Biomedical Engineer
Key information
Job ad expired
Workload:
100%Contract type:
Permanent positionPlace of work:
Route de Crassier 13, 1262 Eysins
Building on 30 years of experience in transfusion diagnostics, Quotient is a commercial stage diagnostics company committed to delivering solutions that reshape the way diagnostics is practiced. Quotient has two key product portfolios, Alba by Quotient and MosaiQTM by Quotient. The Alba by Quotient product range is comprised of high-quality reagents used to keep laboratories around the world running efficiently. They are sold directly to laboratories or through our OEM partners. MosaiQ™ by Quotient is our proprietary multiplex microarray technology, offering the world’s first fully automated, consolidated testing platform, allowing for multiple tests across different modalities. MosaiQ™ is designed to be a game-changing solution, which we believe will increase efficiencies, improve clinical practice, deliver significant workflow improvements and operational cost savings to laboratories around the world. Quotient’s operations are based in Eysins/Switzerland, Edinburgh/Scotland and Newtown/Pennsylvania.
Quotient is recruiting for a Biomedical Engineer to join the Systems Engineering Team based in Eysins. The role is a full-time and permanent position.
The Biomedical Engineer is responsible to understand the Assay workflow requirements for integration onto the MosaiQTM instrument; interpret the assay needs and develop associated design inputs for the Instrument, with specific focus on hardware and software development requirements. She/he will be responsible to lead continuous improvement initiatives on Instrument and Microarray.
JOB DESCRIPTION
The main responsibilities will include:
- Understand the needs of product assay workflow and develop associated Instrument design inputs
- Work directly with a third-party partner to develop instrument solutions to meet the design input needs
- Provide technical project management to ensure development solutions meet the internal stakeholder needs
- Ensure all development activities are in compliance with regulatory requirements, ensuring adherence to life cycle requirements
- Lead cross-functional project teams as required to deliver product improvements
- Participate in Design Reviews to ensure key milestone deliverables are achieved
- Lead and support risk management activities, including FMEA’s, to ensure robust and reliable designs
- Lead, develop and implement design characterization, DOE’s and design verification strategies
- Detailed understanding of medical device regulations including ISO, FDA GMP and design controls
QUALIFICATIONS & EXPERIENCE REQUIRED
- Primary Degree in Bio Mechanical Engineering / Electrical or Electro Mechanical Engineering
- Minimum 5 years’ experience in in IVD product development within GMP/GLP environment
- 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
- Excellent presentation and report writing skills
- Ability to demonstrate pro-activity, flexibility and reliability
- Proficiency in English, French or German an asset
Contact
- Laetitia STIRER