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
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
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| RA/QA Manager |
DESCRIPTION OF DUTIES:
Essential Duties and Responsibilities:
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Primary job focus is to ensure that the company is adhering to its Quality Policy. Provides Quality Assurance support to 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. The Quality Assurance Manger receives direct supervision from the CEO, but shall be relatively autonomous and proactive in addressing their project responsibilities. As required, the Quality Assurance Manager shall elicit guidance from Senior Staff (RA, CTO, Operations) and members of the project teams. Responsibilities include: |
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| Responsibilities: |
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• Ensure lot release testing is adequately performed.
• Perform internal quality audits and manage all quality records.
• Act as Management Representative and perform Management Reviews.
• Responsible for the audits of Avantec Vascular by outside agencies; ensure that all observations
• or nonconformance’s are properly rectified.
• Ensure that product sterilization is adequately controlled and validated.
• Manage continuing cleanroom validations
• Setup and manage Design History Files and Technical Files for all projects as required
• Approve Design Verification, Qualification, and Validation Testing Plans
• Develop and review Quality Plans
• Assist in preparation of regulatory submissions
• Champion sterilization validation, biocompatibility testing, packaging validation, etc.
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required for the submission package
• Perform supplier audits and ensure that suppliers are approved.
• Directly supervise engineering and technician support in appropriate product, process
• or component testing.
• Manage the Product Complaint process.
• Participate in FMEA analyses.
• Provide input to project schedule and budget.
• Provides input to Regulatory Affairs to fulfill In-vitro and In-vivo data requirements
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for submissions.
• Supports the Avantec Vascular Quality Policy and Quality System
• Performs other duties and projects as requested. |
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| 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.
• Solid 6 + years of disposable, medical device experience in the area of Quality Assurance.
• Solid understanding of FDA Quality System Regulation, GMP Guidelines,
• Medical Device Directive, and ISO13485.
• Successful hands-on experience in the transfer of Class 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. |
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| SR. R&D ENGINEER |
| JOB FUNCTION: |
Responsible for product development activities that encompass the design, testing,
fabrication and validation of systems and devices as well as ancillary systems that
may be necessary to meet company goals and objectives. This individual will also be
expected to provide leadership, mentoring and directing other engineers and
technicians in the organization. The incumbent will interact with cross functional
team members from a wide range of AVC departments in multiple geographic
locations as well as with suppliers and customers. |
| DESCRIPTION
OF DUTIES: |
• Applies intensive and diversified knowledge of engineering principles and practices to
• the research, development, design and evaluation of technical suitability of materials,
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components, assemblies, processes and/or equipment. Clearly communicates designs
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and all requisite requirements to support personnel both verbally and in writing.
• Contributes to, develops and/or performs marketing and engineering specifications,
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feasibility plans/studies/reports, cost estimation/analysis, design reviews, risk and
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hazard analyses, FMEAs for Design/Process/Use, product verification and validation
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testing.
• Documents detailed drawings and specifications throughout all phases of research
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and development.
• Directs support personnel and coordinates their project activities.
• Develops new and/or modifies existing processes, tooling and fixtures to improve
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performance or increase efficiencies and yields in production.
• Reviews or coordinates supplier activities to support development.
• Analyzes, recommends and implements process improvements that
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reduce lead-time, eliminate non-valued added work, improve yields, and improve
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process capabilities.
• Manually builds prototypes in accordance with engineering instructions, drawings
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and specifications.
• Writes and submits intellectual property disclosures (patents).
• Attend animal studies as needed.
• Ensures appropriate communication processes are established within and across
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functional groups. Communicates information related to quality management system
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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
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the Company’s clinical platforms.
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EDUCATION:
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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:
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7-12 years medical design experience in Neurovascular 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
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Release of Avantec Vascular projects
• Ability to work well under pressure and to meet multiple and occasional competing
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deadlines while maintaining a cooperative working relationship with other employees
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and supervisor.
• Proficiency with SolidWorks/CAD, word processing, spreadsheet, project
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management software applications.
• Ability to attend human clinical cases and interact the hospital staff in a constructive
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and professional manner.
• Knowledge of vascular interventional neuroradiology medical products and
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technologies, especially catheters, vascular access devices and guidewires.
• Knowledge of medical device industry regulatory requirements including design and
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control practices, GMP’s and GLP’s.
• Strong analytical and communications skills. |
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Positions Supervised:
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| Indirect: R&D Technician (all Levels) |
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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. |
