A BIT ABOUT SIBEL HEALTH:
With headquarters based in Chicago, Illinois and an international office in Seoul, South Korea, Sibel Health is an award-winning digital health startup with a mission to deliver Better Health Data for All®. We were founded with a specific focus on our most vulnerable patients—pregnant persons and babies—where we believe wireless monitoring has the potential to do the most good worldwide. We achieve this by providing a complete monitoring solution of advanced wireless wearables, best in class software, and novel AI/ML algorithms all linked to the cloud. To date, we've launched our technologies in 20 countries from the most advanced hospitals in the world to the most resource constrained locations. We work with some of the most respected healthcare organizations in the world from major philanthropies to large medical technology and pharmaceutical companies. With numerous FDA clearances and a recently completed fundraising round, we are poised for growth and expansion. We are seeking mission-driven individuals with a strong sense of purpose who believe that technology can improve the lives of our most vulnerable patients.
THE OPPORTUNITY:
We are looking for a Sr. Manufacturing Process Engineer to join our team. You will work with Quality, Design Engineers, Manufacturing Engineers, Project Managers, Product Managers and other cross-functional teams to react quickly and support the manufacturing and supply chain function. Sibel's fast-paced environment offers ample opportunities for growth in several areas: improved technology skills, effective leadership, dedicated mentorship, creative design, strong communication skills, teamwork, and more.
This is a full-time position. The salary range for this role is $100,000 - $120,000, depending on level of experience.
WHAT YOU WILL BE WORKING ON:
- LSR/ Injection Molding/PCBA CM Process Support
- General GMP oversight
- Mfg Process Controls Development
- Maintenance Support
- Support ECR approval
- Support NPI Stage Gate Development
- Support Quality Initiatives and GEMBA CI
- Support Process Related NCMR, CAPA and Regulatory Agency Audits
- Calibration & PM Support
- Scheduling and Recording of Calibration and maintenance of Critical Instruments
- Compression Molding / Adhesive Assembly / Electrical Assembly Manual Processes
- Support ABI, WI, IR and WO Development and Maintenance of In-House Processes
- Support Transfer
- PFMEA Development and Maintenance
- Process Development and Optimization Support
- Support URS, Design Specification, FAT and SAT
- Support IQOQ and PPQ/PQs/TMVs
- Mfg Excellence
- ASQ LSS Geen Belt
- Mfg and Packaging Process Flow
- Value Stream Map Development
- GEMBA Walks
- Mfg Documentation Creation and Maintenance
- Packaging Documentation Creation and Maintenance
- Supporting new product development as required
ABOUT YOU:
- 5-10 years PCBA, Injection Molding, LSR, conversion and manual assembly process and inspection systems experience.
- BS in Mechanical Engineering, Electrical Engineering, Chemical Engineering or Electrical Engineering/Computer Science.
- 5+ years supporting medical device manufacturing from new product development to mass production.
- Experience working with PCBA SMT and Injection Molding or LSR contract manufacturers, preferably for high mix low volume products.
- Knowledge of multiple manufacturing domains with technical acumen critical to the success of the role: SMT equipment, soldering methods, resins, software verification tools, AOI, X-Ray inspection systems (AXI), Injection Molding or LSR mold tooling and automated loading and inspection systems, plastic film or laminate film manufacturing, packaging equipment and processes including pouching, carton equipment, labeling and laser marking systems, etc.
- Successful track record of developing manufacturing process documentation and supporting validating the process in a dynamic environment and achieving repeatable results.
- Experience with Solidworks 3D CAD.
- Experience using quality electronic documentation systems (EDMs), Veeva, MasterControl, etc.
- Proficient in MS Office Software such as Excel, Word, and Outlook.
- Working knowledge of Six Sigma and root-cause tools, Minitab experience is a plus.
- Capability to work in a fast-paced, dynamic global environment with multiple changing priorities.
YOU MAY THRIVE IN THIS ROLE IF:
- Have supported development to commercialization of medical devices per FDA 21 CFR Part 820, ISO 14971 and ISO 13485 regulations.
- Have previous high mix low volume PCBA assembly process experience.
- Have previous start-up company experience.
- Are a self-starter.
BENEFITS:
- Medical, dental, vision, life, and disability insurance.