UNITED STATES | INTERNATIONAL | CAREERS

BENEFITS

TriVascular offers competitive salaries and an excellent benefits package that includes:

  • Medical, Dental, Vision Insurance
  • Health Care and Dependent Daycare
  • Reimbursement Account
  • 401(k) Retirement Savings Plan
  • Stock Options
  • Basic Life Insurance
  • Long-Term Disability Benefits
  • Paid Time Off
  • Paid Holidays
  • Tuition Reimbursement

Thinking of relocating to Sonoma Co.?
Need answers to all the who, what, where, when, and how questions?
Click here to connect on Sonoma County Connections!

Careers

Our commitment to patients and their families is a major driving force behind what we do here at TriVascular. We believe this motivation, together with innovation and dedication, will allow us to bring breakthrough treatments to patients, while expanding endovascular care worldwide. Employees continue to cite the chance to make a difference in the lives of patients as the number one reason they enjoy working at Trivascular.
 

“Thank you for your interest in exploring a potential career with TriVascular Inc. Our central purpose is to help physicians improve the lives of patients suffering from aortic disease through excellence in research, manufacturing and service. We are committed to acquiring a deep understanding of our customer’s needs and to developing innovative, clinically compelling products. We meet customer needs by working diligently, carefully listening, and genuinely caring.

We strongly believe that how you do things matters as much as what you do. Our corporate culture is centered on teamwork, accountability, and service. We are committed to cultivating a high-performance organization in which integrity; excellence, innovation, quality and leadership are the norm. These values are the framework for conducting our business and we use them to guide all our decisions and actions. We recognize that patients rely on us to provide superior products and services, and we must continuously pursue excellence in all aspects of our business.

TriVascular Inc. is an entrepreneurial company deeply committed to creating a work environment where excellence can live and grow. Our compensation and benefits package is designed to reward individual and company performance, as our success depends on each of us doing our very best both individually and as part of our team.

Our employees are here because they believe in our mission and want their voices and actions to be heard and matter. We believe each employee has a tremendous ability to grow and contribute. We are looking for special individuals who are passionate about life and inspired by our purpose. If you find great meaning in what we do, have values that align with ours, and are a high achiever committed to making a difference; then I encourage you to pursue a career at TriVascular. ” 

— Christopher Chavez, CEO.


JOB OPENINGS

Regulatory Affairs Specialist/Sr. Regulatory Affairs Specialist - Santa Rosa

Job Description

The Regulatory Affairs Specialist / Sr. Regulatory Affairs Specialist is responsible for product, submission, and base business maintenance support in order to meet organization goals and objectives. 

OVERALL RESPONSIBILITIES

  • Prepare, evaluate and present regulatory strategies and plans for worldwide markets. Provide strategy leadership, support and feedback to product development teams.
  • Prepare original 510(k), IDE, PMA, technical files, design dossiers and subsequent amendments/supplements as required to ensure timely approval for clinical studies and market release.
  • Review, evaluate and discuss complex regulatory issues with management and team, when required, and negotiate these issues with regulatory agency personnel.
  • Provide post-commercialization support, including: review and advice on labeling, product claims, or marketing programs to ensure compliance with regulations; review and submission of device/ quality system changes as required by worldwide regulations; and worldwide compliance support.
  • Conduct presentations to and negotiate directly with worldwide regulatory agency reviewers and/or inspectors as needed. 
  • Interpret existing or new regulatory requirements and maintain proficiency in these requirements as they relate to company products and procedures, clinical studies, testing, or recordkeeping.
  • Maintain information in various compliance databases and product files and produce reports as needed to support compliance with regulatory requirements.
  • Provide training and support to other members of the department and the organization, as necessary.

