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DR-08-05-SMLCE Engineering Section Manger - LCE Validation - Information Technology, Telecommunications |
SUMMARY: Directs and coordinates activities of LCE [Life Cycle Engineering] department to enhance, manufacture, and test components, products, and systems.
RESPONSIBILITIES:
• Directs department activities to enhance existing designs, improve production techniques, and develop test procedures.
• Analyzes technology trends, human resource needs, and market demand to plan projects
• Confers with management, production, and marketing staff to determine engineering feasibility, cost effectiveness, and customer demand for existing products.
• Forecasts operating costs of department and directs preparation of budget requests
• Advises management of new developments which may affect profit, schedule, costs, customer relations, and/or inter-departmental relations.
• Maintains a working knowledge of new technologies which may improve operations, and develops recommendations accordingly.
• Manages a multi-disciplined design team of mechanical, electrical and software engineers including direction of support staff activities of designers, drafters and technicians
• Directs the entire product life cycle process and ensures, design compliance for scope, quality, reliability, manufacturability, cost and serviceability.
• Directs the generation of formal test protocols, reports, trend data and supports the documentation of LCE Verification and Validation activities needed to meet internal and external requirements, specifications and standards.
• Reviews Final LCE Verification & Validation protocols and procedures required for formal qualification.
• Directs the effective management of personnel to include performance management, objective setting and development.
REQUIREMENTS:
• BS in Engineering (ME/EE/SW); prefer MS
• Ten to fifteen years in the development of complex embedded systems including five plus years in management. Experience in a medical devices preferred. Skilled in the management of multi-disciplined engineering teams in an FDA regulated environment.
• Thorough understanding of GMPs as defined by the FDA; familiarity with UL, CSA, IEC and other various regulatory standards.
Location: Andover, MA
Duration: Full time position
Target compensation: DOE
Reports to: VP, Research and Development
Department: Research and Development
If you have interest in this position, please contact me immediately.
GTT has over 8 years of experience in IT consulting, including staff augmentation and project engagements. We offer health insurance, 401K, and disability insurance to W2 employees. Also, we will contract on a Corp to Corp basis.
Please send Word version of resume to medicaldevicejobs@grouptechinc.com
and reference this ad when applying.
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