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GEHC - System Designer III
Ref No.: 18-03204
Location: Marlborough, Massachusetts
Start Date / End Date: 05/21/2018 to 12/31/2018

Sr. Lead System Design Engineer - Hardware

As a Lead System Design Engineer, you will be accountable for the design of customized and modified single-use bioreactors and mixers delivered from the department Custom design HW. The position has design responsibility to ensure that products achieve all design objectives required to meet customer and business needs, including: feature and functionality, quality, reliability, serviceability, manufacture-ability, regulatory, compliance and cost. The LSD must understand and capture the user needs into modified system requirements and is responsible for the architectural decomposition and allocation to subsystems.

Responsibility areas include:

• Overall design responsibility during execution of customer or Client internal projects
• Ensure that applicable customer URS requirements are tracked and fulfilled
• Regulatory compliance fulfilment of delivered products
• Represent Client in technical discussions with customers during a project
• Participate in meetings at customer site when required
• Lead field issues investigations and address CAPA
• Coordinate the detailed design and solve any issues during design phase
• Facilitate tasks and be informed of Automation/Software aspect of the design
• Responsible for design transfer to manufacturing
• Approval of test plans
• Chair technical design review meetings

Beyond that a Lead System Design Engineer also has a support role for

• Product Care investigations and questions
• Provide technical input to sales engineers during the RFQ phase
• Manufacturing investigations - related to design
• Mentoring and support junior engineers and consultants
• Review improved Ways of Working, including instructions
• Investigations regarding Design related production issues
• To act as a contact person for design related questions

Lead System Design Engineer authorities

• Overall approval of the design in specific customer product
• Ensure regulatory requirements are fulfilled in all projects
• Direct contact with suppliers for technical discussion and quotations
• Make design decisions in regards to change orders and regulatory findings

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. Identify continuous improvement activities by initiating the implementation of process and product quality improvement initiatives

1. Bachelor's Degree in Engineering/Science
2. 15+ years of progressive on the job experience as an engineer or scientist within the appropriate field of study
3. 5+ year experience in project leadership within a manufacturing, development or research environment, including previous work with global and/or virtual teams.
4. Demonstrated experience driving CTQ flow-down to subsystems
5. Demonstrated broad exposure to HW/SW/Systems design and technical depth in one or more engineering disciplines (Electrical, Mechanical, Software, etc)

Preferred Qualifications:
1. Masters Degree in Engineering (Mechanical or Electrical)
2. Demonstrated technical leadership capability in integration activities
3. Experience with regulated industries (GMP)
4. Creative problem solver and solution developer when presented with conflicting requirements, business demands and technical risks/issues
5. Strong interpersonal skills
6. Creative, able to lead a team and be accountable for team results in order to deliver a high-quality product on time

• Must be legally authorized to work in the United States full-time
Does the position allow for the worker to be virtual/remote?  
Shore Options Available for this Position  
Onshore Only
Hours per Day 8
Hours per Week 40
Total Hours 1,288.00