QUALIFICATIONS
  • Regulatory Affairs Specialist: Bachelor’s degree or equivalent work experience and 2+ years medical device regulatory experience is highly preferred, including successful submissions and strategies.
  • Sr. Regulatory Affairs Specialist: Bachelor’s degree or equivalent work experience and 5+ years medical device regulatory experience is highly preferred, including successful submissions and strategies.
  • FDA, MDD and other international regulations pertaining to the design, manufacture and commercialization of medical devices. Experience in creating and submitting domestic and international regulatory submissions and changes to existing products in compliance with U.S. and OUS regulations and procedures required for submission of applications.
  • Ability to multi-task and work effectively in a fast-paced environment.
  • Work independently and within a team-oriented organization.
  • Organize and problem solve effectively.
  • Effectively communicate and negotiate, both orally and in writing.
  • Take initiative to meet deadlines through effective project management and to work with minimal supervision.
  • Compile and process regulatory submissions using the current regulatory agency requirements.
  • Manage a multi-task job and appropriately adjust priorities.
  • Interpret and apply policies and procedures appropriately.
  • Knowledge of computer programs (Word, Excel, PowerPoint, Database Management)


Sr. Mfg / Process Development Engineer - 3 Month Temp Position - Santa Rosa

Job Description

Manufacturing and Process Development Engineers within TriVascular are passionate about driving excellence in the manufacturing of quality Medical Devices. They are dynamic in nature and relentless at discovering opportunities to improve the systems around them. They are intimate with the cutting edge process technologies and are responsible for implementing process improvements while supporting the introduction of new products to the market. ‘Can’t be done’ is not in their vocabulary and ‘what’s next’ is their doctrine. They understand the importance of high quality standards and know how to achieve them. They seek out waste and eliminate it. They enjoy their position and continuously grow as a valuable team member and leader of change.

OVERALL RESPONSIBILTIES

  • Supports manufacturing personnel and creates systems to aid in the production of multiple medical device families
  • Support new product development through engagement with the R&D group and guides Design For Manufacturing activities in the early phases of projects
  • Drives appropriate resolutions to manufacturing issues ensuring excellence in quality, cost and delivery
  • Leads projects and engages with multiple teams members across all functional groups within TriVascular
  • Identifies operational waste and institutionalizes systems to improve TriVascular Core Operational Metrics – Throughput, Yield, Output, Productivity and Compliance
  • Accurately applies statistics and sound logical thinking to evaluate and understand manufacturing processes and makes robust recommendations for improvements
  • Communicates changes effectively to team members and capable of planning and executing those changes
  • Is driven by data. Listens to the voice of the process and voice of the customer when assessing manufacturing system improvements.
  • Coordinates the work of assigned technicians and engineers and takes responsibility for their results.
  • Maintains accurate manufacturing documentation
  • Continues to develop their knowledge of the medical device industry and keep up to date with manufacturing technologies
  • Aligns systems throughout the product Value Stream to create value for all customers 
  • Focus on long term success by standardizing processes, eliminating variation and seeks perfection
  • Provide technical support for root cause analysis, identifies corrective actions and implement effective controls 
  • Adheres to all TriVascular policies and procedures by being up to date with all TriVascular training requirements
  • Well versed in the implementation of Lean Principles and Six Sigma methodologies
  • Creates risk assessments and implements controls to mitigate risks as they are identified 

QUALIFICATIONS

  • B.S. Degree in Engineering with 5+ years’ experience, or an M.S. with 3+ years’ experience 
  • Experience leading Process Validation efforts with new product process development in an FDA regulated manufacturing environment is highly desired. Experience in medical device field is extremely beneficial.
  • Understanding of Nitinol, PTFE, or Catheter based Delivery Systems is preferred.
  • The ability to successfully lead cross functional teams and understands the importance of team work.
  • Fully engaged in the use of continuous improvement tools such as Visual management Systems, A3’s, DFMA and 6-Sigma.
  • Excellent analytical abilities and experienced with the use of Statistics to solve problems.
  • Thorough understanding of SPC and the ability to use this information to eliminate variation.
  • An individual who takes pride in their workmanship, relies on facts and data, and has constancy of purpose in their actions.
  • Has initiative to meet or adjust deadlines and works effectively within a team environment.

