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Careers
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Thank you for your interest in Avantec Vascular. Our employees share a commitment to innovation, exchange of ideas and teamwork in a dynamic, rewarding environment. We are committed to maintaining a diverse workforce, quality work environment, and excellent benefits. We seek smart, talented, and driven individuals to join our team. 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 click on the job link below.


Summary of Current Openings
Sr. Quality Engineer
R&D Eng
 

Benefits Summary
Avantec Vascular offers a comprehensive, competitive compensation and benefits package to help care for employees and their families. Benefits offered by Avantec include:

+ Personal Time Off (accrued over the year)
+
sick Time
+ Holidays
+
Medical, Dental and Vision
+ Life Insurance
+ Long Term Disability
+ 401k Retirement Plan (employees are eligible first of the month following hire date)
+ Employee Assistance Program

 
 
Sr. Quality Engineer
JOB FUNCTION:

Ensure that the company is adhering to its Quality Policy and Quality System. Provides
Quality Assurance support to new product development projects from the Concept Phase
through the Market Release Phase. Most important responsibility is ensuring that product
used for human use has undergone the requisite quality control checks.

DESCRIPTION OF DUTIES:
Essential Duties and Responsibilities:
 
• Functions as the Quality Assurance team member:
From the Concept Phase through Market Release of the Company projects.
• Support the development and deployment of world class quality system
that meets corporate objectives within applicable regulations and guidelines.
• Support regulatory audits including FDA, EU, Japan and Internal audits.
Ensure that all observations or nonconformances are properly rectified.
• Participate/drive IQ/OQ/PQ projects.

• Participate/drive the Design Control activities. Ensure all Risk Management
activities (dFMEA, pFMEA) are executed and maintained according to
all regulatory standards.
• Support new product development activities through the development, review,
and approval of design verification/validation and process verification/validation
protocols, reports, and data analysis.
• Identify new processes as they relate to Quality System requirements
to confirm all verification and validation needs are being met.
• Prepare Design Quality Plans as needed.
• Participate/Approve Design Verification, Qualification, and Validation Test Plans.
• Develop and validate new test methods as needed.
• Owns the supplier evaluation process.

• Solid understanding of FDA Quality System Regulation, GDP, GMP Guidelines,
EU Medical Device Regulation, ISO 13485, and other international
regulatory requirements.
• DSuccessful hands-on experience in the transfer of Class II &
III medical devices to production and market release.

• Must have technical, hands-on background with capabilities of proactively
addressing and solving issues rather than solely identifying issues.
• Knowledge of Statistical software techniques (such as Minitab and JMP).
• Conduct statistical analysis and generate trend reports for projects on
an as-needed basis.
• Utilize Quality Engineering tools and techniques to establish sampling plans,
develop quality plans, test methods, conduct process and systems audits,
and assist in specification development.
• Support Cleanroom/CER monitoring, track and analyze relevant data.
• Owns/Support Calibration/PM process.
• Support CAPA processe.
• Owns Complaint Process. Lead investigations of product and field complaints,
root cause and failure analysis to ensure complete closure.
• Evaluate incoming, in process, and final quality inspections and tests
for effectiveness and adequacy.
• Perform R&R studies as needed, validate test methods for new tests,
assess and improve inspection tools and fixtures when needed.
• Understand the requirements for sterilization validation and completes/
review protocols and reports. Manage sterilization re-validation when needed.
• Performs other duties and projects as assigned.
 
Other Duties and Responsibilities:
• MCoordinate the identification, assignment, monitoring, and completion
of product improvement projects in cross-functional teams.
• Ensure lot release testing is adequately performed.
• Working knowledge of Japanese MHLW and PMDA is a plus.
 
EDUCATION & COMMUNICATION SKILLS:
• Minimum of Bachelor’s degree in Biomedical, Mechanical, or Biomedical Science
or related degree.
• Under certain circumstances, and at Management’s discretion, specific training
and/or experience may fulfill the requirements of this position.
• Minimum of 7 plus years of work experience in the medical device industry.
• ASQ CQE or other certificates are a plus.
• Good written, verbal, interpersonal, and time management skills.

Special skills, abilities, and requirements: None required.

 
 
R&D Eng
JOB FUNCTION:
Responsible for providing creativity to the mechanical engineering design and development of new invasive and non-invasive medical device products.
DESCRIPTION OF DUTIES:
• Researches, develops, designs (utilizing CAD design software), and evaluates technical suitability
of mechanical and electro-mechanical materials, components, assemblies, processes and/or
equipment. Must be able to clearly communicate designs and all requisite requirements to
support personnel both verbally and in writing.
• Conducts feasibility studies to verify capability and functionality.
• Develops and implements new concepts from initial design to market release.
• Directs support personnel and coordinates their project activities.
• Manually builds prototypes in accordance with engineering instructions, drawings and specifications.
• Sets-up and manually operates routine and non-routine test equipment.
• Writes and submits intellectual property (patents) invention disclosures.
• Documents detailed drawings and specifications throughout all phases of research and development.
• Reviews or coordinates supplier activities to support development.
• Analyzes, recommends and implements process improvements that reduce lead-time, eliminate
non-valued added work, improve yields, and improve process capabilities.
• Works in accordance with quality system procedures.

