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

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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. 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.

TriVascular 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.


"All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or on the basis of disability."


JOB OPENINGS

Sr. Recruitment Specialist - Santa Rosa

Job Description

The Sr. Recruitment Specialist will work with a passion to attract and retain high quality candidates as part of a multi-discipline HR team.  Our goal is to ensure an outstanding client focus and support through the effective administration of TriVascular’s programs, policies and procedures.  S/he will specialize in Talent Acquisition and Recruiting while acting as a steward of the organizational culture and values, contributing to other HR initiatives as needed in areas such as: talent management, performance management, organizational development, compliance and reporting.   As the lead for the talent acquisition process, s/he will develop and execute recruitment plans and hiring strategies for current and future staffing needs.    

Here is How You Would Support TriVascular, Our Staff and Our Clients:


  • Work closely with hiring managers and Human Resource Director, in the planning  of recruitment strategies and in the delivery of qualified candidates for all hiring needs
  • Work closely with outside recruitment agencies as necessary, coordinating the recruitment efforts for staff and contractors
  • Network, build and maintain relationships, promote the company, create a talent pipeline of candidates  
  • Serve as a resource and support to employees, HR staff and management in HR sponsored programs and initiatives

 You’re our Ideal Candidate if You Have:

  • Bachelor’s degree and minimum 3-5 years in a recruitment or generalist role with a strong focus on recruitment for all levels of the organization from entry level non-exempt positions to senior leadership positions

  • Must have knowledge of full life cycle recruiting, applicant tracking systems and use of Social Media 

  • Knowledge of various functions (manufacturing, quality, sales, marketing, engineering, information systems, etc.) within an organization and the challenges of supporting and filling positions within a regulated environment 

  • Strong communicator with the ability to influence and persuade across all levels of the organization, exercising a high degree of confidentiality, professionalism, poise, tact and diplomacy to accomplish objectives 

  • Strong interpersonal skills with the ability to clearly present recommendations and ideas and to summarize complex issues 

  • Ability to work under pressure in a fast-paced, time-sensitive environment with shifting priorities and multiple deadlines, ability to shift focus from one HR functional area to another as necessary 

  • Previous experience in human resources within medical device or engineering industries


Manufacturing / Process Development Engineer - Santa Rosa

Job Description

We are seeking a MEPD Engineer that develops, evaluates, and improves manufacturing methods, utilizing knowledge of product design, materials and parts, fabrication processes, tooling and production equipment capabilities, assembly methods, and quality control standards. Accesses process capabilities, prioritizes process improvement opportunities and innovates and implements process improvements. 


OVERALL RESPONSIBILITIES

  • Designs develops, monitors, and improves manufacturing processes and equipment for new products, product changes and enhancements
  • Support manufacturing lines by providing technical expertise to resolve assembly, product quality and documentation issues
  • Evaluate and understand the manufacturing process parameters that affect product quality, yields, through-put, and productivity. Make recommendations, plans, and implement activities that continuously improve these parameters
  • Applies statistical methods to estimate future manufacturing requirements and potential
  • Coordinate work of assigned technicians 
  • Plan and schedule projects in a manner consistent with corporate objectives
  • Contribute to the intellectual property position of the company via invention and patent applications
  • Maintain accurate documentation of concepts, designs, processes, and equipment
  • Maintain current knowledge of medical, technical, and biomedical developments as related to company products
  • Support prototype and pilot production of new products, product changes, and enhancements in coordination with the Manufacturing and Quality Control functions  
  • Work with product development staff to ensure that products under development are optimally manufacturable and to resolve manufacturing issues
  • Procure and oversee outside vendors and consultants as required  
  • Complete accurate and timely manufacturing documentation including manufacturing procedures, materials records, etc
  • Adhere to safety rules, company policies and procedures.  Actively promotes a safe work environment
  • Responsible for 100% adherence to the principals of the site Quality Policy 
  • Remains up-to-date with training requirements at all times