PREFERRED KNOWLEDGE

  • Experienced user of Statistical Process Control (SPC)
  • Has created and interpreted research through the use Design of Experiments
  • Performed Process Validation by creating and executing protocols, reports, testing and reviews
  • In-Depth knowledge of 21 CFR Part 820 and regulatory requirements for Medical Devices
  • ISO 13485:2003, Medical Devices and ISO 14971:2007, Medical Devices
  • Worked with Quality Management Systems
  • Application of Risk Management as it pertains to Medical Devices
  • Implemented Design for Manufacturing/Assembly within new product development

Principal Regulatory Affairs Specialist - Santa Rosa

Job Description

The Principal Regulatory Affairs Specialist is responsible for leadership of product, submission, and base business maintenance in order to meet organization goals and objectives. Exercise a leadership role and serve as a mentor to help develop regulatory depth and knowledge within the regulatory department staff.

OVERALL RESPONSIBILITIES

  • Prepare, evaluate and present regulatory strategies and plans for worldwide markets, with an emphasis on geographies outside the U.S. Provide strategy leadership, support and feedback to product development teams.
  • Prepare high-quality and well-organized original 510(k), IDE, PMA, technical files, design dossiers, other product submissions as required, and subsequent amendments/supplements to ensure timely approval for clinical studies and market release.
  • Review, evaluate and discuss complex regulatory issues with management and team, when required, and negotiate these issues with regulatory agency personnel.
  • Provide post-commercialization support, including: review and advice on labeling, product claims, or marketing programs to ensure compliance with regulations; review and submission of device/ quality system changes as required by worldwide regulations; and worldwide compliance support.
  • Conduct presentations to and negotiate directly with worldwide regulatory agency reviewers and/or inspectors as needed. 
  • Interpret existing or new regulatory requirements and maintain proficiency in these requirements as they relate to company products and procedures, clinical studies, testing, or recordkeeping.
  • Provide training and support to other members of the department and the organization, as necessary.
  • Complete other assigned tasks as required.

QUALIFICATIONS

  • Bachelor’s degree or equivalent work experience and 10+ years medical device regulatory experience is highly preferred, including successful submissions and strategies.
  • FDA, MDD and other international regulations pertaining to the design, manufacture and commercialization of medical devices. Experience in creating and submitting domestic and/or international regulatory submissions and changes to existing products in compliance with U.S. and OUS regulations and procedures required for submission of applications.
  • Ability to multi-task and work effectively in a fast-paced environment.
  • Work independently without appreciable supervision and within a team-oriented organization demonstrating excellent interpersonal skills.
  • Organize and problem solve effectively.
  • Effectively communicate and negotiate, both orally and in writing.
  • Take initiative to meet deadlines through effective project management and to work with minimal supervision.
  • Compile and process regulatory submissions using the current regulatory agency requirements.
  • Manage a multi-task job and appropriately adjust priorities.
  • Interpret and apply policies and procedures appropriately.
  • Provide guidance to lower level personnel.
  • Knowledge of computer programs (Word, Excel, PowerPoint, Database Management)

Territory Manager - Multiple locations across US

Job Description

The Territory Manager (TM) for TriVascular Sales LLC (a subsidiary of TriVascular, Inc.) will be responsible for promoting, selling and supporting the company’s EVAR solutions within an assigned territory in order to meet customer (patient and physician) and TriVascular objectives. This position may require working weekends and extensive overnight travel (up to 60-80%), depending on territory specifics. 

