Sr. Director of Operations
inquis medicalEdison, NJ
$210,000 - $250,000 per yearAPPLY NOW (opens in a new tab)
Sr. Director of Operations
inquis medicalEdison, NJ
2 days ago
Occupations
General and Operations ManagersIndustrial Production ManagersFirst-Line Supervisors of Production and Operating WorkersIndustries
Surgical and Medical Instrument ManufacturingSurgical Appliance and Supplies ManufacturingElectromedical and Electrotherapeutic Apparatus Manufacturing$210,000 - $250,000 per year
APPLY NOW (opens in a new tab)About the role
Senior Director of Operations This position is on-site. If you are planning to relocate to the Bay Area please let us know in your cover letter or at the top of your resume. We are unable to offer relocation assistance for this position As Senior Director of Operations, you will lead our manufacturing and operations as they scale their innovative medical device solutions. This is a pivotal leadership role for a proven operations leader who thrives in high-growth environments and has deep expertise in medical device manufacturing. You will build and scale operations from the ground up in our facility to increase volumes from 300 - 5k a month; implementing a robust MRP system, and create distribution networks that will support our company's ambitious growth trajectory. Manufacturing & Production Leadership Develop and implement scalable manufacturing strategies for multiple Class II sterile disposable sterile medical devices. Establish strategic manufacturing partnerships and build internal production capabilities Build internal production capabilities and evaluate external production capabilities Design and optimize production workflows ensuring quality, efficiency, and regulatory compliance. Oversee sterile packaging and device sterilization processes. Implement lean manufacturing principles and drive continuous improvement initiatives Supply Chain & Systems DevelopmentBuild comprehensive Material Requirements Planning (MRP) systems from inception using NetSuiteDevelop sophisticated inventory management strategies for raw materials, components, and finished goods Create demand forecasting models and production planning processes Implement supply chain risk management and business continuity plans Quality & Regulatory Excellence Ensure all manufacturing processes comply with FDA regulations for Class II medical devices Maintain ISO 13485, 14971,10555 and 10993 quality management system standards Oversee comprehensive quality control and quality assurance programs Support regulatory submissions and FDA interactions Team Leadership & Organizational DevelopmentBuild and lead cross-functional operations teams including manufacturing, facilities, supply chain, and logistics Establish organizational structure and operational processes Develop talent acquisition strategies for critical operational roles Foster a culture of operational excellence and continuous improvement Financial Management & Strategy Develop operational budgets and cost models Implement cost reduction initiatives while maintaining quality standards Establish key performance indicators (KPIs) and operational metrics Support financial planning and investor reporting requirements
Education & Certifications:
- Bachelor's degree in Engineering, Operations Management, or related field (required)MBA or advanced degree (preferred)
- Professional certifications such as ASQ, APICS, or PMP (plus)
- Experience Requirements 10+ years of operations leadership experience in the medical device industry
- Previous Sr Director of Operations role in a medical device startup (strongly preferred)
- Proven track record scaling manufacturing operations for Class II medical devices, preferably EP or minimally invasive cardiovascular devices
- Experience with single-use disposable sterile medical device and capital equipment production
- Experience in startup and high-growth environmentsExperience working within 21 CFR 820, 21 CFR Part 11, and/or ISO 13485 compliant quality systems
- Demonstrated success building MRP systems and supply chain operations from early stage
- Experience with direct-to-hospital sales and distribution models
- Required Skills & Abilities
- Deep knowledge of Good Manufacturing Practices (GMP) and applicable Quality System Standards
- Proven ability to build and scale operations teams
- Thorough knowledge of materials and production scheduling systems, MRP, and cycle counting
- Experience working within FDA/ISO regulated environmentsExperience managing departmental budgets and P&L responsibility
- Experience complying with environmental health and safety regulations
- Demonstrated proficiency with problem-solving tools (FMEA, DOE, SPC, etc.) and statistical techniques
- Expertise interfacing with R&D and manufacturing groups to optimize device design and processes
- Strong project management and cross-functional collaboration skills
- Financial acumen with P&L responsibility experience
- Excellent communication skills with ability to present to board and investors
- Strong negotiation skills with internal and external stakeholders
Compensation Range $210,000 —$250,000 USDInquis Medical is an Equal Opportunity Employer and embraces diversity. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any characteristic protected by applicable law.
Inquis Medical does not accept resumes or candidate submissions from third-party recruiters and/or vendors who are not expressly under current written contract.
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JOB OVERVIEW
Salary
$210,000 - $250,000 per year
Experience level
Manager
Location
Edison, NJ
Occupation
General and Operations Managers
Industry
Surgical and Medical Instrument Manufacturing
Posted
2 days ago
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