Sr. Systems Engineer (hardware) Job Posting
| Job Title: |
Sr. Systems Engineer (hardware)
|
| Company: | Omnyx |
| Position Type: | Permanent |
| Pay Rate: | tbd |
| Skills: |
Systems Engineer
|
| Date Posted: | Jun-08-12 |
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Essential Functions (Responsibilities):
The successful candidate will join the Omnyx Scanner Hardware reporting directly to the R&D Hardware Manager and will work both independently and closely with other project manager and project team members to perform general development tasks such as Risk Assessment, Requirements Management, Design Verification and Change Control for a medical device including:
Defining system and subsystem specifications, establishing traceability between system and subsystem level specifications and associated verification protocols
System and subsystem design including defining architecture, theory of operation and interface specifications, performing trade-off analysis and documenting the design in design documents.
Taking responsibility, including strategy, aiding in execution and documentation for verification plans, procedures and test reports.
Performing risk assessment including process, functional and component FMEAs and establishing traceability
Taking responsibility for supporting engineering change process including performing change impact analysis,
Taking responsibility for managing defects including working with the design team to conduct root cause analysis and ensuring that defects are resolved and verified
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 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
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
Desired:
MS in Biomedical, Electrical, Mechanical Engineering or Systems Engineering
Experience in developing IVD devices
Experience in developing cellular or histological imaging devices
Working knowledge with Software Development for a Class II Medical Device
The successful candidate will join the Omnyx Scanner Hardware reporting directly to the R&D Hardware Manager and will work both independently and closely with other project manager and project team members to perform general development tasks such as Risk Assessment, Requirements Management, Design Verification and Change Control for a medical device including:
Defining system and subsystem specifications, establishing traceability between system and subsystem level specifications and associated verification protocols
System and subsystem design including defining architecture, theory of operation and interface specifications, performing trade-off analysis and documenting the design in design documents.
Taking responsibility, including strategy, aiding in execution and documentation for verification plans, procedures and test reports.
Performing risk assessment including process, functional and component FMEAs and establishing traceability
Taking responsibility for supporting engineering change process including performing change impact analysis,
Taking responsibility for managing defects including working with the design team to conduct root cause analysis and ensuring that defects are resolved and verified
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 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
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
Desired:
MS in Biomedical, Electrical, Mechanical Engineering or Systems Engineering
Experience in developing IVD devices
Experience in developing cellular or histological imaging devices
Working knowledge with Software Development for a Class II Medical Device
| Location: | US-PA-Pittsburgh |
| Telecommute: | No (Onsite Position) |
| Contact Name: | Hemanti Bhatia |
| Contact Phone: | 412 894 2096 |
| Contact Email: | hemanti.bhatia@omnyx.com |
| URL: | http://omnyx.theresumator.com/apply/EpaVPw/Sr-Systems-Engineer-Hardware.html |
|
Please mention Dev Bistro when contacting us. |
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