POSITION RESPONSIBILITIES
  • Prepare and continuously update territory sales plan and business database.
  • Utilize an ethical, consultative sales approach to drive physician and hospital usage of and commitment to the Company’s products. 
  • Meet quarterly and annual sales targets as established by the Company.
  • Possess and share superior clinical knowledge of the Company’s products, their clinical applications, instructions for use, and procedural techniques.
  • Provide technical and educational training to physicians and staff on the use of the company’s products.
  • Provide ongoing case support, including Operating Room/ procedure support.
  • Prepare case plans and identify recommended devices based on preoperative imaging studies (CT/Angiography) to support physician planning and treatment of patients.Develop and maintain relationships with physicians and staff in assigned accounts by providing a high level of service and responsiveness and by providing ongoing education and clinical expertise regarding the use of company’s products.Collect and report competitive information to Marketing. 
  • Prepare reports including weekly call reports, weekly expense reports, and other reports as assigned. Participate in customer meetings, training meetings (internal and external) conferences and/or other relevant meetings.
  • Support company goals, objectives, policies and procedures, including policies regarding customer entertainment and customer relations. 
  • Follow FDA and other applicable regulations.
  • Take on additional responsibilities outside of the scope of this list as business needs and managerial direction dictate.
QUALIFICATIONS 
  • BS/BA degree, preferably in Life Sciences, Business, Nursing, or other technical discipline or equivalent work experience.
  • Ten or more years of successful sales and/or clinical experience, including experience in the Operating Room and/or Interventional Suites, or at least five years of sales and/or clinical experience within the vascular field. 
  • Prior EVAR success a significant plus.
PREFERRED KNOWLEDGE
  • Excellent interpersonal and communication (verbal and written) skills, with the ability to effectively interact with stakeholders across a customer site (physicians, staff, purchasing, administration, etc.).
  • Strong initiative and positive attitude, with strong problem solving/decision making skills.Strong ethics, teamwork, and a customer-centric attitude.Knowledge and ability to produce and utilize documents in Microsoft Word, Excel, PowerPoint, internet access and web-based navigation skills.Ability and willingness to travel and work long hours including weekends to meet business objectives and satisfy patient and physician needs.
  • Possesses an entrepreneurial spirit and a strong preference for a performance based compensation system.Freedom to work in the EVAR field within a given territory/geography.

Clinical Specialist - Western U.S.

Job Description

The Clinical Specialist (CS) for TriVascular Sales LLC (a subsidiary of TriVascular, Inc.) will support the TriVascular sales team within a specified geography (region/country) by providing customer service, technical assistance, case planning and case support services to (primarily) established customers. The CS position may require extensive overnight travel of up to 60-80%, frequently on short notice, depending on geography specifics. Should reside in a high (patient) population-density area and/or have access to a major airport.

POSITION RESPONSIBILITIES
  • Possess and share superior clinical knowledge of the Company’s products, their clinical applications, instructions for use, and procedural techniques.
  • Provide technical and educational training to physicians and staff on the use of the company’s products. 
  • Provide case support, including Operating Room/procedure support.
  • Prepare case plans and identify recommended devices based on preoperative imaging studies (CT/Angiography) to support physician planning and treatment of patients.Utilize an ethical, consultative approach to support physician and hospital usage of and commitment to the Company’s products. 
  • Assist in assigned market development projects as assigned by manager.
  • Develop and maintain relationships with physicians and staff in assigned accounts by providing a high level of service and responsiveness and by providing ongoing education and clinical expertise regarding the use of company’s products.
  • Collect and report competitive information to Marketing. 
  • Prepare reports including weekly call reports, weekly expense reports, and other reports as assigned.
  • Participate in customer meetings, training meetings (internal and external) conferences and/or other relevant meetings.
  • Support company goals, objectives, policies and procedures, including policies regarding customer entertainment and customer relations. 
  • Follow FDA and other applicable regulations.
  • Take on additional responsibilities outside of the scope of this list as business needs and managerial direction dictate. 
  • Assignments may include market development activity.
QUALIFICATIONS
  • Prior industry (clinical specialist/sales) experience.
  • Five or more years of clinical (hospital and/or industry) experience in the Operating Room and/or Interventional Suites, with at least two years of vascular experience. 
  • Prior EVAR experience (nurse/tech and/or industry) strongly preferred.
  • Four year degree and/or relevant allied health professional status required. 
PREFERRED KNOWLEDGE
  • Excellent interpersonal and communication (verbal and written) skills, with the ability to effectively interact with stakeholders across a customer site (physicians, staff, etc.).
  • Strong initiative and positive attitude, with good problem solving and decision making skills.
  • Strong ethics, teamwork, and a customer-centric attitude.Knowledge and ability to utilize Microsoft Word, Excel, PowerPoint, internet access and web-based navigation.
  • Ability and willingness to travel and work long hours including weekends to meet business objectives and satisfy patient and physician needs.
  • Freedom to work in the EVAR field within a given area/geography.
Click here to apply for the CLINICAL SPECIALIST position
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.