Software Project Engineer - RTP, NC
Date posted: August 22, 2008
Location: Research Triangle Park, NC
Job type: Full-time
Industry: Manufacturing
Description:
We are currently recruiting a talented Software Project Engineer who will be responsible for the design and develop innovative medical devices. This position entails hands on product development expertise dealing with several engineering and technology disciplines. Duties Include: Responsible for all aspects of software development and project management to develop software specifications, schedules, test plans, budges and day to day project management of medical device products •Hands on product development from design through testing of product effectiveness with responsibility for all aspects of the Software development process including V&V testing and production release •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 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 development 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
Qualifications: BS in Electrical Engineering or Computer Science or equivalent required (MS preferred) •Minimum five years experience in the medical device industry with a proven track record of software development and software project management. •In-depth understanding and experience with FDA, CE and ISO medical device regulatory requirements relative to Class II 510K medical devices •Hands on experience with proven results with C, C++, Flash programming, Imbedded systems and Windows application development from concept to production release •Hands on expertise with software verification and validation testing of medical devices meeting ISO 13485 and FDA cGMP •Experience working with and managing outside OEM vendors and/or consulting firms •Ophthalmic or dermatological market and product design experience •Venture backed company or small company experience •Ability to work with and maintain a professional and credible image with key physicians, consultants, vendors and co-workers •Strong communication skills
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.