LOCATION
Irvine, CA
TECHNOLOGY
Venous Thrombectomy
COMPANY HQ
Irvine, CA
COMPANY SIZE
1000+ Employees
POSITIONOVERVIEW
Inari Medical is the global leader in venous clot removal having developed three thrombectomy technology platforms for the treatment of venous thrombosis. Funded by prestigious venture capital firms, Gilde Healthcare, Versant Ventures, and U.S. Venture Partners, Inari debuted as the Best U.S. IPO of 2020 and generated $235M in revenue in 1H 2023 with a 31% increase from 2022. Oh, and Inari Medical is named after a piece of sushi…inari sushi. Inari is hiring their Head of Quality Engineering.
- Press: Inari in the News
- Revenue: Inari Q2 2023 Financials
- ClotTriever: The ClotTriever System
- FlowTriever: FlowTriever Retrieval/Aspiration System
We have partnered with Kit Cariquitan, Vice President of Quality Assurance and Regulatory Affairs, to hire our Head of Quality Engineering. This position will be a strategic and tactical leader across Quality Engineering groups while leading new product development and sustainment activities. This position will lead cross-functionally with R&D and Engineering teams ensuring risk management and design control processes are met while leading GAP remediations. Our Head of QE will also develop and manage a team.
POSITIONDETAILS
- Manages, through direct reports, the Quality Engineering department (activities with responsibility for results in support of the company’s Quality Management System).
- Hire, manage, develop, and support a high performing Quality Engineering team.
- Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance.
- Provide expertise and instruction in technical aspects of medical device and software related quality engineering including risk analysis, design verification, design validation, process validation, test method validation, data analysis and Software Development Life Cycle Management.
- Supports audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages of the audits.
- Participates in Management Reviews to provide oversight of the development and maintenance of quality engineering programs, systems, processes and procedures.
- Initiates document changes and creates procedures and instructions as required.
- Reviews document changes and design history for impact on specifications, product quality and compliance.
- Develop Quality Engineering department staff. Identify and develop associates with the potential to advance into leadership roles.
- Define Quality Engineering department goals and strategy for support activities associated with the development of medical devices, SaMD and SiMD.
- Comply with applicable Laws and Regulations, adhere to Quality Management System processes and requirements as well as demonstrate Ethics and Integrity in all matters and at all levels throughout the organization.
- Perform additional duties as assigned.
- Bachelor’s degree in technical or science related field preferred. Or, equivalent combination of education and experience to perform at this level.
- Excellent, proven interpersonal, verbal and written communication skills.
- Critical thinking skills and good judgment.
- Excellent working knowledge of design control process for medical devices, SaMD and SiMD.
- Excellent working knowledge of statistical analysis techniques and validation requirements.
- Proven skills in business and financial management
- Strong experience in the design, manufacture, and distribution of medical devices, SaMD and SiMD.
- Strong experience in design control and risk management for medical devices, SaMD and SiMD.
- Strong working knowledge of US and foreign standards and regulations related to: the design, manufacture, and distribution of medical devices, SaMD, SiMD and Quality systems.
- Experience participating in FDA and notified body inspections, especially in discussions related to design control activities.
- Experience in building highly effective Quality Engineering team involved in multiple product lines over multiple manufacturing facilities.
- Healthy disdain for the status quo
- Advanced abilities at reading and preparing technical documentation.
- Computer skills including but not limited to Word, Excel, PowerPoint and Internet experience.
- Must be living in, or willing to relocate to, Irvine, CA.
COMPANYOVERVIEW
Inari Medical, Inc. is a publicly traded medical device company dedicated to the development of innovative catheter-based technologies for the treatment of venous thromboembolism. Inari is focused on solutions that enable the safe removal of large clot volumes from big vessels without the use of thrombolytic drugs. Inari has developed three novel mechanical thrombectomy technology platforms.
The FlowTriever System has FDA clearance for the treatment of pulmonary embolism and for thrombectomy in the peripheral vessels. The ClotTriever System has FDA clearance for thrombectomy in the peripheral vessels. The InThrill System has FDA clearance for small vein and AV thrombectomy. Inari was founded in 2013 as a spin-out of Inceptus Medical, a medical device incubator.
View PDF
Company Overview
APPLY NOW
Senior Director, Quality Engineering
Irvine, CA
PRESENTED BY
Lifeblood™ supports global MedTech Startups with Talent Acquisition and Fundraising Strategies. We build full-scale startup teams from Board and C-level executives to entry-level individual contributors and from early-stage R&D through multi-national commercialization phases.Approaching two decades of experience in the MedTech industry, our talent acquisition services and team-building efforts are the results of 2,000+ successful hires for 500+ companies in 6 continents. We have facilitated more than $220 million for MedTech startups with our fundraising strategies and global investor network.
People and money are the lifeblood capital of startups. Learn from our entrepreneurs and investors as we demystify raising and investing capital on our MedTech Money Podcast Series.
