Description Who We Are: binx health is a healthcare technology and diagnostics company focused on expanding access to care. The binx io is the world’s first FDA-cleared, CLIA-Waived, point-of-care platform for chlamydia and gonorrhea testing in both males and females. Our rapid, molecular platform brings rapid, accurate and convenient infectious disease testing to clinical settings nationwide. binx everywhere is our technology platform that provides the necessary tools to connect your community with convenient diagnostic testing programs through self-collected samples, high-quality laboratory partnerships, and a full continuum of clinical care where and when it’s convenient for them. Our solutions have the ability to broaden access to care for millions and put proprietary testing solutions in the hands of clinicians everywhere. We work with universities, hospitals, clinics, public health departments, k-12 schools, employers, and other organizations to provide patient-centric solutions for their communities. At binx health, we know a diverse workforce adds to our collective value and strength as an organization. People of colour, the LGBTQIA community, disabled candidates and veterans are strongly encouraged to apply. binx health is proud to be an Equal Opportunity Employer, committed to equal employment opportunity and fair, equitable compensation regardless of race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. The Position: We are looking for a Design Engineer to join our team at an exciting time of rapid growth. The ideal candidate will be a Mechanical Engineering graduate with several years 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. Some travel will be required for the role. Responsibilities: Maintenance of the mechanical aspects of the DHF and MDF CAD administration, structuring PDM system, creating and maintaining workflows, drawing templates etc. Modification to product design models and drawings under change control conditions Documentation generation and update under change control Process ECR’s, both internal and external from contract manufacturers Product failure investigation including testing and reporting Create, update and maintain DFMEA’s Take part in root cause analysis investigations Support production engineering activities as we scale operations Liaise and troubleshoot technical issues with contract manufacturers Support to internal and external Audit activities Ensure quality requirements are met as manufacturing is scaled and processes optimised for volume and cost reduction Following QMS procedures Education, Experience and Demonstrated Skills : A Bachelor's degree in Mechanical Engineering. Chartered status or desire to achieve membership of a recognised professional body Qualifications Essential CAD experience, ideally Solidworks with PDM Generic engineering documentation including specification/protocol writing Ability to diagnose and solve technical and/or system problems of a high degree of complexity DMS configuration management Stage gate development methodology Change control DFMEA experience Commercial experience in dealing with suppliers Familiarity with requirements traceability tools and techniques Familiarity with product Verification and Validation processes Desirable Experience working in an FDA and/or ISO 13485 environment Experience with Design Transfer to CMO’s Experience in developing and/or the manufacture of IVD diagnostic products Experience using SharePoint / Teams SAP ERP Root cause Analysis tools and techniques Process validation, IQ, OQ, PQ planning and execution Strong level of computer literacy and the use of word processing, spreadsheets, databases, graphics, statistics, engineering tools and programming