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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| Quality Engineer II |
| JOB FUNCTION: |
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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: |
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• Functions as the Quality Assurance team member from the Concept Phase through
• Market Release of the Company projects.
• Sup00000port the development and deployment of world class quality system
• that meets corporate objectives within applicable regulations and guidelines.
• Support the development and deployment of world class quality system
• that meets corporate objectives within applicable regulations and guidelines.
• Support regulatory audits including FDA, ISO 13485, and Internal audits.
• Ensure that all observations or nonconformances are properly rectified.
• Participate in Design Control activities including Risk Management activities
• (dFMEA, pFMEA) and ensure these projects 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
• and data analysis.
• Identify new processes as they relate to Quality System requirements to confirm
• all verification and validation needs are being met.
• Prepare Quality Plans as needed.
• Support setup of Design History Files and Technical Files for all projects as required.
• Review/approve Design Verification, Qualification, and Validation Test Plans.
• Support/lead Test method validation.
• Solid understanding of FDA Quality System Regulation, GMP Guidelines, ISO 13485,
• and other international regulatory requirements.
• Successful 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.
• Familiar with Statistical techniques (such as Minitab and JMP).
• 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.
• Performs other duties and projects as requested. |
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| Other Duties and Responsibilities: |
• Coordinate the identification, assignment, monitoring, and completion of product
• improvement projects in cross-functional teams.
• Ensure lot release testing is adequately performed.
• Auditing experience is a plus. |
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| EDUCATION AND REQUIRED: |
• 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 4 plus years of work experience in the medical device industry. |
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| Communication Skills: |
Good written, verbal, interpersonal, and time management skills.
Special skills, abilities, and requirements: None required.
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| 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.
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Other Essential Knowledge, Skills, and Abilities:
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• Ability to work well under pressure and to meet multiple and occasional competing deadlines
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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. |
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EDUCATION:
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| B.S. Engineering |
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TRAINING AND EXPERIENCE:
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| 3-6 years medical design experience in medical device/clinical environment. |
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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. |