PREFERRED KNOWLEDGE & ABILITIES

  • Experience with statistical process control (SPC) and Design of experiments
  • 21 CFR Part 820
  • ISO 13485:2003, Medical Devices and ISO 14971:2012, Medical Devices
  • Quality Management Systems
  • Requirements for Regulatory Purposes
  • Application of Risk Management to Medical Devices
  • Appropriate knowledge and experience with risk management techniques or with similar device technologies, experience by possession of relevant technical degrees or experience with the subject device through either design or process development experience
  • Lean Manufacturing experience and knowledge.  Able to identify and eliminate waste consistent with Lean principles
  • Understanding of Six Sigma problem solving methodology
  • Lead others in critical thinking, problem solving and analysis and effective technical project leadership
  • Team leadership and strong technical skills
  • Excellent communication, both orally and in writing
  • Manage a multi-task job and appropriately adjust priorities.
  • Interpret and apply policies and procedures appropriately
  • Experience with nitinol, PTFE, or catheters is preferred 

QUALIFICATIONS

  • Experience leading new product process development and process validation efforts in an FDA or other manufacturing environment highly desired
  • A.A /BA degree or equivalent work experience in an engineering/technical position
  • 3 to 5 years of medical device experience is highly preferred

Click here to apply for the MANUFACTURING / PROCESS DEVELOPMENT ENGINEER position



Quality Engineer - Santa Rosa

Job Description

The Quality Engineer collaborates with R&D and Process Engineering groups to develop, monitor, and maintain a comprehensive quality inspection program for the manufacture of medical devices.  Works with Operations to promote good documentation practices and continuous improvement.  Help expedite the timely identification, root cause determination and corrective actions for quality system issues. 

OVERALL RESPONSIBILITIES

  • Identifies and implements effective process control systems to support the development, qualifications, and on-going manufacturing of products to meet or exceed internal and external requirements
  • Reviews production quality records and documentation, monitors quality metrics, and prepares risk assessments; audits compliance of quality records
  • Applies root cause analysis techniques during the investigation of non-conformances. Leads in the implementation of appropriate corrective and preventive actions resulting from non-conformances 
  • Participates as leader or resource in test method and process validations
  • Supports review of returned devices and reporting of findings to the Field Assurance department
  • Utilizes standard and advanced statistical analysis techniques to determine product acceptance, evaluate process capabilities, and develop statistically sound tolerance limits
  • Evaluates and recommends QA sampling plans based on desired confidence limits, process capabilities, and manufacturing/inspection methods and equipment
  • Proactively investigates, identifies, and implements best-in-class Quality Engineering practices
  • Supports continuous improvement in the production department
  • Trains operators as needed
  • Fully supports the Quality Policy by building quality into all aspects of the manufacturing work cycle and by maintaining compliance to all quality requirements in the manufacturing department
  • Evaluates, reviews and updates the product risk analysis documents to ensure risk controls adequately address and minimize potential patient safety risks in terms of user interface, design integrity, and process variation

PREFERRED KNOWLEDGE 

  • Statistics
  • Test method validation techniques
  • 21 CFR Part 820
  • Medical Device Directives
  • Canada’s Medical Device Regulations
  • ISO 13485:2003, Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes
  • BS EN ISO 14971:2012, Medical devices - Application of risk management to medical devices 
  • Appropriate knowledge and experience with risk analysis techniques or with similar device technologies, or qualifying experience by possession of relevant technical degrees or experience with the subject device through either design or process development experience

QUALIFICATIONS

  • A.A /BA degree or equivalent work experience in an engineering/technical position.
  • 3 to 5 years of medical device experience is preferred. 

ABILITY TO

  • Communicate effectively - oral and written 
  • Take initiative to meet deadlines and to work with minimal supervision as well as work collaboratively in a team based environment
  • Interpret and apply company policies and procedures appropriately
  • Lift 10 lbs
  • Sit for 90 % of time
  • Stand for 10 % of time
  • Comply with Hepatitis B immunization series

Click here to apply for the QUALITY ENGINEER position


Production Supervisor - Santa Rosa

Job Description

The Production Supervisor is responsible for managing a high performing operations team to meet production schedules while keeping quality as the number one priority. This individual will work cross functionally with Quality, Process Development, and R&D departments to continuously improve people and processes as they relate to safe and cost effective work practices within the value streams. Communication, delegation and organizational skills are required to provide for maximum throughput while assuring quality products, delivered on time to our customers, both internal and external. 

