Electrical Design Engineer - RTP, NC
Date posted: August 22, 2008
Location: Research Triangle Park, NC
Job type: Full-time
Industry: Manufacturing
Description:
We are currently seeking an experienced Electrical Design Engineer to design and develop innovative medical devices. This position entails hands on product development expertise dealing with several engineering and technology disciplines. Duties Include: Apply engineering knowledge, electronic control and product design skills to the design and development of new products as defined by the company’s business objectives as well as product changes, enhancements and appropriate test methodologies. •Hands on product development from design through testing of product effectiveness with responsibility for all aspects of the electronic design, development and production of companies products including circuit testing, bread-boarding, debugging and validating product and production procedures. •Plan, schedule, and complete projects in an aggressive manner consistent with company objectives. •Contribute to the intellectual property position of the company via invention and patent applications. Maintain accurate documentation and log books of concepts, designs, drawings, and processes. •Maintain current knowledge of competitive technologies in addition to medical, technical, and biomedical developments related to company products and markets. •Work with company mechanical engineers and external design firms to develop, test and release to production medical devices consisting of thermal and pneumatic control circuits, imbedded microprocessor circuits and associated peripherals •Work within and maintain ISO 13485 and GMP systems, including pre-production quality assurance procedures, pre-clinical testing programs, and post-production GMP 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 outsourcing partners to coordinate production of new products for clinical trials along with providing for product testing, efficacy and safety analysis requirements for regulatory and clinical submissions. •Support company goals and objectives, policies and procedures, Good Manufacturing Practices (cGMP), and FDA, MDD and MOH regulations. •Ability to work with and maintain a professional and credible image with key physicians, consultants, vendors and co-workers.
Qualifications:
BSEE or equivalent required (MSEE preferred)
•Minimum five years experience in the medical device industry with a proven track record of product design and development. In-depth understanding and experience with FDA, CE and ISO medical device regulatory requirements relative to Class II 510K medical devices
•Design experience with microprocessor circuit board development and imbedded software development from concept to production release.
•Expertise in Windows XP imbedded, flash, and C programming.
•Expertise in FPGA designs using Verilog and Quartus tools
•Hands on expertise in microprocessor design and development with experience with
reliability and regulatory testing.
•Board level design and debug with experience with temperature controllers and motor
and motion controllers.
•Experience working with outside OEM vendors and/or consulting firms.
•Ophthalmic or dermatological market and product design experience. Venture backed company or small company experience.
Our Client offers a competitive salary and exceptional benefit package. For confidential consideration please submit a resume and salary history to: claire@fullscalesolutions.com Full Scale Solutions is an equal opportunity employer.
Category: Pharmaceutical/Biotech
Company: Full Scale Solutions
Full Scale Solutions, Inc. is a Human Capital management company that provides exceptional recruiting solutions to companies to help them grow.