Manufacturing & Operations Specialist

Nuwellis•Eden Prairie, MN

About The Position

Nuwellis is a medical device company whose Aquadex SmartFlow system helps healthcare providers remove excess fluid when medications alone are not enough. The Manufacturing Operations Specialist connects internal teams with external manufacturing partners and helps move products from production to customers. This hands-on role combines manufacturing support, sustaining engineering, supplier coordination, and inventory management, with work that may include resolving supply chain issues, coordinating product changes, and troubleshooting manufacturing challenges. The role supports contract manufacturing partners, production schedules, inventory and product availability, supplier improvement, engineering changes, product continuity, and manufacturing process improvements. It also supports receiving and inspection, inventory accuracy and traceability, distribution and fulfillment, shipping and logistics, and operational transactions using the ERP system. The specialist coordinates across teams and suppliers, participates in investigations and continuous improvement, and provides backup for customer service and related operational activities.

Requirements

  • 3–5 years of experience supporting contract manufacturing, manufacturing operations, sustaining or 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.

Nice To Haves

  • Medical device industry experience.
  • Experience supporting contract manufacturing organizations (CMOs) or regulated manufacturing environments.
  • Experience with engineering change management, CAPA, nonconformance investigations, or quality system processes.
  • Experience with incoming receiving, inventory control, distribution, or warehouse operations.
  • Knowledge of product lifecycle management and sustaining engineering practices.
  • Bachelor's degree in Engineering, Operations, Supply Chain, Manufacturing, or a related technical field.

Responsibilities

  • 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 product continuity, component availability, and manufacturing change activities.
  • Participate in investigations, corrective actions, and continuous improvement initiatives.
  • Build working relationships with suppliers and manufacturing partners.
  • Support continuation engineering, sustaining engineering, and product lifecycle management activities.
  • Partner with the Manufacturing Engineer on 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.
  • Coordinate receiving activities for products and materials.
  • Perform visual inspections of incoming products and materials for packaging integrity, labeling, quantity, and documentation accuracy.
  • Review incoming shipments against purchase orders, packing slips, and receiving records.
  • Maintain receiving, inspection, and inventory records according to established procedures.
  • Maintain inventory accuracy and product traceability in the ERP system.
  • Support product distribution and fulfillment processes.
  • Assist with inventory control, cycle counts, and warehouse organization.
  • Help ensure products follow established receiving, quarantine, and distribution processes.
  • Support shipping and logistics activities as needed.
  • Provide backup support for customer service, order fulfillment, shipping, receiving, and inventory management.
  • Assist with order processing and operational transactions in the ERP system when needed.
  • Support cross-functional projects and process improvement initiatives.
  • Help maintain operational efficiency through communication and coordination across teams.

Benefits

  • $35–$40 per hour, depending on relevant experience and qualifications.
  • Multiple health insurance plan options, including a high-deductible health plan with an annual company HSA contribution of $2,000 for individual coverage or $4,000 for family coverage.
  • Company contribution toward dental and vision coverage.
  • Employer-paid life insurance of up to 1X annual salary.
  • Paid short- and long-term disability.
  • PTO, floating holidays, and 8 company holidays.
  • 401(k) plan with a 3% company match.
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