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| Manufacturing Engineer - Job # 1920 |
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Client Synopsis:
Full Scale Solutions is currently recruiting for the following position. Our Client is a rapidly growing, privately held medical device company based in Raleigh-Durham NC.
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Essential Duties and Responsibilities:
We are currently seeking a Manufacturing Engineer to manage the transfer of several medical devices from R&D to manufacturing. This position entails hands-on development of automated test fixture and the creation of production procedures within the ISO 13485 medical device quality system.
Responsibilities include but are not limited to:
- Apply engineering knowledge, electrical, mechanical and software design skills to the development of automated and semi-automated manufacturing test fixtures along with associated production procedures including process validation documentation.
- Work within and maintain GMP and ISO13485 systems, including pre-production and postproduction compliance in coordination with the Document Control, Clinical, Regulatory and Quality Assurance requirements.
- Provide support in the resolution of product complaints and/or safety issues.
- Work with companies outsourcing partners to coordinate pilot production of new products for Clinical trials along with providing for product testing, efficacy and safety analysis requirements for regulatory submissions.
- Coordinate the transfer of technology to contract manufacturer(s) and take the role of liaison between and R&D and the contract manufacturer.
- Plan, schedule, and complete projects in an aggressive manner consistent with company objectives.
- Support company goals and objectives, policies and procedures, Good Manufacturing Practices (cGMP), and FDA, MDD and MOH regulations.
- Contribute in cost reduction initiatives and help in the selection of both state-side and offshore contract manufacter(s).
- Maintain current knowledge of competitive technologies in addition to medical, technical, and biomedical developments related to company products and markets.
- Regularly make presentations and updates to management regarding project status.
- Ability to work with and maintain a professional and credible image with key physicians, consultants, vendors and co- workers.
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Requirements:
- BSEE or equivalent required.
- Minimum five years experience with a proven track record of FDA Class I/II medical device manufacturing engineering.
- Hands on CAD/CAM experience with schematic entry software like ORCAD.
- Hands on software programming experience with C, C++, Basic or other languages used in automated manufacturing.
- In-depth understanding and experience with FDA, CE and ISO medical device regulatory requirements relative to Class II and III 510K and PMA medical devices.
- Medical Device experience.
- Venture backed company or small company experience.
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 Our Client offers a competitive salary and exceptional benefit package.
For confidential consideration please submit a resume and salary requirements to
claire@fullscalesolutions.com.
Full Scale Solutions is an equal opportunity employer.
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