Senior Mechanical Engineer

* Passionate about Engineering Excellence? Vaxxas wants you! Senior Mechanical Engineer role available...Apply Now! *

Overview of position

The Senior Mechanical Engineer position is to provide design support to the Medical Device Development team to introduce Vaccine delivery devices with reliable functionality and ready for design verification and validation.

Essential duties & responsibilities

• Conduct medical device product development and design.
• Supervise or perform investigations/tests, evaluate results, and analyse data.
• Ensure verification and validation activities, needed to guarantee that product designs comply with customer and internal specifications, are carried out in a timely and technically competent manner.
• Provide leadership and guidance in the ‘Design & Development’ and ‘Verification and Validation’ of products and technically mentor and coach junior team members.
• Lead risk analysis activities such as Design Failure Mode and Effect Analysis (DFMEA).
• Identify and document intellectual property arising from the project and facilitate its protection through established procedures.
• Ensure that all documentation required to support a product’s introduction to clinical studies and manufacturing are created.

Required capabilities

• Bachelor’s degree in engineering (Mechatronics / Electrical / Mechanical / Medical or similar) with 5+ years industry work experience.
• Knowledge of ISO standards and regulatory requirements for medical devices.
• Experience in mechanical design of medical devices.
• Knowledge of six sigma methodologies.
• Understand of injection moulding and sheet metal stamping techniques.

Selection criteria

• Demonstrated 5+ years mechanical design experience for medical devices.
• Proven record of designing compliant to ISO13485 medical device design control.
• Proven use of a Product Lifecycle Management (PLM) system such as Windchill.
• Experience applying Geometric Dimensioning and Tolerancing (GD&T) to designs.

About Vaxxas

Vaxxas is a privately held, clinical stage biotechnology company focused on enhancing the performance of existing and next-generation vaccines with its proprietary high-density microarray patch (HD-MAP). Vaxxas is targeting initial applications in infectious disease and oncology.

The company’s innovative, needle-free technology can eliminate or significantly reduce the need for vaccine refrigeration during storage and transportation, easing the resource and logistics burden of maintaining the vaccine cold chain.

In addition to a Phase I clinical study of a COVID-19 vaccine candidate, Vaxxas is performing demonstration work in preparation for clinical evaluation under contract with the United States Biomedical Advanced Research and Development Authority (BARDA) on pandemic vaccination solutions, among multiple other clinical and pre-clinical programs.

The company has forged collaborations with leading global organisations in vaccine commercialisation, including Merck/MSD, CEPI, the World Health Organization (WHO), and the Bill and Melinda Gates Foundation.

Learn more at www.vaxxas.com

If you are ready to harness your expertise by making a mark at Vaxxas as a Senior Mechanical Engineer, we want to hear from you!

To be considered, please submit your Resume, together with a cover letter (outlining your core capabilities for the role, demonstrated experience of how you have delivered outcomes and why this role is of interest) by selecting the 'apply for this job' function. You will be contacted in due course if your application is successful.