Who We Are
binx health has the world’s fastest FDA-cleared molecular platform for CT/NG testing. We also have the broadest suite of offerings in at-home testing 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 at-home 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, at-home testing solutions for STIs and COVID-19 are designed to reach the many who are unwilling or unable to visit a physical location.
We are looking for a Product & Process Engineer to join our team at an exciting time of rapid growth. The successful candidate will be will working as part of a team focused on scaling up and enhancing our PCR cartridge manufacturing capability which includes the deployment of new automation, materials characterization, 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 suggests innovative solutions to technical problems.
- 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.
- Design & develop tools, fixtures, gauges, and special equipment for manufacturing operations.
- Work with third parties to develop process automation solutions.
- Compile and execute validation protocols for process changes
- Design, document, and conduct process validations as required ensuring effective legal manufacturer oversight is maintained.
- Preparation of all relevant manufacturing specifications.
- 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. Closeout all change controls in a timely fashion.
- Lead/participate in rigorous technical risk assessments and investigations for plant changes/product introduction.
- Process Automation / scaleup
- 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.
Education, Experience, and Demonstrated Skills
- A relevant Bachelor's degree in an engineering discipline or equivalent medical device experience.
- Experience in process validation.
- Medical device or similar industry Experience with demonstrated experience with FDA and ISO 13485 – change management and risk management
- cGMP Experience
- Gauge R&R
- Root cause Analysis
- Experience in manual and automation techniques is essential.
- Six Sigma
- Capability Studies
- Experience in developing and/or the manufacture of products in an IVD diagnostic
- General understanding and experience in injection molding and other component manufacturing techniques (printing, sheet component conversion, adhesives) are very beneficial.
- General understanding of molecular biology, focusing on PCR and sample preparation would be beneficial
- Management of engineering projects and/or personnel
- Ability to diagnose and solve technical and/or system problems of a high degree of complexity
- Knowledge of electronic, mechanical and/or computer reengineering design and applications principles.
- Knowledge of clinical systems architecture used for medical device interoperability
- Strong level of computer literacy and the use of word processing, spreadsheets, databases, graphics, statistics, engineering tools and programming.
- CAD – ideally Solidworks
binx health, Inc. is an Equal Opportunity Employer
For interested applicants, please submit resumes to firstname.lastname@example.org