At Epredia, we improve lives by enabling better cancer diagnostics. We are a team of talented individuals with diverse backgrounds and expertise, working together to develop precision diagnostic solutions for our customers. We are a fast growing global company that drives innovation in diagnostics to create better outcomes for patients. Joining Epredia is much more than a job- it is an opportunity to be part of something with a purpose. Find out how you can improve lives while advancing your career.
You will become the Verification Engineer supporting Epredia Existing Product Development by planning environment and executing robustness testing for hardware, software and integrated systems. You will liaise with EPD, project and marketing teams to identify and develop the verification strategy for design changes in existing Epredia products.
Builds verification strategies and testing protocols for proposed changes in existing design specifications: materials, electronics, software or integrated system.
Actively participates in risk management meetings related to hazard/harm analysis and FMEAs.
Provides expertise in risk management and analysis techniques including statistical techniques.
Provides expertise in evaluating design changes for impact to existing Design Inputs, Design Outputs and Design Verification.
Develops testing principles for functional, reliability and durability testing.
Utilizes adequate and latest testing methodologies and standards.
Develops new test equipment or redesign existing using best practice engineering techniques.
Ensures tools, methodologies and testing standards are appropriately applied to achieve project aims.
Ensures the DHF are complete and up to the current external and internal standards.
A degree in engineering or science discipline preferred
Experienced in definition of functional system requirements, requirements traceability and flow down.
Familiar with test and integration methods for hardware and software product designs.
Understanding and experience with Design Controls 21 CFR 820 and ISO 13485:2016, Risk Management ISO14971:2012 associated with the medical device industry.
Proven experience with FMEA, FTA and reliability analyses.
Adherence to a formal Change Control quality system.
Proven ability to critically evaluate proposed study designs
Strong knowledge of statistics, the calculation of sample sizes and/or estimation of statistical power.
Electrical, EMC, RED Safety and Environmental Standards compliance experience.
What we offer:
Funded private healthcare or health cash plan as preferred
Life Assurance policy (4 x basic salary)
Pension scheme via salary sacrifice
Employee Assistance Program
Many voluntary benefits
Access to Discount scheme
Epredia offers a wide variety of competitive compensation and benefits programs. If you meet the requirements of this unique opportunity, and are driven by innovation and the desire to improve the lives of our patients, we encourage you to apply now. Job postings will remain open for a minimum of five business days and are subject to immediate closure thereafter without additional notice.