Manufacturing Process Engineer - Sibel Health : Job Details

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 seeking a proactive and detail-oriented Manufacturing Process Engineer to join our dynamic operations team. In this role, you will play a critical part in scaling manufacturing processes, ensuring high quality and efficient production of our advanced medical technology products. You will work cross-functionally with R&D, quality, and supply chain teams while also guiding contract manufacturing partners to translate prototypes into production-ready builds.

WHAT YOU WILL BE WORKING ON:

Technical Leadership & Training

• Act as the lead technical expert for all manufacturing processes across platforms.
• Train and mentor technicians, ensuring effective knowledge transfer and consistent execution of processes.
• Develop and maintain technical training programs and certification protocols for production staff.

Validation & Quality Systems Ownership

• Own and manage the Master Validation Plan, Process Failure Modes and Effects Analysis (PFMEA), and other key validation documents.
• Lead and support process qualification activities (IQ/OQ/PQ) in compliance with ISO 13485, FDA, and other regulatory requirements.
• Drive risk assessments 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.

Continuous Improvement & Root Cause Analysis

• Drive production yield improvements and cost reductions through data-driven root cause analysis and structured problem-solving (e.g., 8D, DMAIC).
• Implement Lean Manufacturing principles and Six Sigma tools to streamline workflows and reduce process variation.

New Product Introduction (NPI) & Scale-Up

• Serve as the bridge between product development and manufacturing, ensuring smooth transitions from pilot builds to full-scale production.
• Develop and scale new manufacturing processes in collaboration with Contract Manufacturers (CMs), ensuring repeatability and control.
• Oversee equipment specification, procurement, installation, and validation.

Supplier & CMO Engagement

• 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:

• Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Industrial Engineering, or a related technical field.
• 2–5 years of hands-on experience in a regulated manufacturing environment, preferably in medical devices or electronics.
• Strong understanding of validation methodologies, quality systems (ISO 13485, FDA QSR), and GMP requirements.
• Experience with Lean/Six Sigma, PFMEA, and root cause methodologies.
• Proficiency with CAD, Minitab/JMP, MES, and ERP systems is a plus.
• Excellent communication and cross-functional collaboration skills.

Preferred Certifications (Optional but Beneficial)

• 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.