Manufacturing Process Engineer
Posted on November 19, 2025 (3 minutes ago)
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®. Founded with focus on vulnerable patients—pregnant persons and babies—leveraging wireless monitoring. They provide advanced wireless wearables, software, and AI/ML algorithms linked to the cloud, launched in 20 countries. Collaborate with healthcare organizations worldwide, including major philanthropies and medical technology firms.
The Opportunity:
Seeking a proactive and detail-oriented Manufacturing Process Engineer to join operations. Role involves scaling manufacturing processes, ensuring quality and efficient production of advanced medical devices. Collaborate cross-functionally and guide contract manufacturing partners for production readiness.
What You Will Be Working On:
Technical Leadership & Training
- Lead technical expert for manufacturing processes across platforms.
- Train and mentor technicians for knowledge transfer and consistent execution.
- Develop and maintain training programs and certification protocols.
Validation & Quality Systems Ownership
- Manage Master Validation Plan, PFMEA, and validation documents.
- Lead process qualifications (IQ/OQ/PQ) complying with ISO 13485, FDA regulations.
- Drive risk assessments and root cause investigations for non-conformance.
Process Documentation & Control
- Create, revise, and control build instructions, SOPs, and work instructions.
- Maintain documentation for manufacturing consistency and audits.
Design for Manufacturability & Test (DFM/DFT)
- Collaborate to optimize product design for manufacturability, scalability, testability.
- Lead initiatives to improve test coverage, reduce cycle time, and enhance diagnostics.
Continuous Improvement & Root Cause Analysis
- Drive yield improvements and cost reduction through root cause analysis (8D, DMAIC).
- Implement Lean Manufacturing and Six Sigma to improve workflows and reduce variation.
New Product Introduction (NPI) & Scale-Up
- Bridge product development and manufacturing for smooth pilot-to-production transition.
- Develop and scale new manufacturing processes with Contract Manufacturers.
- Oversee equipment specification, procurement, installation, validation.
Supplier & CMO Engagement
- Work with CMOs to define processes, resolve issues, ensure product delivery.
- Participate in audits, technical reviews, readiness assessments.
Data Analysis & Reporting
- Monitor process metrics and generate reports for decisions.
- Use statistical process control (SPC) and analytical tools for process improvement.
Equipment Maintenance & Calibration
- Maintain and execute maintenance and calibration plans for production and test equipment.
- Ensure compliance with calibration schedules and documentation.
About You:
- Bachelor’s degree in Mechanical, Biomedical, or Industrial Engineering or related field.
- 2–5 years experience in regulated manufacturing environment, preferably medical devices or electronics.
- Knowledge of validation methodologies, ISO 13485, FDA QSR, GMP requirements.
- Experience with Lean/Six Sigma, PFMEA, root cause analysis methodologies.
- Proficiency with CAD, Minitab/JMP, MES, ERP systems is a plus.
- Excellent communication and cross-functional collaboration skills.
Preferred Certifications (Optional)
- Six Sigma Green Belt or Black Belt
- Certified Manufacturing Engineer (CMfgE)
- ASQ Certified Quality Engineer (CQE)
Benefits:
- Medical, dental, vision, life, and disability insurance.
- Flexible "Take as much time as you need" policy.
- Simple IRA plan with employer matching.
- Company-sponsored events and lunches.
- Professional development stipend.
- Opportunity to be part of a dedicated, mission-driven team revolutionizing wireless monitoring.
- Work in a fast-paced, dynamic global environment with shifting priorities.
Sibel Health Inc. is an equal opportunity employer. All qualified applicants will be considered without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.
Please apply via LinkedIn by clicking the 'Apply' button on the job posting page.