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.
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.
Senior Manufacturing & Process Development Engineer
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.
- 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
- 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
This role is responsible for managing a high performing operations team to meet production schedules while keeping Quality as the number one priority. Works 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.
- 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 meet planned production targets.
- 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 team members’ training requirements and ensure that individuals are trained appropriately before assignment to a work detail.
- Identify development opportunities for team members.
- Associate degree or equivalent work experience is required. B.A. degree preferred.
- Five years experience as a production supervisor required.
- 3 years experience in medical device as a production supervisor preferred.
PREFERRED ABILITY TO:
- Supervise employees
- Take initiative to identify improvement opportunities
- Communicate effectively and utilize department resources and support groups
- Interpret and apply policies and procedures appropriately
- Develop a team environment and resolve conflict between subordinates
- Promote a requirement of working safely in a manufacturing environment to subordinates
- Manage morale and welfare of individuals in the team
- Take initiative to meet deadlines and work with minimal supervision.
PREFERRED KNOWLEDGE OF:
- Efficient manufacturing layout and material flow techniques
- Dial Calipers, rulers, and force gauges
- Must be able to lift 10 pounds
- Sits for 40% of time
- Stands for 60% of time
- Must wear clean room attire and adhere to grooming standards in that environment
- Temperature is cool within clean room and stent lab work environment
Facilities Maintenance Technician (I and II)
This position is responsible for the general maintenance of the facility. Other duties and responsibilities may be assigned as needed.
ESSENTIAL POSITION RESPONSIBILITIES:
- Provide clean room maintenance and cleaning on a weekly/monthly/as needed basis as required. Will insure good housekeeping practices are followed.
- Will perform general maintenance activities i.e. performing full janitorial services, changing light bulbs, fixing/assembling furniture, fixing locks, etc.
- Will handle and dispose of properly hazardous materials as needed in the course of job.
- May participate in the company Safety Committee representing the facilities department. Members of the evacuation and MERT teams. Trained to administer first-aid, CPR, and ADE (automated external defibrillators) devices.
- May assist with recreation, quarterly breakfast, and lunch coordination.
- Maintenance of shop and janitorial inventories and ordering supplies.
- Perform monthly preventative maintenance and equipment inspections. Will troubleshoot and fix equipment as trained.
- Processes and coordinates all internal facilities requests (cubicle/office set up, furniture acquisition, conference room set ups.
- May supervise a team of workers in the absence of or instead of the facilities supervisor. Duties will include scheduling, directing, and monitoring the work of other in the facilities maintenance department. (Facilities Maintenance
- Technician II only) Responsible for other services that may be needed by the company.
Facilities Maintenance Technician I –High School Diploma or equivalent and/or A.A. or equivalent work experience. 1+ years facilities work experience.
Facilities Maintenance Technician II – High School Diploma or equivalent and/or A.A. Degree or equivalent work experience with 3+ years work experience. Experience overseeing one or more technicians is helpful.
- Effectively communicates, both orally and in writing
- Takes initiative to meet deadlines
- Works with general supervision
- Customer service oriented
- Manages a multi-task job and appropriately adjust priorities
- Certified to operate the scissor lift, forklift, genie life, and floor machines.
- Installation and reconfiguring of office cubicles
Facilities Maintenance Technician I - PC operations, Microsoft Word/Excel, databases. General facility maintenance practices
Facilities Maintenance Technician II - PC operations, Microsoft Word/Excel, databases. Well honed facility maintenance practices. Supervisory experience helpful.
- Lifting up to 50 lbs.
- Carrying boxes up to 50 lbs.
- Pushing/Pulling up to 50 lbs.
- Climbing an 8 foot ladder.
- Raising Arms above head and moving them from side to side and in a circular motion while above the head for extended periods of time.
- Sits for 10% % of time.
- Stands for 90%% of time.
- Temperature is moderate to cold within work environment.
- Hepatitis B immunization series
Global Case Planning & Sizing Specialist
The Case Planning and Sizing Specialist will be part of the global case planning team that will support TriVascular’s product portfolio with device and case planning recommendations.
- Utilize three-dimensional (3D) reconstruction to evaluate computed tomographic (CT) datasets.
- Analyzes CT datasets to provide a device recommendation to physicians and clinical field personnel on the preoperative evaluation of an aortic abdominal aneurysm.
- Assist in the device and case planning training of physicians and clinical field personnel on TriVascular’s product portfolio.
- Work cross functionally and in collaboration with Sales, Marketing, Education, Quality, Customer Service and R&D.
- B.S. degree and/or advanced degree in health sciences, nursing, business and/or a related discipline (or equivalent work experience).
- 5+ years relevant clinical support experience preferably in the cardiovascular medical device industry.
- 1+ years experience viewing computed tomographic (CT) datasets with three-dimensional reconstructive software (or equivalent work experience).
- Communicate in English well both orally and in writing.
- Build strong, collaborative relationships with a diverse group of stakeholders
- Culturally sensitive
- Interact effectively with medical professional, and patients
- Make decisions in conjunction with stated business objectives of the company
- Operate with a strong integrity-centric ethic
- Highly detail oriented
- Act decisively and with sound judgment
- Takes initiative to meet deadlines
- Multi-task and manage conflicting priorities
- Work independently under minimal supervision
- Self-motivated – position may be home office based
- Travel domestically (20-25%).
- Experience with MS, PowerPoint, and Excel preferred.
- Endovascular therapy and devices
- Familiarity with computed tomographic (CT) and angiograms
- Three-dimensional reconstruction software to calculate anatomical measurements (i.e., OsiriX, TeraRecon, Vital Images, and 3Mensio).
- Must be able to lift 15 lbs.
- Sits for 95% of time. Stands for 5% of time.
- Close eye work. (100% of time)
- Temperature is moderate within work environment
Territory Manager - U.S.
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.
- 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.
- 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.
- 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.