Other Essential Knowledge, Skills, and Abilities:

• Ability to work well under pressure and to meet multiple and occasional competing deadlines
while maintaining a cooperative working relationship with other employees and supervisor.
• Proficiency with CAD, word processing, spreadsheet, project management software applications.
• Ability to attend human clinical cases and interact the hospital staff in a constructive and
professional manner.
• Knowledge of interventional medical products and technologies, especially catheters,
vascular access devices and guide wires.
• Knowledge of medical device industry regulatory requirements including design and
control practices, GMP’s and GLP’s.
• Has been on a team through a project development cycle.
 
EDUCATION:

B.S. Engineering
 
TRAINING AND EXPERIENCE:

3-6 years medical design experience in medical device/clinical environment.
 
 
 
 
Sr R&D Eng
Essential Duties and Responsibilities:
• Applies intensive and diversified knowledge of engineering principles and practices to the research,
development, design and evaluation of technical suitability of materials, components, assemblies,
processes and/or equipment. Clearly communicates designs and all requisite requirements to
support personnel both verbally and in writing.
• Contributes to, develops and/or performs marketing and engineering specifications, feasibility
plans/studies/reports, cost estimation/analysis, design reviews, risk and hazard analyses,
FMEAs for Design/Process/Use, product verification and validation testing.
• Documents detailed drawings and specifications throughout all phases of research and development.
• Directs support personnel and coordinates their project activities.
• Develops new and/or modifies existing processes, tooling and fixtures to improve performance or
increase efficiencies and yields in production.
• Reviews or coordinates supplier activities to support development.
• Analyzes, recommends and implements process improvements that reduce lead-time,
eliminate non-valued added work, improve yields, and improve process capabilities.
• Manually builds prototypes in accordance with engineering instructions, drawings and specifications.
• Writes and submits intellectual property disclosures (patents).
• Attend animal studies as needed.
• Ensures appropriate communication processes are established within and across functional groups.
Communicates information related to quality management system effectiveness.
• Work in accordance with quality system procedures.
• Other duties as assigned.
• Participate in FMEA analyses.
• Participate in patent reviews and generate intellectual property, applicable to the Company’s
clinical platforms.


EDUCATION:

BS degree in Biomedical, Mechanical, or Biomedical Science or related degree. Under certain circumstances, and at Management’s discretion, specific training and/or experience may fulfill the requirements of this position.
 
TRAINING AND EXPERIENCE:
Required:
7-12 years medical design experience in medical device/clinical environment. Uses required safety equipment when performing lab work and animal/cadaver lab work.

• Ability to Function as the Project Leader from the Concept Phase through Market Release of
Avantec Vascular projects
• Ability to work well under pressure and to meet multiple and occasional competing deadlines while
maintaining a cooperative working relationship with other employees and supervisor.
• Proficiency with SolidWorks/CAD, word processing, spreadsheet, project management software
applications.
• Ability to attend human clinical cases and interact the hospital staff in a constructive and professional
manner.
• Knowledge of vascular interventional neuroradiology medical products and technologies,
especially catheters, vascular access devices and guidewires.
• Knowledge of medical device industry regulatory requirements including design and control practices,
GMP’s and GLP’s.
• Strong analytical and communications skills.
 
Positions Supervised:
Direct: R&D Engineer, R&D Technician (all Levels)
Indirect: R&D Engineer, R&D Technician (all Levels)
 

Message to Recruiters
The Human Resources Department manages all employment activities at the company.
To protect the interest of all parties, Avantec Vascular requires all recruiters to present a signed agreement prior to submitting any candidates. Submission of unsolicited resumes from recruiters who do not have a signed agreement in place does not create any implied obligation on the part Avantec Vascular. If you are a recruiter interested in developing a relationship with Avantec Vascular please contact the HR department. Recruiters are requested not to contact Avantec Vascular employees directly.
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Submit CV:

Email your CV or resume (doc,docx,pdf,txt,gif,jpg,jpeg,png) to our Human Resources Department at hr@avantecvascular.com

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Avantec Vascular Corporation : 408-329-5400
870 Hermosa Ave. Sunnyvale, CA 94085
Copyright (c) 2012 Avantec Vascular Corporation. All Rights Reserved.
 
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E-mail : hr@avantecvascular.com