Bio-Chemistry Engineer / Scientist
This is a permanent role within a high paced engineering team at Swords working on the next generation of medical diagnostics equipment. The position requires a candidate with a background in immunoassay and chemistry instruments. How they operate work and a good understanding of their assays.
Must have the ability to both support and troubleshoot system problems, test processes, lab processes and validate solutions to enhance product and process capability in a highly regulated environment.
The role will require the incumbent to act as a technical lead and key decision maker in supporting current instrument install base and manufacturing of medical diagnostic instrumentation with a bias towards Chemistry and Immunoassay instruments and assays.
The incumbent must have the ability to structure, plan, prioritize, and deliver their own work, and that of the team.
The incumbent will report to a Principal Engineer and will be a member of the site level Engineering Team at Swords.
1) Key member of a team who provides technical support to field service and the production line in the manufacturing of medical instrumentation product platforms in a low volume, high complexity, highly regulated technology environment in IVD Instrumentation.
2) Analyze problems to root cause with a structured approach and fully develop solutions, including all associated planning of engineering changes and design verification activities.
3) Developing and re-engineering test processes to build robustness & reduced cost.
4) Report writing for Verification and Validation plans / report to verify technical solutions to enhance product and process capability with a focus on test processes but overlapping to assembly. Areas include wet test specification, data analysis, system test design, test system support.
5) Complete Risk Assessments / Reports assist in troubleshooting field complaints.
6) Owner of Chemical lab processes (storage / preparation of assay / reagents, serum, samples and dilutions). Act as a best practice trainer setting robust standards for staff operating in these areas.
7) Participate in the continuous development of the quality system, including standard operating procedures (SOP's), laboratory requirements, workflow development, product and process validations coupled with the ability to write concise technical reports.
Qualifications/Skills/Experience for this role:
- Minimum of bachelor’s degree in relevant technical Scientific or Engineering discipline (Biochemistry, Chemistry, Life Sciences). Qualification in alternative disciplines may be considered if balanced by relevant experience.
- 3-5 years’ experience in a medical devices laboratory with good working knowledge of Immunoassay / Chemistry instruments and their associated assays is a must.
- Must be familiar with good laboratory practices (sample handling, assay storage etc.)
- Excellent communications skills with ability to write technical and quality documents in a clear and structured manner, (procedures, verification plans, reports)
- Strong statistical and data analysis experience is required. Knowledge of different statistical packages, capability analysis, statistical process control and DOE.
Location(s): Swords Co Dublin