System Engineer - Medical Imaging

Location: Highland Heights, OH 44143

Terms: Long Term Contract Employment – Possible to Direct

Overview:

• This is a System Engineer role in the Medical Imaging field.
• The system engineer is responsible feature-level technical leadership and contribute to technical realization of a product release/lifecycle management.
• The scope includes translation of user requirements, requirements management, technical approach, design specification and interfaces, feasibility of potential solutions, allocation of derived requirements and traceability, design reviews, integration coordination, technical liaison to the program, technical roadmap, defect management/root cause analysis and risk management.
• Feature technical leadership and responsibility as part of a new product release or sustaining activities.
• Experience in a Requirements Management tool (eg. Rational RequisitePRO or DOORS) and problem reporting/defect tracking tools such as Rational ClearQuest.
• Translation of user requirements, requirements management, top level design, feasibility of potential solutions, decomposition of derived requirements.
• Design reviews, Integration coordination, Technical liaison to engineering, Defect management and Risk management.
• Medical diagnostic industry awareness.

Education:

Bachelor of Science in Systems, Mechanical, Electrical, Computer Science, Physics, Biomedical Engineering or equivalent degree in a Scientific/Engineering discipline, alternatively 4 years professional industry experience in the relevant technical discipline 3-5 years of experience in an engineering role beyond the educational qualification.

Experience that Would Be a PLUS:

• Evidence of practical knowledge of standards and regulations pertaining to the medical device industry, both domestic and international. This includes but is not limited to organizations such as FDA, IEC, ISO, CFDA, ACR, AAPM, COCIR, MITA and other directives such as RoHS and WEEE. Examples include: FDA 21CFR820.30, IEC 60601-1 and ISO 14971.
• Proven excellence in technical leadership in a matrix environment, including demonstrated ability to influence indirect resources.
• System modeling simulation.