Manufacturing & Operations Specialist
Nuwellis, Inc.
Summary
Nuwellis is a medical device company dedicated to improving the lives of patients with fluid overload. Our Aquadex SmartFlow system helps healthcare providers remove excess fluid when medications alone aren't enough. We're looking for a Manufacturing Operations Specialist to connect our internal teams with external manufacturing partners and help keep products moving from production to customers. This hands-on role combines manufacturing support, sustaining engineering, supplier coordination, and inventory management.
Job description
About the Role
Nuwellis is a medical device company dedicated to improving the lives of patients with fluid overload. Our Aquadex SmartFlow system helps healthcare providers remove excess fluid when medications alone aren't enough. We're looking for a Manufacturing Operations Specialist to connect our internal teams with external manufacturing partners and help keep products moving from production to customers. This hands-on role combines manufacturing support, sustaining engineering, supplier coordination, and inventory management.
Contract Manufacturing & Supplier Support
- Serve as a primary day-to-day contact for contract manufacturing partners.
- Monitor manufacturing schedules, inventory levels, and product availability.
- Coordinate production activities to support customer demand and business objectives.
- Track orders, inventory, and purchasing activities through the ERP system.
- Support supplier process improvement and manufacturing optimization efforts.
- Help troubleshoot manufacturing issues and coordinate resolution activities.
- Coordinate activities related to product continuity, component availability, and manufacturing changes.
- Participate in investigations, corrective actions, and continuous improvement initiatives.
- Build strong working relationships with suppliers and manufacturing partners.
Sustaining Engineering & Technical Support
- Support continuation engineering, sustaining engineering, and product lifecycle management activities.
- Partner with the Manufacturing Engineer to support manufacturing, quality, and engineering initiatives.
- Coordinate engineering changes with internal teams and external manufacturing partners.
- Assist with manufacturing process improvements and documentation updates.
- Support implementation of product and process changes.
- Identify alternatives for obsolete materials and components.
- Assist in evaluating manufacturing issues, nonconformances, and process improvements.
- Support validation, testing, and product implementation activities as needed.
Operations, Receiving & Distribution Support
- Coordinate receiving activities for products and materials.
- Perform visual inspections of incoming products and materials to verify packaging integrity, labeling, quantity, and documentation accuracy.
- Review incoming shipments against purchase orders, packing slips, and receiving records.
- Maintain receiving, inspection, and inventory records in accordance with established procedures.
- Maintain inventory accuracy and product traceability within the ERP system.
- Support product distribution and fulfillment processes.
- Assist with inventory control activities, cycle counts, and warehouse organization.
- Help ensure products move through established receiving, quarantine, and distribution processes.
- Support shipping and logistics activities as needed.
Cross-Functional Operational Support
- Provide backup support for customer service, order fulfillment, shipping, receiving, and inventory management activities.
- Assist with order processing and operational transactions within the ERP system when needed.
- Support cross-functional projects and process improvement initiatives.
- Help maintain operational efficiency through effective communication and coordination across teams.
Requirements
- 3-5 years of experience supporting contract manufacturing, manufacturing operations, sustaining/continuation engineering, supply chain, or a related technical environment
- Experience working with contract manufacturers, suppliers, or outsourced manufacturing partners
- Experience supporting manufacturing operations, sustaining engineering, or product lifecycle activities
- Strong organizational and project coordination skills
- Experience using ERP systems
- Excellent communication and problem-solving abilities
- Ability to manage multiple priorities and adapt in a fast-paced environment
- Proficiency with Microsoft Office applications, including Excel
- Preferred: Medical device industry experience
- Preferred: Experience supporting contract manufacturing organizations (CMOs) or regulated manufacturing environments
- Preferred: Experience with engineering change management, CAPA, nonconformance investigations, or quality system processes
- Preferred: Experience with incoming receiving, inventory control, distribution, or warehouse operations
- Preferred: Knowledge of product lifecycle management and sustaining engineering practices
- Preferred: Bachelor's degree in Engineering, Operations, Supply Chain, Manufacturing, or a related technical field
Benefits
- Health Insurance
- HSA Contribution
- Dental & Vision Coverage
- Life Insurance
- Short & Long-Term Disability
- PTO
- Floating Holidays
- 8 Company Holidays
- 401(k) 3% Match
Company overview
Nuwellis, Inc. is a medical technology company specializing in fluid management solutions for patients with fluid overload conditions. The company's flagship product is the Aquadex SmartFlow® system, an ultrafiltration device designed to remove excess fluid from patients suffering from heart failure, chronic kidney disease, and other conditions that cause fluid retention. The Aquadex system provides a more controlled and gentle fluid removal process compared to traditional diuretic therapy, making it particularly valuable for patients who are diuretic-resistant or have complex fluid management needs. Nuwellis focuses on developing innovative technologies that improve patient outcomes in critical care, heart failure, and nephrology settings. The company's solutions are designed to address the significant clinical challenge of fluid overload, which affects millions of patients worldwide and is associated with increased hospitalizations and healthcare costs. Nuwellis operates in the medical device sector with a commitment to advancing fluid management through precision medical technology.