Operations Manager

Job Title: Operations Manager

Job Description:

We're seeking an experienced Operations Manager to optimize our manufacturing operations, supply chain, and quality systems as we scale production of our medical device technology. This role will be critical in ensuring operational excellence while maintaining the highest standards of quality and regulatory compliance. This position will be on site 5 days a week with occasional travel to support 3PL and CM partners. The right candidate will lead the production team, kitting team, pick pack and ship and partner with our 3PL and CM partners.

Responsibilities:

Manufacturing & Production Operations

• Oversee day-to-day full operations for kitting, pick pack and ship and manufacturing, ensuring production targets are met while maintaining quality standards for all areas
• Develop and implement process improvements to increase efficiency, reduce waste, and lower costs
• Manage production scheduling, capacity planning, and resource allocation
• Drive continuous improvement initiatives using Lean, Six Sigma, or similar methodologies
• Monitor key performance indicators (KPIs) and implement corrective actions as needed
  
  

Supply Chain & Inventory Management

• Manage supplier relationships and vendor performance for critical components and materials
• Optimize inventory levels to balance working capital with production needs
• Develop contingency plans to mitigate supply chain risks and disruptions
  
  

Quality & Regulatory Compliance

• Ensure operations comply with FDA regulations, ISO 13485 standards, and other applicable requirements
• Partner with Quality Assurance to investigate and resolve production issues
• Support CAPA’s when required
• Support internal and external audits, maintaining documentation and records
• Implement and maintain quality management system procedures
  
  

Team Leadership

• Lead, develop, and mentor team members
• Foster a culture of accountability, safety, and continuous improvement
• Collaborate cross-functionally with R&D, Quality, Regulatory, and Finance teams
• Provide regular performance feedback and support professional development
  
  

Facilities & Infrastructure

• Oversee facility operations, maintenance, and equipment management
• Ensure safe working environment in compliance with OSHA and company safety policies
  
  

Process Improvement

• Identify and implement process improvements to enhance inventory accuracy and production efficiency
• Support system and process integrations between internal systems and external logistics partners
• Develop and maintain inventory and production KPIs, providing regular reporting to management
• Drive Lean six Sigma culture and 5s throughout the operations
  
  

Qualifications

Required:

• Bachelor's degree in Engineering, Operations Management, Supply Chain, or related field
• 5 years of operations management experience in medical device, pharmaceutical, or highly regulated manufacturing environment
• Strong knowledge of FDA regulations and ISO 13485 quality management systems
• Demonstrated experience with process improvement methodologies (Lean, Six Sigma, etc.)
• Proven track record of successfully scaling manufacturing operations
• Excellent analytical, problem-solving, and project management skills
• Strong leadership and interpersonal skills with ability to influence cross-functionally
• Experience with ERP/MRP systems and production planning tools
  
  

Preferred:

• Six Sigma Green Belt or Black Belt certification a plus
• Experience with contract manufacturing relationships
• Experience with 3PL management
• Background in Class II or Class III medical device manufacturing
  
  

What We Offer

$110,000/yr - $140,000/yr base salary Stock Options

We offer competitive compensation, benefits and a fantastic work environment:

• 95% paid Medical, Dental & Vision for employees and a generous subsidy for dependents
• 11 Paid Holidays and generous Time Off policies
• 401K Employer Match
• Paid parental leave policy
• Flexible Work from Anywhere Policy (if applicable to the role)
  
  

We have a strong healthcare-driven mission, and your guidance and efforts will directly link to our success. We embrace diversity and equal opportunity and are committed to building a team that represents a variety of backgrounds, perspectives, and skills. The more inclusive we are, the better our work will be for it.

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