Magellan Robotic System

Career Opportunities

Regulatory Affairs Associate / Senior Associate

Summary:

This position is responsible for regulatory product submissions and regulatory compliance activities. Develops and maintains domestic and international submissions. Reviews international and domestic labeling and product design documentation ensuring compliance with regulatory requirements. Provides regulatory guidance to cross-functional teams.

Essential Functions:

  • Prepares, submits and maintains domestic and international regulatory submissions
  • Participate in cross functional teams for development projects
  • Provide support to currently marketed products, e.g., review engineering changes, labeling, promotional material, product changes and documentation for compliance and for changes requiring regulatory agency approval
  • Responsible for regulatory review & approval of non-conforming product
  • Provides regulatory guidance as needed
  • Develop and maintain regulatory procedures and policies to ensure ongoing compliance of existing and new products
  • Other duties as assigned

Requirements:

  • Bachelor’s Degree and minimum of 3-9 years related professional experience; equivalent combination of education and experience
  • Knowledge of current FDA regulatory requirements and trends for medical device Premarket Notifications
  • Knowledge of software, capital equipment and disposable product design practices
  • Experience with electro-mechanical and sterile disposable products. Familiar with product biocompatibility, sterilization and packaging requirements
  • Knowledge of ISO / MDD and Canadian regulatory requirements
  • Ability to influence and work with personnel at all levels and functional boundaries
  • Ability to represent Regulatory Affairs in multiple environments (i.e., Marketing, R&D, etc.)
  • A self-starter with the ability to work independently and as part of a team
  • Good prioritizing, organization, interpersonal, communication and analytical skills
  • Good computer skills with knowledge of Microsoft Office

Hansen Medical, Inc. is an Equal Opportunity Employer

Please apply using the following link: 
https://home2.eease.adp.com/recruit/?id=8945492

Regional Sales Executive (RSE) - Seattle Region

Summary:

A Hansen Regional Sales Executive (RSE) will be accountable for selling the Sensei X System to new and existing hospitals within the Regional Sales Executive's assigned territory. This requires a number of capabilities including expert-level comprehension in the use of flexible robotics, the ability to assemble a team of advocates within each hospital, strong solution selling skills, and tenacity to assure sales objectives are met on a consistent basis.

Essential Functions:

  • Regional Sales Executives are expected to provide an extraordinary degree of information gathering and presenting to buying teams throughout the capital equipment purchasing process 
  • Market development and sales of the Hansen Sensei X and all related disposable products as well as any future products developed under the Hansen Medical brand
  • Understanding the Hansen product line and effectively delivering all corporate marketing messaging to prospects and customers at a high level
  • Effectively delivering sales presentations to senior hospital executives, department middle management, lab staff, physicians and materials management
  • Organizing and supporting on site product demonstrations
  • Execution of the sales process from prospect and market development to purchase order
  • Administrative responsibilities include, but are not limited to, forecasting, product quotation, account development and management, customer correspondence, development of sales support collaterals as well as general reporting functions, establishing and maintaining an account data base in conjunction with Hansen’s CRM product and utilizing it strategically to develop their territory
  • Attending and supporting regional and national trade shows and meetings upon request
  • Managing a 50% travel schedule across a multiple state geography
  • Guiding, directing, motivating and working cooperatively with the Clinical Sales Representatives (CSR), Clinical Support Specialists (CSS), and working cooperatively with Customer Support Engineers (CSE)

Requirements:

  • Proven sales success achieving consistent annual sales performance in the top 20% of their sales organizations
  • Strong entrepreneurial skills to manage a typical start-up situation quickly adapt to a rapidly changing environment outside and inside the firm and successfully realize the company’s outstanding growth potential
  • Outstanding ability to market and sell technically complex products
  • Effectively manage the sales process to achieve quarterly sales targets; work independently and when appropriate with Clinical Sales Representative to create a lead pipeline, manage concurrent activities and track status of activities
  • Effectively introduce Clinical Sales Team to all key hospital personnel to ensure an effective account transfer
  • A minimum of 5 years sales experience in 2 of 3 disciplines: medical capital equipment and medical device, including medical catheter sales
  • Strong written and oral communication skills and strong presentation and demonstration skills
  • Strong organizational and time management skills
  • Creative thinking, problem solving, self motivation and the ability to function autonomously
  • Bachelor’s Degree (BS or BA)

Hansen Medical, Inc. is an Equal Opportunity Employer

Please apply using the following link: 
https://home2.eease.adp.com/recruit/?id=7603972

Clinical Trials Specialist

Summary:

The Clinical Trials Specialist position provides support to the clinical department to assist with the execution of clinical studies and maintenance of clinical files.  Follows standard operating procedures and supports the creation and revision of clinical trial processes.

