Operations Engineer

Operations Engineer

We are seeking a dedicated Operations Engineer to execute comprehensive labeling implementation plans for both new and existing medical devices. This role is pivotal in ensuring the timely release of product and package labeling across all Quality System documentation.

Responsibilities

• Develop and execute comprehensive labeling implementation plans for new and existing medical devices.
• Ensure the timely release of product and package labeling across all Quality System documentation.
• Collaborate with Regulatory teams to maintain and update the Global Labeling Requirements document to align with applicable medical device labeling standards and regulations.
• Coordinate and perform web posting of approved labeling and maintain the e-labeling website in compliance with regulatory requirements.
• Work with localization vendors to manage the translation and localization of all product and package labeling, ensuring accuracy and cultural relevance.
• Provide backup support for the creation and maintenance of product labels and perform labeling verification activities.

Essential Skills

• Experience with medical device digital labeling.
• Knowledge of regulatory standards for medical device products, particularly digital standards for device use, device packaging, and quality systems.
• Understanding of product localization.
• Experience with the electronic document management system IQVIA SmartSolve.
• Bachelor's Degree in Engineering or a related field.

Additional Skills & Qualifications

• Experience in Quality Assurance.
• Knowledge of Loftware Cloud.
• Understanding of SAP.
• Experience with document management systems.

Pay and Benefits

The pay range for this position is $40.00 - $60.00/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 remote position.

Application Deadline

This position is anticipated to close on Oct 10, 2025.