Senior Manufacturing Engineer

Senior Manufacturing Engineer – Respiratory & Cryogenic Systems

The Senior Manufacturing Engineer is responsible for the design, development, validation, and continuous improvement of manufacturing processes for oxygen concentrators and liquid oxygen (LOX) systems, including cryogenic storage and delivery devices.

This role is a hands-on, process-focused engineering position that ensures stable, efficient, and scalable production with a strong emphasis on zero line-down events, product quality, and throughput. The engineer partners closely with Design Engineering, Quality, and Operations to ensure manufacturable, robust product designs and production systems.

The ideal candidate is a proactive, detail-oriented, and technically curious problem solver who thrives on the production floor, uses structured methodologies such as DoE, process validation, and root cause analysis, and drives continuous improvement through data.

Key Responsibilities

• Design, develop, and implement robust manufacturing processes for oxygen concentrators and LOX systems (including cryogenic tank integration and handling).
• Lead process validation activities (IQ/OQ/PQ) to ensure processes meet performance, quality, and regulatory requirements.
• Define critical process parameters (CPPs) and establish process control strategies.
• Develop and maintain work instructions, process flows, and standard operating procedures (SOPs).
• Own manufacturing line performance with a focus on zero line-down events and rapid issue resolution.
• Provide real-time floor support, troubleshooting process, equipment, and yield issues.
• Lead root cause investigations (RCA) and implement effective corrective and preventive actions (CAPA).
• Monitor and improve yield, cycle time, scrap, and overall equipment effectiveness (OEE).
• Apply Design of Experiments (DoE) to optimize manufacturing processes and reduce variability.
• Conduct feasibility studies and process capability analyses (Cp/Cpk).
• Use statistical tools to drive data-based decisions and process improvements.
• Lead initiatives for cost reduction, throughput improvement, and process simplification.
• Partner with R&D and Design Engineering to ensure products are designed for manufacturability, assembly, and serviceability.
• Actively participate in design reviews, providing DFM/DFA input early in development.
• Support product transfers from development to production, ensuring smooth ramp-up and scalability.
• Specify, develop, and validate manufacturing equipment, fixtures, and test systems.
• Ensure equipment is capable, reliable, and aligned with process requirements and production volumes.
• Collaborate with suppliers and integrators for automation and capital equipment projects.
• Work closely with:
• Technicians and line operators to ensure practical, usable processes
• Supervisors and production leadership to maintain flow and efficiency
• Quality Engineering to ensure compliance and robust controls
• Supply Chain and suppliers for component readiness and process alignment
• Support global alignment across manufacturing sites (e.g., Ball Ground, Chengdu).
• Ensure manufacturing processes comply with:
• ISO 13485
• FDA Quality System Regulations (QSR)
• IEC 60601 / IEC 80601 (as applicable)
• Support risk management (PFMEA), control plans, and validation documentation.
• Maintain audit-ready documentation and support internal/external audits.
• Proactive Ownership: Takes initiative to prevent issues before they impact production.
• Hands-On Engagement: Actively present on the production floor; leads by doing.
• Technical Curiosity: Seeks to deeply understand processes, materials, and system interactions.
• Diligence & Rigor: Applies structured problem-solving (DoE, RCA, statistical methods).
• Team Collaboration: Builds strong relationships across engineering, operations, and production teams.
• Bias for Action: Responds quickly and effectively to production issues and changing priorities.

Competencies

• Manufacturing Process Engineering & Validation (IQ/OQ/PQ)
• Root Cause Analysis & CAPA
• Statistical Methods & DoE
• Production Line Optimization (OEE, yield, cycle time)
• DFM/DFA & Product Industrialization
• Equipment & Tooling Development
• Cross-Functional Leadership

Work Environment & Physical Demands

• Primarily manufacturing floor and lab environment, with some office work
• Frequent interaction with production lines, equipment, and operators
• Occasional lifting up to 50 lbs and travel as needed

Travel

Limited as needed

Required Education and Experience

• Bachelor’s or Master’s degree in Mechanical Engineering, Manufacturing Engineering, or related field
• 7+ years of experience in manufacturing engineering, preferably in medical devices or regulated industries
• Strong experience with:
• Process development, validation, and production support
• Hands-on troubleshooting in a manufacturing environment
• Statistical analysis and process control
• Working knowledge of:
• ISO 13485 and FDA QSR
• Process validation (IQ/OQ/PQ) and PFMEA

Preferred Education and Experience

• Experience with oxygen concentrators, respiratory devices, or LOX/cryogenic systems
• Familiarity with gas flow systems, pressure systems, and thermal/cryogenic behavior
• Experience with automation, assembly lines, and test systems
• Knowledge of Six Sigma / Lean manufacturing principles
• Experience with supplier process development and qualification

Additional Eligibility Qualifications

None required for this position.

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

We are committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status, or membership in any other class protected by federal, state, or local law.