Sibel Health
Base pay range
$117,000.00/yr - $130,000.00/yr
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 seeking a proactive, detail‑oriented, and technically autonomous
Senior Manufacturing Process Engineer
to join our dynamic operations team. This is a senior‑level role for an individual capable of making independent judgment calls in a fast‑paced environment. You will play a critical role in scaling manufacturing processes to ensure the high‑quality, efficient production of our advanced medical technology products. You will work cross‑functionally with R&D, quality, and supply chain teams while technically leading contract manufacturing partners to translate prototypes into production‑ready builds.
WHAT YOU WILL BE WORKING ON:
Technical Leadership & Training
Electronics Expertise : Act as the lead technical expert for manufacturing processes with a specific focus on electronics, PCBA, and electromechanical assembly.
Mentorship : Train and mentor technicians and junior engineers, ensuring effective knowledge transfer and consistent execution of processes.
NPI Scale‑Up : Serve as the bridge between product development and manufacturing, ensuring smooth transitions from pilot builds to full‑scale production with Contract Manufacturers (CMs). Oversee equipment specification, procurement, installation, and validation.
Validation & Quality Systems Ownership
End‑to‑End Ownership : Own and manage the Master Validation Plan, serving as the primary strategist rather than just a contributor.
Execution : Independently lead process qualification activities (IQ/OQ/PQ) in compliance with ISO 13485 and FDA requirements, ensuring deep technical rigor in protocols and acceptance criteria.
Risk Management : Drive risk assessments (PFMEA) and root cause investigations for process‑related non‑conformances.
Process Documentation & Control
Create, revise, and control detailed build instructions, standard operating procedures (SOPs), and work instructions.
Maintain comprehensive documentation across all product lines to ensure consistent manufacturing practices and audit readiness.
Design for Manufacturability & Test (DFM/DFT)
Collaborate with R&D and test engineering teams to optimize product design for manufacturability, scalability, and testability.
Lead initiatives to enhance test coverage, reduce test cycle time, and improve diagnostic accuracy in both functional and in‑line testing.
Structured Problem Solving : Drive production yield improvements and cost reductions by rigorously applying data‑driven root‑cause analysis (e.g., 8D, DMAIC) rather than merely conceptual troubleshooting.
Process Optimization : Implement Lean Manufacturing principles and Six Sigma tools to streamline workflows and reduce process variation.
Design for Manufacturability (DFM) : Collaborate with R&D to optimize product design for manufacturability, scalability, and testability, specifically regarding test coverage and diagnostic accuracy.
Collaborate closely with contract manufacturing organizations (CMOs) to define process requirements, resolve issues, and ensure timely product delivery.
Participate in supplier audits, technical reviews, and readiness assessments.
Data Analysis & Reporting
Monitor process metrics (e.g., cycle time, yield, throughput) and generate regular reports to inform operational decision‑making.
Utilize statistical process control (SPC) and other analytical tools to maintain and improve process capability.
Equipment Maintenance & Calibration
Own and execute maintenance and calibration plans for all production and test equipment.
Ensure compliance with calibration schedules and proper documentation to meet quality and regulatory requirements.
ABOUT YOU:
Education : Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, Electrical Engineering, or a related technical field.
Experience : 5+ years of hands‑on experience in a regulated manufacturing environment.
Required Technical Skills : Direct experience with electronics, PCBA, and test manufacturing is needed.
Validation Depth : Proven experience owning Master Validation Plans and executing IQ/OQ/PQ end‑to‑end (not just participating as a team member).
Regulatory Knowledge : Strong understanding of quality systems (ISO 13485, FDA QSR) and GMP requirements.
Autonomy : Demonstrated ability to act as a self‑starter, making independent decisions and judgment calls in ambiguous situations without constant coaching.
Analytical Rigor : Proven proficiency with Lean/Six Sigma methodologies and statistical tools (Minitab/JMP) for root cause analysis.
PREFERRED BUT NOT REQUIRED:
Six Sigma Green Belt or Black Belt
Certified Manufacturing Engineer (CMfgE)
ASQ Certified Quality Engineer (CQE)
BENEFITS:
Medical, dental, vision, life, and disability insurance.
“Take as much time as you need” policy.
Simple IRA plan with employer matching.
Company‑sponsored events and lunches.
Stipend for professional development.
Opportunity to be part of a dedicated and driven team that is here to disrupt and revolutionize wireless monitoring.
Capability to work in a fast‑paced, dynamic global environment with multiple changing priorities.
Sibel Health Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.
