Inquis Medical

Clinical-stage thrombectomy system developer for VTE

Senior Director of Operations

Manufacturing & Production OperationsConfirmed live in the last 24 hours

Full-timeMenlo Park, CA, USA$210k - $250k

About the Job

Requirements

A bachelor's degree in Engineering, Operations Management, or a related field is required.
At least 10 years of operations leadership experience in the medical device industry.
Experience scaling manufacturing operations for Class II medical devices, preferably electrophysiology or minimally invasive cardiovascular devices.
Experience with single-use disposable sterile medical device and capital equipment production.
Experience in startup and high-growth environments.
Experience working within 21 CFR 820, 21 CFR Part 11, and/or ISO 13485-compliant quality systems.
Demonstrated success building material requirements planning systems and supply chain operations from an early stage.
Experience with direct-to-hospital sales and distribution models.
Deep knowledge of Good Manufacturing Practices and applicable quality system standards.
Ability to build and scale operations teams.
Thorough knowledge of materials and production scheduling systems, material requirements planning, and cycle counting.
Experience working within Food and Drug Administration and International Organization for Standardization-regulated environments.
Experience managing departmental budgets and profit-and-loss responsibility.
Experience complying with environmental health and safety regulations.
Proficiency with failure mode and effects analysis, design of experiments, statistical process control, and other problem-solving tools and statistical techniques.
Expertise interfacing with research and development and manufacturing groups to optimize device design and processes.
Strong project management and cross-functional collaboration skills.
Financial acumen with profit-and-loss responsibility experience.
Ability to present to the board and investors.
Strong negotiation skills with internal and external stakeholders.

Responsibilities

Develop and implement scalable manufacturing strategies for multiple Class II sterile disposable medical devices.
Establish strategic manufacturing partnerships and build internal production capabilities.
Evaluate external production capabilities.
Design and optimize production workflows to ensure quality, efficiency, and regulatory compliance; oversee sterile packaging and device sterilization processes.
Implement lean manufacturing principles and drive continuous improvement initiatives.
Build comprehensive material requirements planning systems from inception using NetSuite.
Develop 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.
Ensure manufacturing processes comply with Food and Drug Administration regulations for Class II medical devices.
Maintain quality management system standards ISO 13485, ISO 14971, ISO 10555, and ISO 10993.
Oversee quality control and quality assurance programs.
Support regulatory submissions and Food and Drug Administration interactions.
Build 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.
Develop operational budgets and cost models.
Implement cost reduction initiatives while maintaining quality standards.
Establish key performance indicators and operational metrics.
Support financial planning and investor reporting requirements.
Scale manufacturing and operations to increase production from 300 to 5,000 units per month and create distribution networks to support company growth.

Desired Qualifications

An MBA or advanced degree is preferred.
A previous Senior Director of Operations role in a medical device startup is strongly preferred.
Professional certifications such as ASQ, APICS, or PMP are a plus.

*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.

WhatYou'llWorkOn:

Manufacturing& ProductionLeadership

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

SupplyChain& SystemsDevelopment

Build comprehensive Material Requirements Planning (MRP) systems from inception using NetSuite
Develop 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& RegulatoryExcellence

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

TeamLeadership&OrganizationalDevelopment

Build 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

FinancialManagement&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

WhatYou'llContribute:

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)

ExperienceRequirements

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 environments
Experience 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

RequiredSkills&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 environments
Experience 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 USD

Inquis 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.

Compensation Range 210000 - 250000 USD

About the Company

Inquis Medical

Clinical-stage thrombectomy system developer for VTE

Inquis Medical is a clinical-stage medtech company developing the AVENTUS Thrombectomy System for non-surgical removal of blood clots in venous thromboembolic diseases. The system uses TrueClot tissue-sensing to give real-time feedback and distinguishes blood, clot, and vessel wall, while integrating navigation, aspiration, and a blood-return/filtration loop for single-pass clot removal with reduced blood loss. It differentiates itself with real-time tissue sensing, a single-pass approach, and an integrated blood filtration/return system that aims to improve precision and efficiency over existing devices. The company’s goal is to complete pivotal trials and commercially launch the AVENTUS system, initially for peripheral clots and later for pulmonary embolism, beginning with a 2025 market entry supported by a recent Series B round.

Company size: 51-200
Company stage: Series C
Total funding: $115M
Headquarters: Menlo Park, CA
Founded: 2019

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