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Sr. System Engineer-Project Manager Job Details

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Sr. System Engineer-Project Manager (Ref: 1155157)
Sector, Sub Sector: Other
Compliance Type: Regulatory/Compliance
Expertise: -
Company: GE Commercial Finance
Location: Piscataway Americas, United States
Employment Type: -
Job Description:

Omnyx’s vision is to transform the scope of pathology through leveraging medical imaging research and developing a novel, ground-breaking and fully digital pathology solution. At Omnyx you will make a difference in healthcare and apply every ounce of your experience to design, build and market solutions that break through the current limitations in pathology. Our products improve patient care by increasing pathologists’ productivity, efficiency, as well as patient safety. We offer an entrepreneurial atmosphere with rich opportunities for self-directed people to thrive and grow professionally.

At Omnyx, we embrace a highly collaborative culture, working very closely with our partners and luminaries to fully understand and embrace the customers’ needs. Together we will deliver the best digital pathology products available. We are a high-tech startup with solid financial backing and support from GE Healthcare and University of Pittsburgh Medical Center. Recently covered by CNBC, Bloomberg, and PBS Nightly Business along with a host of print media Omnyx is the company to watch as the digital pathology market takes shape.

Essential Functions (Responsibilities):

The successful candidate will join the Omnyx Scanner Hardware reporting directly to the VP of Instrument Research and Development and will work both independently and closely with other senior leadership team members to perform general development tasks such as Risk Assessment, Requirements Management, Design Verification and Change Control for a medical device including:
-Facilitating risk assessments including process, functional and component FMEAs.
-DOORS administration, managing requirements and traceability through the development lifecycle.
-Taking responsibility, including strategy, aiding in execution and documentation for verification plans, procedures and test reports.
-Taking responsibility for supporting engineering change process.
-Performing risk assessment and test impact analysis.
-Project management support including defining project schedules and milestones. Qualifications/Requirements Qualifications:
-BS in Biomedical, Electrical, Mechanical Engineering or Systems Engineering
-7+ years overall engineering experience in an interdisciplinary product environment.
-2+ years experience in a SE role while operating in an FDA regulated environment
-Experience in program planning, e.g. developing work breakdown structures, resource planning, program risk management
-Experience in project management or task leadership
-Experience with requirements management; from development through verification and validation
-Experience with requirements management tools
-Experience in facilitating safety risk management activities, e.g. process and design FMEAs
-Experience with the development of product/system architectures
-Experience with safety compliance process (product safety marks)
-Experience with Design Verification activities
-Experience with Design Validation activities
-Working knowledge of applicable EU New Approach Directives, e.g. MDD, IVDD
-Working knowledge of regulatory submissions, e.g. FDA 510(k), CE Marketing
-Strong interpersonal and communication skills are required as this position will entail direct engagement with external contractors, project team, vendors and compliance agencies.
-Ability to work effectively in a multi-disciplinary environment
-Outstanding problem solving skills
-Ability to present ideas and results effectively Additional Eligibility Qualifications GE will only employ those who are legally authorized to work. Any offer of employment is conditioned upon the successful completion of a background investigation and drug screen. Desired Characteristics Desired:
-MS in Biomedical, Electrical, Mechanical Engineering or Systems Engineering
-Experience in developing IVD devices
-Experience in developing medical imaging/radiology devices
-Experience in developing cellular or histological imaging devices
-Working knowledge with Software Development for a Class II Medical Device
-Experience in small start-up environment-
-Experience in large multinational medical device companies
-Six sigma certification
-Formal leadership or project management training
Job Ref No: 1155157