Seniority level
Mid‑Senior level
Employment type
Full‑time
Job function
Manufacturing and Engineering
Industries
Medical Equipment Manufacturing
#J-18808-Ljbffr
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 seeking a proactive, detail‑oriented, and technically autonomous
Senior Manufacturing Process Engineer
to join our dynamic operations team. This is a senior‑level role for an individual capable of making independent judgment calls in a fast‑paced environment. You will play a critical role in scaling manufacturing processes to ensure the high‑quality, efficient production of our advanced medical technology products. You will work cross‑functionally with R&D, quality, and supply chain teams while technically leading contract manufacturing partners to translate prototypes into production‑ready builds.
WHAT YOU WILL BE WORKING ON:
Technical Leadership & Training
Electronics Expertise : Act as the lead technical expert for manufacturing processes with a specific focus on electronics, PCBA, and electromechanical assembly.
Mentorship : Train and mentor technicians and junior engineers, ensuring effective knowledge transfer and consistent execution of processes.
NPI Scale‑Up : Serve as the bridge between product development and manufacturing, ensuring smooth transitions from pilot builds to full‑scale production with Contract Manufacturers (CMs). Oversee equipment specification, procurement, installation, and validation.
Validation & Quality Systems Ownership
End‑to‑End Ownership : Own and manage the Master Validation Plan, serving as the primary strategist rather than just a contributor.
Execution : Independently lead process qualification activities (IQ/OQ/PQ) in compliance with ISO 13485 and FDA requirements, ensuring deep technical rigor in protocols and acceptance criteria.
Risk Management : Drive risk assessments (PFMEA) and root cause investigations for process‑related non‑conformances.
Process Documentation & Control
Create, revise, and control detailed build instructions, standard operating procedures (SOPs), and work instructions.
Maintain comprehensive documentation across all product lines to ensure consistent manufacturing practices and audit readiness.
Design for Manufacturability & Test (DFM/DFT)
Collaborate with R&D and test engineering teams to optimize product design for manufacturability, scalability, and testability.
Lead initiatives to enhance test coverage, reduce test cycle time, and improve diagnostic accuracy in both functional and in‑line testing.
Structured Problem Solving : Drive production yield improvements and cost reductions by rigorously applying data‑driven root‑cause analysis (e.g., 8D, DMAIC) rather than merely conceptual troubleshooting.
Process Optimization : Implement Lean Manufacturing principles and Six Sigma tools to streamline workflows and reduce process variation.
Design for Manufacturability (DFM) : Collaborate with R&D to optimize product design for manufacturability, scalability, and testability, specifically regarding test coverage and diagnostic accuracy.
Collaborate closely with contract manufacturing organizations (CMOs) to define process requirements, resolve issues, and ensure timely product delivery.
Participate in supplier audits, technical reviews, and readiness assessments.
Data Analysis & Reporting
Monitor process metrics (e.g., cycle time, yield, throughput) and generate regular reports to inform operational decision‑making.
Utilize statistical process control (SPC) and other analytical tools to maintain and improve process capability.
Equipment Maintenance & Calibration
Own and execute maintenance and calibration plans for all production and test equipment.
Ensure compliance with calibration schedules and proper documentation to meet quality and regulatory requirements.
ABOUT YOU:
Education : Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, Electrical Engineering, or a related technical field.
Experience : 5+ years of hands‑on experience in a regulated manufacturing environment.
Required Technical Skills : Direct experience with electronics, PCBA, and test manufacturing is needed.
Validation Depth : Proven experience owning Master Validation Plans and executing IQ/OQ/PQ end‑to‑end (not just participating as a team member).
Regulatory Knowledge : Strong understanding of quality systems (ISO 13485, FDA QSR) and GMP requirements.
Autonomy : Demonstrated ability to act as a self‑starter, making independent decisions and judgment calls in ambiguous situations without constant coaching.
Analytical Rigor : Proven proficiency with Lean/Six Sigma methodologies and statistical tools (Minitab/JMP) for root cause analysis.
PREFERRED BUT NOT REQUIRED:
Six Sigma Green Belt or Black Belt
Certified Manufacturing Engineer (CMfgE)
ASQ Certified Quality Engineer (CQE)
BENEFITS:
Medical, dental, vision, life, and disability insurance.
“Take as much time as you need” policy.
Simple IRA plan with employer matching.
Company‑sponsored events and lunches.
Stipend for professional development.
Opportunity to be part of a dedicated and driven team that is here to disrupt and revolutionize wireless monitoring.
Capability to work in a fast‑paced, dynamic global environment with multiple changing priorities.
Sibel Health Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.
Seniority level
Mid‑Senior level
Employment type
Full‑time
Job function
Manufacturing and Engineering
Industries
Medical Equipment Manufacturing
#J-18808-Ljbffr