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 an experienced and motivated Engineering Manager to join our Point of Care Engineering team. This role will influence process characterization, materials characterization and focus on improving our manufacturing process including the automation of manufacturing. This individual will develop, implement and maintain methods, operation sequences, and processes within our manufacturing department. They will lead and manage product and process engineers in coordinating the release of new operating procedures, executing manufacturing automation and transfer activities, new products introductions (NPI), as well as estimate manufacturing cost, determines time standards and make recommendations for tooling and process requirements of new/existing products.
- Develop, implement and maintain methods, operation sequences, and processes in the manufacturing or fabrication of parts, components, sub-assemblies, and final assemblies.
- Interface with Research & Development in coordinating the release of new products.
- Estimate manufacturing costs and determine time standards for product launch/deployment.
- Responsible for maintaining records and reporting systems for coordination of manufacturing operations.
- Act as a manufacturing strategic leader: Develop manufacturing processes by studying product requirements; performing gauge R&R studies; researching, designing, modifying, and testing manufacturing methods and equipment; conferring with equipment vendors.
- Lead or recommend analysis and research of new business practices or approaches.
- Responsible for planning and directing all aspects of engineering activities related to assigned projects.
- Analyzing product performance data in a meta-analysis approach to define product and process improvements that will enhance key business metrics (complaints, yield, waste, etc.) 6-sigma experience and qualification would be advantageous
- Ensures all engineering projects, initiatives and processes are in conformance with the organization’s established policies and objectives.
- Proactively anticipates framework and infrastructure requirements.
- Demonstrate leadership characteristics to move the organization toward long-term business goals through a culture of openness, empowerment, and innovation.
- Resolves and consults on most complex issues and drives solutions.
- Sponsor and/or manage Lean Activities, and improve manufacturing efficiency by analyzing and planning workflow, space requirements, and equipment layout.
- Assures product and process quality by designing testing methods; testing finished product and process capabilities; establishing standards; confirming manufacturing processes.
- Line management of the engineering team which may include product, process, and quality engineers.
Education, Experience, and Demonstrated Skills
- BS or MS college degree in mechanical engineering or related experience.
- 3 + years of related management and manufacturing experience.
- 6 + or more years of related experience in medical devices.
- Sound knowledge/experience of federal and other regulations governing medical device assembly and design such as GMP, QSR, ISO, and CMDR.
- Recognized expert in multiple technological fields of specialization.
- Strong knowledge of manufacturing processes including working with plastics. Mechanical /electrical and/or software engineering experience desirable.
- Demonstrable understands of product design, verification, and validation, manufacturing, and testing activities.
- Typical computer application includes Solid Works, AutoCAD, MS Word, Excel, and Project. May include Lab View, PLC, and other specialty machine and vision SW.
- Demonstrated problem-solving and troubleshooting skills
- Previous management experience leading a team of high-performing manufacturing engineers.
- Self-starter that can influence internal/external customers.
binx health, Inc. is an Equal Opportunity Employer
For interested applicants, please submit resumes to: firstname.lastname@example.org