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This position is responsible for managing and implementing the processes associated with the creation of new, and revision of existing, labeling content documents throughout the complete product lifecycle. This position partners with the appropriate groups and subject matter experts to drive product labeling development activities. The position is responsible for the accuracy of labeling documents and compliance with regulatory requirements, internal labeling processes and policies and associated change control. The position will be involved with participating in and responding to internal and external labeling audits, as well as activities related to the development and maintenance of applicable labeling procedures, guidelines, and templates. This position is responsible for partnering with multiple departments to manage and develop product structure and work instruction documents for manufacturing, warehouse and 3rd party distribution to correctly implement labeling on product. Additionally, this position is responsible for the development and delivery of training to pertinent functional units regarding labeling processes and supporting systems-based tools.
The Director, Quality Engineering is responsible for Quality teams, QA & QC, involved in producing and supporting our products. This role has responsibility for all quality operation activities related to manufacturing of Endologix products globally and for working with peer functions in Operations, Supply Chain, R&D, and Regulatory to identify quality engineering, assurance, and control strategies to ensure the highest quality standards for our products. In addition, this role is a key leader in the problem-solving process for issues affecting product and service quality.
Join Our Exciting Team as a Senior HR Generalist!
Endologix LLC is a California-based, global medical device company dedicated to improving patients’ lives by providing innovative therapies for the interventional treatment of vascular disease.
We have a therapeutic portfolio designed to treat diseases which currently have clinically relevant unmet needs. Our existing products can treat a wide spectrum of vascular disease through abdominal aortic aneurysms to lower limb peripheral vascular disease. We obtain excellent clinical outcomes through meticulous attention to product design, manufacturing, and training, all backed by industry-leading clinical evidence.
With a robust pipeline of disruptive technology, our vision is to provide physicians with the best device for each patient; because when it comes to ensuring patient well-being, we are never satisfied with the status quo.
Position Summary
The Senior Human Resources Generalist will work closely to support the talent agenda across Endologix. This role supports the employee lifecycle, beginning with the requisition process through offboarding. This is a dynamic position that responds to the needs of employee activity in the organization, involving everything from the employee requisition process, onboarding, employee safety and wellbeing, benefits, administering HR policies and procedures, and supporting HR initiatives and projects. The role will also partner with managers and employees to provide guidance on performance management, talent development, workforce planning and on-going strategic initiatives. This position is intended to be a steward of the employee experience at Endologix.
Design and develop manufacturing processes, tooling, and fixtures in order to meet daily production schedules while enhancing productivity and product quality.
Represents the Regulatory Affairs function in project teams, and manages regulatory projects to established timelines and budgets. Oversees and ensures compliance with state, federal and International medical device regulations and overall regulatory departmental objectives. Develops, prepares, and maintains domestic and international regulatory filings and documentation to meet corporate objectives.
Endologix develops and manufactures minimally invasive treatments for aortic disorders. We offer a dynamic, growth environment, competitive compensation and benefits, and a challenging, fulfilling experience in a fast-paced, growing
company. Medical device professionals have the opportunity to develop and further their careers in a dynamic company that features the latest innovations in endovascular aneurysm repair and sealing.
Job Scope:
Promotes, sells, and services the company’s stent graft directly to vascular specialists within an assigned geographic area in Oklahoma.
Endologix develops and manufactures minimally invasive treatments for aortic disorders and SFA disease. We offer a dynamic, growth environment, competitive compensation and benefits, and a challenging, fulfilling experience in a fast-paced, growing
company. Medical device professionals have the opportunity to develop and further their careers in a dynamic company that features the latest innovations in endovascular aneurysm repair and sealing.
Job Scope:
Promotes, sells, and services the company’s Detour System directly to vascular specialists within an assigned geographic area. Los Angeles metro area assigned geographic area.
Perform inspections, checks, tests, and sampling procedures of incoming materials, parts and components used in the manufacture of medical devices, partially assembled or finished medical devices. Perform review of Device History Records for release of finished goods.
Perform inspections, checks, tests, and sampling procedures of incoming materials, parts and components used in the manufacture of medical devices, partially assembled or finished medical devices. Perform review of Device History Records for release of finished goods.
Facilitate compliance to applicable internal and external requirements for the Design Control process. Collaborate with R&D, Regulatory, Clinical, Manufacturing, and other departments to help facilitate the successful execution of the Design Control and Risk Management processes. Accountable for Design Assurance Engineering deliverables required within the Design Control process.
Utilize personal experience and technical expertise to support the Clinical Analytics team as we analyze, interpret, and present clinical and non-clinical data to stakeholders. Plan and lead the development of statistical solutions, analyses in SAS or comparable statistical software, and support data management. Support legacy studies and make contributions to new clinical studies that build evidence supporting the therapy.
Endologix LLC is a California-based, global medical device company dedicated to improving patients’ lives by providing innovative therapies for the interventional treatment of vascular disease.
We have a therapeutic portfolio designed to treat diseases which currently have clinically relevant unmet needs. Our existing products can treat a wide spectrum of vascular disease through abdominal aortic aneurysms to lower limb peripheral vascular disease. We obtain excellent clinical outcomes through meticulous attention to product design, manufacturing, and training, all backed by industry-leading clinical evidence.
With a robust pipeline of disruptive technology, our vision is to provide physicians with the best device for each patient; because when it comes to ensuring patient well-being, we are never satisfied with the status quo.
Position Summary:
The Quality Control Inspector will perform inspections, checks, tests, and sampling procedures of incoming materials, parts and components used in the manufacture of medical devices, partially assembled or finished medical devices. This position will also perform review of Device History Records for release of finished goods.