Essential Functions:

  • Exercise independent judgment with respect to clinical studies
  • Maintain clinical operations files and study master files, including the creation and management
  • Refine FDA auditable documents
  • Independently communicates in a timely and accurate manner with study sites
  • Establishes, maintains, and updates various databases for clinical tracking
  • Sets-up, tracks, and maintains audit ready, incoming and outgoing regulatory documents for study sites
  • Prepares materials for various clinical and in-house meetings(coordinates meeting and may take meeting minutes)
  • Responsible for ordering and preparing supplies in coordination with all phases of the clinical studies as well as maintaining the tracking system for and inventories of all study-related supplies
  • Ensures the timely shipment of all study materials (including protocols, study logs, study binders, etc.) and oversees returns and in-house reconciliation
  • May be responsible for extracting/exporting the results of studies, test results and data entry
  • Reviews and processes vendor/site payments
  • Provide input to clinical processes
  • Actively build relationships with departments and management to create a collaborative environment
  • Other tasks, as assigned by the project lead

Requirements:

  • Bachelor’s degree in the health sciences or equivalent experience
  • 3-5 years experience in clinical research coordination
  • Proactive, accountable with excellent organizational, project management and prioritization skills
  • Excellent verbal and written communication skills
  • Demonstrated strong Microsoft Office and computer skills
  • Ability to multitask and prioritize competing priorities

Hansen Medical, Inc. is an Equal Opportunity Employer

Please apply using the following link: 
https://home2.eease.adp.com/recruit/?id=11448442

Senior Clinical Research Associate

Summary:

Hansen Medical is a global leader in flexible medical robotics.  Our innovative technology provides physicians with greater control during complicated procedures and, we believe, has a positive impact on patient outcomes. 

Our Senior Clinical Research Associate will have responsibility for developing and implementing the strategy for clinical studies of our new vascular Magellan robot, which is the first such system specifically, designed for peripheral endovascular interventions. In this highly visible and interactive position, the CRA must have excellent analytical, and communication skills as well as anatomy and medical knowledge.  Demonstrated experience in the initiation and administration of clinical trials a must. The position is responsible for development of research protocols for multiple centers and travel both nationally and internationally to monitor and coordinate the clinical studies. The position will interact with a global Marketing, Sales, Engineering and Training teams to execute a successful research agenda for the Hansen products.

Essential Functions:

  • Collaborates with interventional physicians to create and implement investigator initiated clinical studies that match the business objectives of the company.
  • Participates in interdepartmental product teams to validate and represent clinical research agenda. Members include R&D, Clinical Engineering, Marketing and Corporate Training. 
  • Drafts, initiates and monitors clinical research protocols for timely success in interventional cardiology and vascular medicine.
  • Performs all duties of clinical study administration – protocol maintenance, budgeting, informed consent origination, investigator brochure origination, data collection methods and analysis, routine report generation for investigator meetings, evidence based medicine committee and the FDA.
  • Works on problems of diverse clinical and research scope where analysis of data is pivotal to bias control and clinical trial success.
  • Problem solves with department colleagues, physician investigators, clinical study committees and core labs to achieve study success and accurate study reporting.
  • Supports Marketing, Training and Sales departments in developing clinical education materials.
  • Works independently on daily work goals; receives general instructions on new assignments.
  • Ability to travel up to 50% in the first 6 months, both domestic and international; then reduced to 25% per project management

Requirements:

  • Requires BS; Master’s degree a plus
  • RN preferred
  • Minimum 5 years of related experience at a senior level in the medical device industry managing clinical research protocols

Hansen Medical, Inc. is an Equal Opportunity Employer

Please apply using the following link: 
https://home2.eease.adp.com/recruit/?id=10334902

Clinical Research Associate

Summary:

Hansen Medical is a global leader in flexible medical robotics.  Our innovative technology provides physicians with greater control during complicated procedures and, we believe, has a positive impact on patient outcomes.

