Manufacturing Operations Specialist
The Operations Specialist plays a critical role in ensuring smooth and efficient operational processes within a medical device organization. This position supports production, inventory management, quality compliance, logistics, and engineering teams to meet regulatory standards and customer expectations. The ideal candidate will have strong organizational skills, attention to detail, and experience in a regulated environment.
Responsibilities:
- Monitor and maintain inventory levels for raw materials and finished products while coordinating with suppliers and vendors to ensure timely delivery of components.
- Assist engineers with operational needs related to product development and manufacturing.
- Provide timely data, documentation, and logistical support for engineering projects.
- Collaborate with engineering teams to implement process improvements and resolve technical challenges impacting operations.
- Ensure adherence to FDA and other regulatory requirements.
- Maintain accurate documentation for audits and inspections.
- Oversee order fulfillment, packaging, and shipping processes.
- Work with carriers to ensure timely and compliant delivery of products.
- Identify inefficiencies and recommend solutions to optimize workflows.
- Support the implementation of ERP systems and operational tools.
Essential Skills:
- Degree or 2+ years of experience in operations, preferably in medical devices or a regulated industry.
- Knowledge of FDA regulations and industry standards.
- Proficiency in ERP systems and Microsoft Office Suite.
- Strong analytical, organizational, and communication skills.
Additional Skills & Qualifications:
- Familiarity with Lean or Six Sigma methodologies.
- Experience with SAP or similar ERP platforms.
- Ability to work in a fast-paced, cross-functional environment.
Job Type & Location
This is a Permanent position based out of Saint Paul, MN.
Pay and Benefits
The pay range for this position is $32.00 - $32.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: Medical, dental & vision Critical Illness, Accident, and Hospital 401(k) Retirement Plan Pre-tax and Roth post-tax contributions available Life Insurance (Voluntary Life & AD&D for the employee and dependents) Short and long-term disability Health Spending Account (HSA) Transportation benefits Employee Assistance Program Time Off/Leave (PTO, Vacation or Sick Leave)
Workplace Type
This is a fully onsite position in Saint Paul, MN.
Application Deadline
This position is anticipated to close on May 25, 2026.