JOB DESCRIPTION – Manufacturing Engineer (Instrumentation) 12 MONTH CONTRACT
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 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.
Qualifications
Role and Responsibilities:
binx Health is looking for a skilled manufacturing engineer to design, implement, monitor, and maintain manufacturing processes and work instructions within the medical device industry.
Key Responsibilities include:
- Evaluate manufacturing processes and workflows to identify areas that could benefit from changes and improvements, through interfacing with line operators, component vendors and key suppliers.
- Support verification and validation activities of manufacturing line at CMO, ensuring appropriate testing suites, including in line process controls, are identified and implemented for our product
- Apply working knowledge of product design and assembly to the manufacturing process
- Maintain manufacturing process documentation, including technical reports (e.g., process capability studies), BOM, process specifications in line with regulatory and quality assurance requirements.
- Create processes and procedures to help the company meet performance quotas
- Design systems and equipment that reduce time, cost and improve quality and safety
- Work with design engineers to improve product design for ease of manufacturing and assembly.
- Ensure products and sub-assemblies can be manufactured reliably and perform consistently
- Manage projects using engineering principles and techniques
Required Experience
- Proven experience in medical device or diagnostics manufacturing, owning and improving manufacturing processes in a regulated industry (e.g., medical devices, diagnostics, or similar).
- Experience supporting manufacturing transfer, scale-up, and production in collaboration with CMOs or external partners.
- Experience working with suppliers and cross-functional teams, including design engineering and quality.
- Demonstrated experience maintaining manufacturing documentation within a Quality Management System (e.g., ISO 13485).
- Hands-on experience with process development, troubleshooting, and continuous improvement initiatives.
- 5+ years’ experience in a regulated industry where Quality Systems are essential, e.g., ISO 13485.
Required Skills:
- Familiarity with Design for Manufacturability (DFM) and Design for Assembly (DFA) principles.
- Knowledge of manufacturing methods relevant to instrumentation or electromechanical assembly.
- Ability to design and implement efficient, scalable manufacturing processes.
- Strong understanding of verification and validation (V&V), including process validation and in-line testing strategies.
- Strong and demonstrated analytical and problem-solving skills, with a hands-on approach to troubleshooting and experimentation
- Excellent verbal and written communication, and teamwork skills.
- Capable of managing projects with minimal supervision.
