Who we are

binx health has the world’s fastest FDA-cleared molecular platform for CT/NG testing for male and female samples. We also have a broad suite of offerings in sample collection for large corporate partners for broadened access to STI and COVID-19 care. Our molecular point of care platform brings rapid, accurate, and convenient infectious disease testing to people where they live, work, and shop. Our solutions offer front-end engagement, and end-to-end logistics in concert with our reference lab partners to offer partners “turn-key” answers for their infectious disease testing needs. Our solutions broaden access to care for millions and put proprietary testing solutions in the hands of clinicians everywhere, including in the ever-expanding footprint of retail health. Our suite of medical guideline-driven sample collection and laboratory testing solutions for STIs and COVID-19 are designed to reach the many who are unwilling or unable to visit a physical location.

The Position

We are looking for an NPI Engineer to join our team at an exciting time of rapid growth. The ideal candidate will be an Engineering graduate with some industrial experience in a regulated industry such as medical or aerospace. The basic product design is complete and we are now preparing for full-scale production and field support of our diagnostic instrument.

Responsibilities

• Creating the product V&V strategy
• Writing V&V test protocols
• Assisting with product testing and writing V&V test reports
• Maintenance of the V&V aspects of the DHF and MDF
• Production Engineering support
• Supporting root cause analysis (RCA)
• Technical liaison with suppliers and subcontractors
• Following QMS procedures

Education, Experience, and Demonstrated Skills

Required

• A Bachelor's degree in engineering or equivalent medical device experience.
• Specification/protocol writing
• Experience of product Design Verification
• Medical device V&V testing methodologies
• Test method development
• DMS configuration management

Desirable

• Familiarity with requirements traceability tools and techniques
• Familiarity with programming methodologies
• Experience working in an FDA and/or ISO 13485 environment
• Knowledge of IEC 62304
• Ability to diagnose and solve technical and/or system problems of a high degree of complexity
• Experience in developing and/or the manufacturing of IVD diagnostic products
• Experience using SharePoint / Teams
• SAP ERP
• Root cause analysis tools and techniques
• DFMEA & PFMEA experience
• Strong level of computer literacy and the use of word processing, spreadsheets, databases, graphics, statistics, engineering tools and programming.

binx health, Ltd. is an Equal Opportunity Employer For interested applicants, please submit resumes to careers@mybinxhealth.com