General Electric Marlborough , MA 01752
Lead Systems Engineer- Cell Therapy
Posted 9/27/2018 11:56:40 AM
Job Function: Engineering/Technology
Business Segment: Healthcare Life Sciences
Location(s): United States; Massachusetts; Marlborough
GE Healthcare is looking for an Lead Systems Engineer who will be part of a multidisciplinary R&D team developing medical devices and manufacturing equipment aiming to process biological cells in the field of blood transplantation and cellular therapies. The Systems Engineer will be accountable for developing a roadmap strategy, bridging and participating in the project execution with team members, define and execute the test plan along with engineering and biological related fields.
Define the systems architecture in conjunction with the concept design, and generate requirements structure accordingly,
Oversight of infrastructure including installing, configuring, testing and maintaining operating systems, hardware, application software and system management tools
Monitor and test performance of applications, foreseeing potential bottlenecks and identifying possible solutions
Work with the SW, HW, Disposable, Biology technical leads, Product Managers and Program Manager and ensure that there is an integrity on the overall requirements structure, requirements are captured correctly, gaps and risks are identified and communicated with stakeholders.
Ability to create lower level requirements to execute verification and support product validation, and generating trace matrix,
Decompose high-level business and user requirements into functional requirements and quality, specified in an appropriate level of detail suitable for use by those must base their work on the requirements.
Organizational skills, to work with the vast array of information gathered during elicitation and analysis and to cope with rapidly changing information
Interpersonal skills, to help negotiate priorities and to resolve conflicts among project stakeholders
Lead requirements analysis and verification, ensuring that requirement statements are complete, consistent, concise, comprehensible, traceable, feasible, unambiguous, and verifiable, and that they conform to standards.
Participation on testing planning with the engineering lead, generating testing plans compliantly with requirements and leading the efforts on requirements verification activities
An understanding of contemporary requirements elicitation, analysis, specification, verification, and management practices and the ability to apply them in practice; familiarity with requirements engineering books and resources
Write requirements specifications according to standard templates, using natural language simply, clearly, unambiguously, and concisely.
Participate in executing the development and performing verification and validation activities with focus on quality, compliance and execution rigor.
Lead the technical project roadmap involving proof-of-concept, design, manufacturing and V&V.
Close R&D collaboration with the project manager, engineering and biological team, and take the lead to translate between the parties facilitate the achievement of a successful system.
University degree or equivalent in related scientific or engineering fields (physics, mechatronics, mechanics, electronics, biomedical or similar fields)
8+ years of successful experience working in product development in a multidisciplinary environment, ideally involving broad HW/SW development activities in life science or medical fields.
Experience in DOORS requirements management tool preferred
Understanding multi engineering disciplines, such as mechanical, electrical and SW engineering
Demonstrated ability to clearly communicate (oral, written) across global, cross-cultural, cross-functional teams and stakeholders
Understanding complex system development methodologies
Experience in system testing in both component level and highest system integration level
Well-founded knowledge and practical experience of relevant regulations (ISO 9001, ISO13485, cGMP), specifically for the US and European market
GE (NYSE:GE) drives the world forward by tackling its biggest challenges. By combining world-class engineering with software and analytics, GE helps the world work more efficiently, reliably, and safely. GE people are global, diverse and dedicated, operating with the highest integrity and passion to fulfill GE's mission and deliver for our customers. www.ge.com
GE offers a great work environment, professional development, challenging careers, and competitive compensation. GE is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.
Locations: United States; Massachusetts; Marlborough
GE will only employ those who are legally authorized to work in the United States for this opening.