Our Clinical Research Associate will have responsibility for developing and implementing the strategy for clinical studies of our new vascular Magellan robot, which is the first such system specifically, designed for peripheral endovascular interventions. In this highly visible and interactive position, the CRA must have excellent analytical, and communication skills as well as anatomy and medical knowledge.  Demonstrated experience in the initiation and administration of clinical trials a must. The position is responsible for development of research protocols for multiple centers and travel both nationally and internationally to monitor and coordinate the clinical studies. The position will interact with a global Marketing, Sales, Engineering and Training teams to execute a successful research agenda for the Hansen products.

Essential Functions:

  • Collaborates with interventional physicians to create and implement investigator initiated clinical studies that match the business objectives of the company.
  • Participates in interdepartmental product teams to validate and represent clinical research agenda.  Members include R&D, Clinical Engineering, Marketing and Corporate Training. 
  • Drafts, initiates and monitors clinical research protocols for timely success in interventional cardiology and vascular medicine.
  • Performs all duties of clinical study administration – protocol maintenance, budgeting, informed consent origination, investigator brochure origination, data collection methods and analysis, routine report generation for investigator meetings, evidence based medicine committee and the FDA.
  • Works on problems of diverse clinical and research scope where analysis of data is pivotal to bias control and clinical trial success.
  • Problem solves with department colleagues, physician investigators, clinical study committees and core labs to achieve study success and accurate study reporting.
  • Supports Marketing, Training and Sales departments in developing clinical education materials.
  • Supports Clinical Engineering. 
  • Assisting with pre-clinical laboratory work, as needed
  • Works independently on daily work goals; receives general instructions on new assignments.
  • Ability to travel up to 50% in the first 6 months, both domestic and international; then reduced to 25% per project management

Requirements:

  • Requires BS or equivalent experience; Master’s degree a plus
  • RN preferred
  • Minimum 5 years of related experience in the medical device industry managing clinical research protocols
  • Strong verbal and written communication skills
  • Strong interpersonal skills with the ability to quickly develop relationships
  • Prior work in start-ups, with extensive clinical ops experience
  • Self-motivated & success oriented
  • Extremely well organized
  • Strong work-ethic & flexible
  • Adept at technical writing, including clinical reports, adverse event reports, protocol and informed consent, regulatory submissions, and prep of CRFs
  • Ability to work with MS Office including Word, Excel, PowerPoint

Hansen Medical, Inc. is an Equal Opportunity Employer

Please apply using the following link: 
https://home2.eease.adp.com/recruit/?id=11448412

Senior Clinical Engineer

Summary:

Hansen Medical is looking for a highly technical and creative engineer to join the Clinical Engineering team. Working closely with R&D, our Sr. Clinical Engineer brings a unique perspective and skill set to the design and development of new products. Our Sr. Clinical Engineer will be involved in the evaluation of existing technology and methodologies and advise on new processes, developing new concepts from initial design to commercialization. We are looking for a highly technical and creative engineer to join our team.

Essential Functions:

  • Coordinates system-level evaluation of complex catheter, mechanical, controls, and software featured products
  • Active member of R&D teams throughout the design process, conducting clinically-oriented evaluation as necessary in the concept, iteration, design freeze, and validation phases
  • Voices and defends customer requirements in R&D teams, authoring top-level requirements documentation
  • Conducts design validation studies for new and modified medical devices, including authoring plans, protocols, data forms, and reports
  • Serves as a clinically oriented evaluator of new devices designs, screening ideas prior to customer-facing studies
  • Performs and documents user-based risk analysis
  • Networks with senior internal and external personnel in own areas of expertise
  • Supports feasibility clinical trials and product roll-out clinical evaluation (PPT) domestically and internationally
  • Trains physicians and Hansen Medical clinical support personnel in new products
  • Drafts clinical engineering portions of regulatory filings
  • Authors content for device instructions for use
  • Manages all phases of GLP acute and survival studies as required by the product development and regulatory process

