TriVascular, Inc. is a rapidly growing medical device company developing innovative products for the treatment of cardiovascular disease.

Located in Santa Rosa, CA, TriVascular is committed to developing new devices that address unmet clinical needs while providing an excellent working environment for its employees.

TriVascular offers competitive salaries and has an excellent benefits package, including medial care, dental and vision plans, life insurance, and a 401(k) Plan. See below for the full array of benefits offered by TriVascular.

Send Resumes To: HR@TriVascular.com

Clinical Field Specialist

The Clinical Field Specialist (CFS) will be responsible for providing technical, educational, and clinical study support to assist in meeting clinical study and investigator training objectives. The CFS will monitor the investigational use of the medical device in accordance with instructions for use, operational technique and study protocol. The CFS provides ongoing clinical site support as needed throughout all phases of the clinical study. The position often requires working with clinical sites to ensure compliance with study protocols, device instruction/training for use, FDA regulations, IRB requirements and overall clinical objectives. The position will require 60-80% estimated per annum of travel.

BS/BA Degree or equivalent work experience in Life Sciences, Medicine, Nursing or other technical discipline. 2-4 years of experience with case support in Thoracic and/or Abdominal Endovascular procedures is required. Prior experience in interventional cardiology, cath lab, or endovascular OR environment as a nurse or technician is preferred. Experience and knowledge of the use of investigational devices in clinical studies, in accordance with FDA regulations and Good Clinical Practices is also preferred.

Document Services Specialist

The Document Control Specialist is primarily responsible for executing the company’s document controls, including item number assignment, document change order processing and master document archival. Will also be responsible for controlled document distribution and revision tracking along with supporting the quality records functions of the Document Services Department.

Overall Responsibilities Include:

• Perform the day-to-day operations of the document control system - creation, change control, distribution, archival, and obsolescence of master and controlled copy documentation, in soft and hard copy formats.
• Perform operations in the systems which partner with the document control system (e.g., MES, ERP).
• Monitor key Document Services metrics and prepare reports as needed by management.
• Assist in the development of, and enforce document control and quality record requirements in order for the company to meet internal and external needs.
• Provide instruction (including classroom training) to employees, as needed, to promote compliance with the various requirements of Document Services.
• Serve as backup to the Document Control Clerk, issuing and archiving engineering builds and laboratory notebooks, checking in, scanning, filing and checking out lot history records.
• Will also work with SOP and manufacturing training records and maintaining the external document library.

AA or BA degree or equivalent experience working in the medical device industry is desired. This position will require 3-5 years of hands-on experience in a Document Control function working with medical device regulations, electronic PDM/PLM systems and ERP. Experience with configuration management, MS Word, Excel and Visio is also desired. Ability to read and understand mechanical (CAD) drawings is also a plus.

Process Validation Engineer (Contract Position 2-3 months)

This individual will apply intensive and diversified knowledge of test method validation principles, practices and implementation in complex systems and assignments. General responsibilities include validation test design generation and testing to assess performance against specifications; repeatability testing, and assessment of system sources of variation. This individual will make independent decisions and assist in the troubleshooting of issues to determine root cause and possible engineering solutions.

Overall responsibilities include:

• Perform test method validation activities for manufacturing verification processes.
• Complete accurate and timely documentation including plans, protocols, reports, etc.
• Work with Product Development staff to ensure that verification test methods under development are validated.
• Prepare and administer change orders for validation associated documentation.
• Work in compliance with US and international quality systems requirements.
• Present project status, issues and concerns to senior management.

BS or equivalent in a directly related discipline. Advanced degree highly preferred.

At least 2 – 5 years of experience in a medical device related field and/or manufacturing environment is needed.

Demonstrates success in technical proficiency, creativity, collaboration with others and independent thought. Strong writing skills are necessary. Expert knowledge and application of process and test method validation principles and concepts. Take initiative to meet deadlines and work with limited supervision. Interpret and apply policies, regulatory standards and procedures appropriately.

This position will also require experience with Quality systems documentation continuous improvement and PC operations. Should also have experience Microsoft Word/Excel.

Note to Agencies and Recruiters:
Resumes received by TriVascular from search firms and/or individual recruiters are considered unsolicited, unless a contractual obligation otherwise exists  between TriVascular and the entity from which the resume is received.