OVERALL RESPONSIBILITIES

  • Maintain organizational control of schedules, vacations, reporting and documentation, as required
  • Manage production schedules and deadlines
  • Report any problems and identify solutions that affect the ability to produce planned production
  • Drive Lean concepts and tools in the manufacturing process. Review current work practices to identify areas in which quality or productivity could be improved.
  • Foster strong interpersonal relationships and communication within and across departments
  • Challenge the workforce and the work environment to deliver high-performance results that provide cost-effective goods and services to our customers. Utilize process data to identify improvements in throughput and non-value added work
  • Manage employee morale and work to maintain a safe, injury-free work environment
  • Develop a culture that promotes employee safety and compliance with environmental standards
  • Review time punches daily for assigned staff; Capture and fix missed time punches for employees through the payroll system
  • Ensure that all quality and standard operating procedures are being followed
  • Identify training and development opportunities for team members

QUALIFICATIONS

  • Associate degree or equivalent work experience is required (Bachelor's degree is preferred)
  • 5+ years' experience as a production supervisor is required
  • 3+ years' experience in medical device as a production supervisor is preferred
  • Take initiative to identify improvement opportunities
  • Effective at communicating with and utilizing department resources and support groups
  • Able to interpret and apply policies and procedures appropriately
  • Develop a team environment with the ability to resolves conflicts with direct reports
  • Promote a requirement of working safely in a manufacturing environment to direct reports
  • Knowledgeable of efficient manufacturing layout and material flow techniques
  • Manage morale and welfare of individuals in the team
  • Take initiative to meet deadlines and works with minimum supervision
  • Knowledge of dial Calipers, rulers, and force gauges

Principal Regulatory Affairs Specialist - Santa Rosa

Job Description

This Regulatory position is in a dynamic environment and is mainly U.S. focused but there are many opportunities to work on worldwide projects. This position requires an individual that is dedicated to understanding the project technology, expanding product availability and has a strong work ethic.

OVERALL RESPONSIBILITIES

  • Prepare and evaluate regulatory strategies and plans for worldwide markets, with an emphasis on the U.S. Provide support and feedback to product development teams.
  • Prepare high-quality and well-organized U.S. submissions, 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 effectively with cross-functional team members and management, when required, to ensure project-specific regulatory strategy, process and timelines are met.
  • 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.
  • Interpret existing or new regulatory requirements and available research / information as they relate to company products and procedures, clinical studies, testing, or recordkeeping.
  • Complete other assigned tasks as required.

QUALIFICATIONS

  • BS or BA degree, preferably in a scientific discipline (or equivalent work experience) and 7-10 years medical device regulatory experience is highly preferred, including successful submissions and strategic planning.
  • Working knowledge of FDA, MDD and other international regulations pertaining to the design, manufacture and commercialization of medical devices. Experience in creating thorough and accurate domestic and/or international regulatory submissions and presenting 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 with the ability to appropriately adjust priorities.
  • Maintain a keen attention to detail, with the ability to detect errors and discrepancies, determine gaps in processes, and proactively mitigate them.
  • Work independently and be a collaborative team player with a positive attitude and creative problem solving skills.
  • Effectively communicate in writing and verbally.
  • Take initiative to meet deadlines through effective project and time management skills, strong planning and organization skills and practices, and to work with minimal supervision.
  • Compile and process thorough regulatory submissions using the current regulatory agency requirements.
  • Interpret and apply policies and procedures appropriately.

KNOWLEDGE of:

  • Computer Programs (including but not limited to Word, Adobe, Excel, PowerPoint, Database Management).
  • Electronic submissions


Territory Manager - U.S.

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.
Click here to apply for the TERRITORY MANAGER 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.