Requirements:

  • Bachelor’s degree or equivalent experience; Master’s degree preferred
  • Minimum 5 years of experience in medical device engineering; cardiovascular experience a plus
  • Experience in a pre-clinical setting
  • Knowledge of basic anatomy, surgery terminology, and cardiovascular procedures
  • Experience in conducting design validation studies and gathering physician feedback on medical devices
  • Experience in the regulated medical device environment, including but not limited to document control processes, document approval processes, study archiving, data collection, and phase/design reviews
  • Ability to travel up to 30% of the time, internationally and domestic

Hansen Medical, Inc. is an Equal Opportunity Employer

Please apply using the following link: 
https://home2.eease.adp.com/recruit/?id=8390672

Senior Manufacturing Engineer

Summary:

Provides technical and sustaining engineering support in a manufacturing area. Recommends and implements equipment, tool and process modifications to improve production efficiencies, manufacturing techniques and production yields for existing products. Develops and conducts statistical analysis targeting physical cause of failure for yield loss and improving quality. Interacts with product design and development personnel to ensure that processes and designs are compatible. 

Essential Functions:

  • Resolves a wide variety of issues in creative ways.
  • Design and develop tooling, equipment, and fixtures for the manufacture of new and existing products.
  • Support prototype and pilot production of new products, product changes, and improvements
  • Procure and oversee outside vendors and consultants as required. Interface with vendors and other outside specialists
  • Develop and implement validation protocols for new manufacturing equipment and processes.
  • Provide guidance to project teams for attaining DFM and developing manufacturing strategies to attain volume, cost, and quality goals.
  • Support process optimization and yield improvement goals.
  • Support continuous improvement of existing production processes and operations. Identify and implement improvement activities to increase/optimize yield, efficiency or throughput.
  • Create and maintain production documentation.  Train production personnel as required.

Requirements:

  • BS in Mechanical Engineering or a related technical field. 
  • Proficiency with SolidWorks is required.
  • Minimum of 5 years of manufacturing engineering experience and at least 2 years working in the Medical Device Industry.  . 
  • Must have strong communication skills and ability to work independently on a day to day basis.

Hansen Medical, Inc. is an Equal Opportunity Employer

Please apply using the following link: 
https://home2.eease.adp.com/recruit/?id=11036622

Senior Verification Engineer

Summary:

Working in a multi-disciplinary environment with software, control, electrical and mechanical engineers, our Software/System Senior Verification Engineer will lead the test planning, definition, execution, and monitoring activities for complex electro-mechanical medical device products.

Essential Functions:

Responsible for creating, executing and monitoring System Verification test protocols.  This includes defining tests based on engineering requirements, reporting and tracking System Verification test results and maintaining verification trace matrices.

  • Responsible for execution of verification tests according to written test procedures
  • Document and verify software defects found during testing
  • Responsible for documenting test reports capturing results of test execution
  • Participates in the creation and maintenance of System Requirements using product technical knowledge
  • Design test design specification and test cases in protocols ensuring adequate testing coverage and efficient test execution
  • Participates in product design documentation reviews for safety, consistency, traceability and compliance to regulations
  • Work with development teams to review and improve requirements, specifications and test plans
  • Mentors other verification team members
  • Coordinates with the Test Engineers on Verification test activity
  • Participates in other top-level project activities such as DHF/DHR, RTM, etc.

This position is for someone with a desire to work in a multi-disciplinary environment in a highly visible position.  The right person will have the opportunity to make a significant contribution to our products.

Requirements:

  • Must have excellent written and verbal communication skills
  • Experience in developing System Requirements and System Verification tests for medical device industry (21 CFR Part 820.30) or other regulated industries is highly desirable
  • Knowledge of industry risk standards such as ISO 14971 or software standards such as ISO 62304 is highly desirable
  • Experience with creation and maintenance of System/Software Verification plans and associated trace matrices is desirable
  • B.S. degree (with 5 years experience) or M.S. degree (with 3 years experience) in Engineering, Computer Science or other related technical discipline or equivalent combination of education and experience
  • Experience with automated testing is desirable
  • Experience testing electro-mechanical devices is desirable
  • Ability to lead small test development teams is desirable
  • Must have a passion for testing

Hansen Medical, Inc. is an Equal Opportunity Employer

Please apply using the following link: 
https://home2.eease.adp.com/recruit/?id=11245302

R&D Engineering Intern – Robotic Catheter Group

Summary:

The R&D Catheter Engineer Intern will work in the catheter R&D team of this robotic medical device company. This role will have the opportunity to learn the steps involved in the product development process, from concept phase, through prototyping, testing, validation and transfer to manufacturing.

