Vestech provides consulting project and design services to medical device and scientific industries. We are seeking a Product Development Engineer with minimum 3-5 years professional experience, to complement our existing team. The successful applicant will have experience in all life cycles stages of product design from initial concept through to design transfer into manufacturing.

As well as product design, the role will also require working with internal and external design teams to create product requirements from user needs, identifying product risk and harm; design verification and validation test protocols and reports; and product specifications. Experience working with overseas vendors would be viewed favourably as well as the willingness to learn new technologies and manufacturing processes.

Primary Responsibilities

1. Conceptualise and develop solutions with HFE, DFM/DFA and hazard mitigation as parallel considerations
2. Create product requirements from customer requirements
3. Organise supply and build of prototypes
4. Conduct feasibility tests on concept prototypes
5. Develop design verification and validation plans and conduct/participate in the protocols and reports
6. Creation of product and production specifications and process flows
7. Conduct hazards analysis and dFMEAs
8. Liaise with external laboratories for prototype testing
9. Transferring the design to manufacturing and assist the QA team with process and production validation activities
10. Follow company SOP’s during all phases of development and transfer to manufacture
11. Assist the management team with documentation required for regulatory submission

Required Skills and Knowledge

1. Bachelor of Mechanical/Industrial Design or Biomedical Engineering or equivalent, recognised by Engineers Australia
2. Min 3 years’ experience in Medical Device design (desired)
3. Experienced in CAD (Solidworks preferred) in a manufacturing environment
4. Writing skills, especially in creation of DHF and DMR documents.
5. Risk Analysis and Root Cause Analysis Techniques
6. Able to work independently and with multiple external stakeholders, including overseas vendors
7. Understanding of manufacturing techniques in plastics molding, metal fabrication and general manufacturing assembly
8. Excellent verbal communication skills
9. Customer/client facing skills and presentation are highly advantageous

Contact: careers@vestech.com.au

Vestech Pty Ltd provides consulting project and design services to medical and scientific industries. We are seeking a motivated individual to join our team as a Junior QA Engineer. The successful applicant will as a minimum completed an Honours Degree in Science, Technology or Engineering.

Role will be require working closely with the QA Manager to ensure the QMS complies with ISO 13485 and is audit ready; records evidencing the company’s compliance to the QMS created and maintained; Quality System improvements are implemented and effectiveness verified; documents are updated and released as per internal procedures; company technical documentation is kept current; and assist in internal and external audits.

Primary Responsibilities

1. Documentation Control, by supporting the composition, review, approval and release of documents. Ensure timely implementation & closure.
2. Work with QA Manager in the resolution of CAPAs, NCRs, customer feedback and complaints. Ensure timely implementation & closure.
3. Assist QA Manager in vendor management process, including audits and evaluation.
4. Coordinate the implementation of the company’s quality system, and associated records.
5. Ensure training is performed and recorded as per company procedures.
6. Ensure company records are maintained in traceable and readily accessible formats.
7. Assist the management team with documentation required for regulatory submission.

Required Skills and Knowledge

1. Honours Degree in Science, Technology or Engineering
2. Knowledge of ISO Quality Systems
3. Able to work independently and with multiple external stakeholders
4. Organised and has great attention to detail
5. Excellent English verbal and writing skills
6. Customer/client facing skills and presentation are highly advantageous

Contact: careers@vestech.com.au