A Senior Systems Engineer is required by CareerWise Recruitment for our client based in the North West of Dublin City. The Senior Systems Engineer is responsible to understand the Assay workflow requirements for integration onto IVD instrumentation; interpret the assay needs and develop associated design inputs for the Instrument, with specific focus on hardware. Subsequently supporting instrument development, assay integration and verification / validation activities. The role is also responsible for leading product variability / improvement initiatives on Instrument and Microarray. Please contact Tom Devaney for more information.
Role of this position
- Understanding the needs of product assay workflow and develop associated Instrument design inputs
- Working directly with a third-party partner to develop instrument solutions to meet the design input needs and ensuring they meet key milestones and timelines
- Leading project teams and providing technical project management to meet internal stakeholder needs
- Ensuring all development activities are in compliance with regulatory requirements, ensuring adherence to life cycle requirements
- Development and implementation of design characterization, DOE's and design verification strategies
- Detailed understanding of Medical Device regulations including ISO, FDA GMP and design controls
- Primary Degree in Bio Mechanical Engineering / Electrical or Electro Mechanical Engineering
- Experience in Medical Device product development supported by relevant IVD business understanding
- Strong working knowledge of electromechanical design, requirements definition and V&V activities.
- Manufacturing experience in a medical device / IVD manufacturing environment with specific emphasis on improvement methodologies
- Flexibility to travel required, primarily in Europe. Travel requirements will vary but typically will be 20% of the time. Due to the nature of the role, some travel is at short notice.
Please call Tom Devaney today for further information on 091-758771 or email: email@example.com
CareerWise Recruitment (In Search of Excellence)