Senior Manufacturing Engineer

Paragonix Technologies markets organ transportation devices that safeguard organs during the journey between donor and recipient patients. Our devices incorporate clinically proven and medically trusted hypothermic preservation techniques in a novel suspension system to provide unprecedented physical and thermal protection. Our product portfolio spans cardiac, thoracic, and abdominal preservation devices to improve donor organ quality and extend donor organ transport time. Paragonix also markets transplant services and organ screening to the transplant community.

Position Overview: As Senior Manufacturing Engineer, you will assume a pivotal role within the Manufacturing and Supply Chain Team. You will be responsible for leading process improvement initiatives, optimizing manufacturing operations, and ensuring product quality and efficiency. This role involves collaborating with cross-functional teams (RD, Quality, Sustaining) to develop and implement product changes and advanced manufacturing techniques, support new product introductions, and drive continuous improvement in the production process across all products.

Primary responsibilities/authority will include:

1. Process Optimization Continuous Improvement:
   • Analyze current manufacturing processes to identify inefficiencies, bottlenecks, and opportunities for improvement.
   • Develop and implement strategies to reduce cycle time, scrap, and overall production costs while maintaining quality standards.
   • Drive Lean Manufacturing initiatives, including Kaizen events and Value Stream Mapping.
2. Validation Documentation:
   • Develop, review and approve validation protocols and (IQ/OQ/PQ) and reports for manufacturing processes, equipment, and software systems in compliance with ISO 13485 and FDA requirements.
   • Ensure all validation activities and documentation comply with ISO 13485, FDA 21 CFR Part 11/820, and applicable GMP requirements.
   • Lead and review any changes to process documentation, SOPs, and work instructions.
3. Collaboration with Contract Manufacturers/Vendors:
   • Work closely with contract manufacturers to implement engineering changes, monitor process capability (Cp/Cpk), and ensure compliance with ISO 13485 and supplier quality agreements.
   • Provide technical support and guidance to ensure alignment with company standards and product specifications; oversee any process-related investigations.
4. New Product Introduction (NPI):
   • Support design for manufacturability (DFM) and design for assembly (DFA) during product development phases.
   • Develop and validate manufacturing processes for new products, including tooling and equipment requirements.
   • Support coordination of pilot runs and ensure smooth transition to full-scale production.
5. Data Analysis Reporting:
   • Collect and analyze production data to monitor process performance and identify trends.
   • Prepare reports and present findings to management with actionable recommendations.
   • Conduct root cause analysis and implement corrective and preventive actions (CAPA) for production defects.

Education and Experience:

• Bachelor’s degree in Mechanical, Industrial, or Manufacturing Engineering.
• 5+ years of experience in manufacturing engineering, preferably in a high-volume or complex production environment.
• Demonstrated track record of success in process development and Lean Manufacturing/Six Sigma methodologies.

Skills and Competencies:

• Advanced knowledge of manufacturing processes such as injection molding, CNC machining, and complex assembly.
• Proficiency in CAD/CAM tools (e.g., SolidWorks) and familiarity with GDT principles.
• Strong background in Lean Manufacturing, Kaizen, and Six Sigma methodologies.
• Proficiency statistics tools (e.g., Minitab, JMP).
• Ability to conduct time studies, capacity analysis, and implement takt time improvements.
• Strong project management skills, with the ability to manage multiple projects simultaneously and drive initiatives to completion on time and within budget.
• Ability to analyze complex data sets to identify possible trends and root causes; expertise in failure mode and effects analysis (FMEA).
• Knowledge of medical device regulatory submissions (e.g., supporting DHF, DMR updates); familiar with ISO 9001 and ISO 13485 standards and requirements.
• Excellent communication and interpersonal skills for collaboration with cross-functional teams.
• Ability to work under time constraints and adapt to changing priorities in a fast-paced environment.
• Willingness to travel occasionally, as needed, to visit manufacturing partners, vendors, and processing facilities to support investigations or process changes.

Additional Qualifications:

• Six Sigma Green Belt or Black Belt.
• Certified Manufacturing Engineer (CMfgE).
• Background in medical devices.
• Experience with cleanroom manufacturing and/or knowledge of sterilization processes.

Salary range is $115,000- $135,000 based on experience