Instrument Development Engineer
|Title||:||Instrument Development Engineer|
|Sector||:||IT / Software
Engineering & Technical
Scientific & Laboratory
Role of this position
- Interpret the assay needs and develop associated design inputs for the Instrument.
- Support instrument development, Assay Integration and Validation & Verification activities.
- Collaborate with all internal functional stakeholders, to ensure solutions developed meet the commercial, regulatory and functional performance needs, defined as product requirements.
- Provide technical project management to ensure development solutions meet the internal stakeholder needs.
- Participate in Design Reviews to ensure key milestone deliverables are achieved.
- Lead and support Risk Management activities, including FMEAs, to ensure robust and reliable designs.
- Lead, develop and implement design characterisation, DOEs and design verification strategies for efficient.
- Complete and robust testing through report completion and anomaly resolution or independently perform tolerance, error budget or other design analysis by extending or adapting existing methodologies.
- Clear understanding of Medical Device regulations including ISO, FDA GMP and Design Controls.
- Clearly understand Risk Management; use Risk Management tools and techniques to develop solutions.
- Degree in Bio Mechanical Engineering / Electrical or Electromechanical Engineering
- Significant level of applicable industry experience is required
- Strong experience in development of complex, sophisticated, Software Controlled Electromechanical Medical Devices / IVD Instruments
- Must be very capable of communicating in a clear and concise manner, independent and innovative thinker with excellent presentation and report writing skills
- Fluent in English, German is a distinct advantage
- Flexibility to travel up to 50% of time. Some travel is on short notice
Please call Tom Devaney today for further information on +353 - 91-758771 or email: firstname.lastname@example.org
CareerWise Recruitment (In Search of Excellence)
Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the Medical Devices, Pharmaceuticals, Life Sciences, ICT, Engineering, Food and Agri sectors.
We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin.