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. Accountant |
| JOB FUNCTION: |
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Medical device R&D/Manufacturing Company is looking for Sr. Accountant to play a key role in their accounting department. The ideal candidate is detail-oriented, well-organized, self-starter, collaborative team-player. |
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| Responsibilities: |
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• Responsible for full cycle of accounting functions include journal entries, GL accounts reconciliations,
• financial statements preparation, and balance sheet analysis.
• In charge of month end close processes and day to day operations in Accounting Department.
• Perform monthly bank and credit card statement reconciliations.
• Preparation of weekly cash flow report for 12 cycles.
• Support annual budget processes.
• Preparation of PBC requests conducted by independent accounting firm.
• Maintain and update Accounting policies and procedures.
• Employees and Consultants expenses reimbursement.
• Provide support to other teams across the company as needs arise, including special projects or
• ad-hoc assignments as required.
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| Education/Qualifications: |
• 5+ years overall experience in Accounting/Finance.
• Proficient in MS Excel skills.
• Knowledge and experience in Sage 50 Peachtree Accounting preferred.
• BS degree in Accounting / Finance.
• Manufacturing experience preferred.
• Efficient, reliable, flexible and adaptable to change.
• Strong attention to detail, analytical and problem solving skills,
• with a high degree of accuracy.
• Capacity to multi-task and prioritize.
• Ability to work independently and a self-starter.
• Team player a must. |
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| 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
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objectives within applicable regulations and guidelines.
• Support regulatory audits including FDA, EU, Japan and Internal audits. Ensure that
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all observations
or nonconformances are properly rectified.
• Participate/drive IQ/OQ/PQ projects.
• Participate/drive the Design Control activities. Ensure all Risk Management activities
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(dFMEA, pFMEA) are executed and maintained according to all regulatory standards.
• Support new product development activities through the development, review, and approval
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of design verification/validation and process verification/validation protocols, reports,
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and data analysis.
• Identify new processes as they relate to Quality System requirements to confirm
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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
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Regulation, ISO 13485, and other international regulatory requirements.
• Successful hands-on experience in the transfer of Class II & III medical devices to production
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and market release.
• Must have technical, hands-on background with capabilities of proactively addressing
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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 process.
• 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.
• Perform other duties and projects as assigned.
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Other Duties and Responsibilities:
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• Coordinate 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 . |
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EDUCATION & COMMUNICATION SKILLS:
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• 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. |
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| R&D ENGINEER I |
| JOB FUNCTION: |
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Responsible for providing creativity to the mechanical engineering design and development of new invasive and non-invasive medical device products. |
| DESCRIPTION OF DUTIES: |
| Essential Duties and Responsibilities: |
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• Functions as the Quality Assurance team member from the Concept Phase through
• Market Release of the Company projects.
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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. |
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| 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. |
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| EDUCATION : |
| • B.S. Engineering or AA degree & equivalent professional working experience |
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| EXPERIENCE : |
| • 1-3 years medical design experience in medical device/clinical environment. |
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| WORKING ENVIRONMENT: |
Job duties are primarily performed in an office environment utilizing standard office
equipment such as a computer, photocopier, and telephone. The noise level in the
work environment is usually low to moderate.
May require some job duties to be performed in a laboratory environment that requires
special clothing and practices and requires strict adherence to departmental and
standard operating procedures.
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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. |
