• Location: Boston MA
• Type: Perm
• Job #26307

Company Overview:
A leading company in the medical device industry, is seeking a Senior Manager of Operations to oversee manufacturing operations and ensure compliance with industry standards.

Job Responsibilities:

• Lead day-to-day execution of manufacturing operations across internal production, contract manufacturing, and other operational areas.
• Drive execution across internal and external manufacturing partners, ensuring production readiness and schedule attainment.
• Develop and implement operational systems, processes, and governance to support business growth.
• Establish key performance indicators and improve manufacturing efficiency.
• Collaborate with various departments to support product introductions and continuous improvement initiatives.
• Ensure compliance with ISO 13485, FDA QSR, MDSAP, EU MDR, and other regulatory requirements.
• Conduct morning GEMBA walks and collaborate with Customer Service and Marketing.
• Provide operational support outside normal business hours when necessary.
• Assist in triage process for calls and complaints, and drive issue resolution.

Qualifications:

• Bachelor’s degree in a scientific or technical field or equivalent experience.
• Minimum of 5+ years of medical device manufacturing management experience.
• Experience with ISO 13485 compliant projects and manufacturing environments.
• Working knowledge of Lean Manufacturing Principles and Quality System elements.
• Familiarity with NetSuite or similar ERP, Excel, and data presentation.
• Proficiency in project management tools such as MS Project/Smartsheet.
• Availability to travel up to 10% when necessary.

Compensation:
Salary: $140,000 – $165,000