, or related disciplines.
Three years of experience working in finite element analysis (FEA) in or PhD with hands on experience with ABAQUS.
Knowledge of engineering mechanics, mechanical design, material processing, fatigues analysis, metallurgy and strength of materials.
Experience operating in a regulated environment, preferably medical devices with knowledge of Nitinol processing and properties.
Experience working with SolidWorks and CAD software.
Working knowledge of FDA, GMP, QSR and ISO 13485 requirements.
The above role profile is not designed to cover a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities and activities may change or new ones may be assigned from time to time
To apply for this position please send your CV and cover letter to info@croivalve.com