Essential Functions:

  • Work with R&D engineers to optimize the design of steering systems, composite braided catheter shafts, and mechanical interface of disposable medical devices
  • Conduct evaluation and/or mathematical modeling of some parts of the design to help optimize the design iteration process and improve design manufacturability
  • Carry out and thoroughly report on laboratory and system level testing, including statistical data analysis in relation to design specifications and test objectives
  • Prepare, characterize and test catheter / mechanical prototypes for animal labs and design verification
  • Design, build and document mechanical test fixtures
  • Carry out tolerance analysis on designs as appropriate
  • Interact with vendors to obtain engineering materials, processes and equipment

Requirements:

  • Engineering degree or actively pursuing Engineering degree in mechanical engineering or similar with completion of at least 1 year of upper-division undergraduate course work; Master’s degree preferred
  • Strong computer skills (SolidWorks, word processing, and spreadsheets required)
  • Experience working in machine shop environment preferred
  • Problem solving skills
  • Detail oriented with an emphasis on data gathering and analysis
  • Strong interpersonal skills
  • Excellent oral and written communication skills
  • Excellent time management skills, comfortable working on multiple projects at once

Hansen Medical, Inc. is an Equal Opportunity Employer

Please apply using the following link: 
https://home2.eease.adp.com/recruit/?id=11036262

Sensing Technology/Software Engineering Intern

Summary:

The Sensing Technology/Software Engineering Intern will be working with a novel sensing technology that will be integrated into robotically steerable catheters. 

Essential Functions:

  • Sensor analysis, design, and testing activities at the system level as well as at the component level
  • Implementation of software that monitors and tests the sensor system, including user interface and 3D graphics
  • Analysis of sensor data in Matlab

Requirements:

  • Hands on experience with electromagnetic, computer vision, or fiber optic based position sensing technology
  • A strong working knowledge of C++
  • Experience with building user interfaces and using 3D computer graphics and 3D transformations
  • Experience with Matlab
  • Experience with Microsoft Windows OpenGL development a plus
  • Strong communications and people skills
  • Computer Science or Electrical Engineering major (or related field) with completion of at least one year of upper-division undergraduate course work.  Graduate student preferred.

Hansen Medical, Inc. is an Equal Opportunity Employer

Please apply using the following link: 
https://home2.eease.adp.com/recruit/?id=11245312

 

Hansen Medical is a fast-paced rapidly growing medical robotics company with a seasoned executive team and talented, inspired employees. We currently develop and market products for clinical applications in electrophysiology and peripheral vascular disease. Our Magellan™ Robotic System, developed in partnership with Philips Medical Systems, represents a new robotic approach designed to enable physicians to remotely and precisely manipulate robotically steerable catheters and standard guidewires using advanced controls and visualization.

Our Sensei® X system is designed to allow physicians three-dimensional catheter control during complex procedures within the chambers of the heart. Hansen Medical technology enhances the physician's ability to access hard to reach anatomy, repeat procedure steps, and maintain catheter stability during procedures.

We are currently hiring passionate, creative people for the positions listed below. If you are seeking a stimulating and dynamic environment where your contributions will be visible, please forward your cover letter and resume or curriculum vitae to recruiting@hansenmedical.com. At Hansen Medical we embrace the uninhibited imagination and innovative engineering it takes to provide real solutions to everyday clinical problems.

If you are a job seeker with a disability and require accessibility assistance or an accommodation to complete any part of the application process, or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact 650-404-2718 or accessibility@hansenmedical.com for assistance.

Hansen Medical, Inc. is an Equal Opportunity Employer.

LT0050 Rev A_002