Senior Design & Process Engineer

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 gonorrhoea testing in both males and females. Our rapid, molecular platform brings rapid, accurate and convenient infectious disease testing to clinical settings nationwide. 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.

Our Values:

We are… Bold – Tenacious – One Team – Fixated on Our Mission

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.

JOB DESCRIPTION:

As the Senior Design and Process Engineer you will be working as part of a team focused on scaling up and enhancing our cartridge manufacturing capability which includes the detailed assessment of product data, materials characterisation, detailed process analysis and redesign. The role holder will work as part of a project team with our manufacturing third parties to find innovative data driven solutions consistently working to improve the product quality, production capacity and reduce cost. The role will involve travel to meet with contract manufacturing and supply partners to collaborate on work aligned to these project goals. They will also lead quality improvement activities and suggest innovative solutions to technical problems.

Responsibilities:

• The role holder will acquire a detailed understanding of the technical aspects of the process and the equipment and facilities.
• Implement, monitor, and drive the improvement of key business metrics designed to drive improvements in quality, production efficiency and cost.
• Actively look to introduce manufacturing process improvements.
• Develop stable and capable manufacturing processes through a structured process development approach.
• Analyse data gathered in QC from cartridge run data.
• Design & develop tools, fixtures, gauges, and special equipment for manufacturing operations.
• Work with third parties to develop process automation solutions.
• BinX technical review of validation documentation at CMO’s.
• Preparation of all relevant product specifications and specification updates.
• Support process start-up activities through generation of the relevant documentation.
• Manage and seek approval for all engineering change (change control, change management) for the product and ensure that this is appropriately communicated on site. Close out all change controls in a timely fashion.
• Lead/participate in rigorous technical risk assessments and investigations for plant changes/product introduction.
• Monitor process yield and actively look to continuously improve yield.
• Key technical liaison with contract manufacturers.
• Work with binx engineering team to maintain consistency of product across manufacturers.
• Troubleshoot and investigate errors and faults, lead root cause analysis and plan remedial actions.
• Additional responsibilities may be added to the above as determined by line manager.