Location(s): United States; Massachusetts; Westborough
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Role Summary: This is a technical leadership role that will address customer-requested custom projects (bioprocess systems hardware design). Responsible for system level trade-off and decisions, contribution to requirements and customer interface documents, and work independently with the immediate team and other teams across business.
Essential Responsibilities: • Execute the design, analysis, or evaluation of assigned projects using sound engineering principles and adhering to business standards, practices, procedures, and product / program requirement • Be responsible for System design including general specification, P&IDs, component sizing, selection, detailed equipment specifications • Define and manage Interfaces to all sub-system in compliance to the system solution • Work with SMEs to generate and execute design reviews • Work closely with other members of the project teams in providing sound technical advice on feasibility and technical risks associated with any new project opportunity • Collaborate with technical experts in order to manage technical risks within project activity • Ensure the development of functional verification and qualification documentation in conformance with master plans and programs • Document control and assembly of engineering documents in support of operation • Work within GEHC Quality Management System Quality Specific Goals: 1. Aware of and comply with the GEHC Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position. 2. Complete all planned Quality & Compliance training within the defined deadlines. 3. Identify and report any quality or compliance concerns and take immediate corrective action as required. 4. Support compliance/closure of Regulatory and Quality requirements before completing Design Outputs/Program Deliverables. 5. Participate in continuous improvement activities by supporting the implementation of process and product quality improvement initiatives.
Qualifications/Requirements: 1. Bachelor's Degree in Mechanical engineering, Electrical Engineering, Software Engineering, Computer Science, Industrial Engineering, or related field. 2. Minimum of 5 years hands-on design and implementation experience involving; Engineering Systems, Hardware / Software Engineering, and/or Electrical Design 3. Strong interpersonal skills, including good technical communication. 4. Previous project or team experience.
Desired Characteristics: 1. MS or PhD in Electrical Engineering or equivalent experience 2. Demonstrated technical leadership capability in integration activities 3. Self-starter, energizing, results oriented and able to multi-task 4. Excellent teamwork, coordination and communication skills 5. Ability to meet aggressive reliability, performance, cost, serviceability, and delivery targets 6. Effective oral and written communication skills 7. Experience with regulated industries (GMP, GAMP) 8. Global project experience 9. Knowledge of governing regulations, specifically 21CFR211 and Eudralex Volume 4 Annex 11 10. Knowledge of UL and IEC (e.g., UL 508A, EN 60204-1) standards and how they apply to designs 11. Working knowledge of GEHC tools and processes ePDM, AutoCAD Electrical, Phase Review Discipline (PRD)
Locations: United States; Massachusetts; Westborough
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