Job Description
Job Description
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 materialsOptimize inventory levels to balance working capital with production needsDevelop contingency plans to mitigate supply chain risks and disruptionsQuality & Regulatory Compliance
Ensure operations comply with FDA regulations, ISO 13485 standards, and other applicable requirementsPartner with Quality Assurance to investigate and resolve production issuesSupport CAPA’s when requiredSupport internal and external audits, maintaining documentation and recordsImplement and maintain quality management system proceduresTeam Leadership
Lead, develop, and mentor team membersFoster a culture of accountability, safety, and continuous improvementCollaborate cross-functionally with R&D, Quality, Regulatory, and Finance teamsProvide regular performance feedback and support professional developmentFacilities & Infrastructure
Oversee facility operations, maintenance, and equipment managementEnsure safe working environment in compliance with OSHA and company safety policiesProcess 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 field5+ years of operations management experience in medical device, pharmaceutical, or highly regulated manufacturing environmentStrong knowledge of FDA regulations and ISO 13485 quality management systemsDemonstrated experience with process improvement methodologies (Lean, Six Sigma, etc.)Proven track record of successfully scaling manufacturing operationsExcellent analytical, problem-solving, and project management skillsStrong leadership and interpersonal skills with ability to influence cross-functionallyExperience with ERP / MRP systems and production planning toolsPreferred :
Six Sigma Green Belt or Black Belt certification a plusExperience with contract manufacturing relationshipsExperience with 3PL managementBackground in Class II or Class III medical device manufacturingWhat 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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