What are the responsibilities and job description for the Systems Engineering Design Leader position at Pentangle Tech Services | P5 Group?
Responsibilities: Duties include (but are not limited to):
Lead the definition of incremental features (ex: essential characteristics, accessories, alarms, etc.) for our new SEALM (Systems Eng Application Lifecycle Management) tool, specifically Jama Connect.
As part of feature development in SEALM, lead the following activities:
Gather initial stakeholder inputs and existing best practice implementations across key product teams
Define a draft “standard work” proposal (process definition, training package, and proposed tool configuration including formal change requests). Refer to applicable GEHC internal standards, work instructions, and external standards for guidance
Identify “corner case” subset of users and verify that the standard work or process proposal meets their needs. Use this as the initial “MVP” proposal
Communicate to the broad community of all users the new standard process or work
Triage feedback received from the community into 1) Must fix, gates adoption, 2) Productivity improvement (to be planned), 3) Nice to have…probably the team needs to migrate to new standard work.
Submit formal change requests for implementation and ‘shepherd’ through deployment
Create a summary explaining the triage (when we enforce standard work, when do we accept local practices as appropriate “tailoring”)
Create and deploy training in each feature
After initial deployment, monitor user requests for enhancements, and iterate steps 5 to 8 above for each request
Work with SEALM design lead to identify cluster of features that have similar implementations. Develop an explanation of how the cluster of features works
Some features depend on the specific country list in scope (languages and regulations are required for that country). Ability to work with the design team to understand how the country scope flows into the program and the SEALM tool
Qualifications/Requirements
1. Bachelor of Science Degree in Engineering or closely related field
2. Minimum 7 years of Systems engineering work experience
3. Minimum 3 years of experience working in ALM tools (ex: Jama, DOORS, etc.)
4. Minimum 3 years of product development work experience in design engineering
5. Demonstrated ability to work within a cross-functional, global project team
6. Familiarity with industry design, regulatory, and safety standards
Desired Qualifications
1. Master of Science Degree in Engineering or closely related field
2. Demonstrated 10 years of work experience in design, product development of medical devices
3. Demonstrated knowledge of med device regulatory, safety standards including ISO, FDA, and IEC60601 series
4. Experience leveraging external organizations and university resources
5. Ability to interpret, extract key elements and explain complex technical information
6. Demonstrated experience and ability to influence and teach technical subject matter around Systems Engineering