Systems Engineering Design Leader

Continuous Improvement Engineer – Plastic Packaging – Wisconsin

Responsibilities:

• 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 activities including gathering initial stakeholder inputs and existing best practice implementations across key product teams; defining a draft “standard work” proposal (process definition, training package, and proposed tool configuration including formal change requests); referring to applicable GEHC internal standards, work instructions, and external standards for guidance; identifying a “corner case” subset of users and verifying the proposal meets their needs;
  
  communicating the new standard process or work to the broad community of all users.
• Triage feedback received from the community into categories such as must fix, gates adoption, productivity improvement, and nice‑to‑have; submit formal change requests for implementation and shepherd through deployment.
• Create a summary explaining the triage and when to enforce standard work versus acceptable local practices.
• Create and deploy training for each feature.
• After initial deployment, monitor user requests for enhancements and iterate the above steps for each request.
• Work with the SEALM design lead to identify clusters of features with similar implementations and develop explanations of how each cluster works.
• Some features depend on the specific country list in scope (languages and regulations); collaborate with the design team to understand how the country scope flows into the program and the SEALM tool.

• Bachelor of Science Degree in Engineering or closely related field.
• Minimum 7 years of Systems engineering work experience.
• Minimum 3 years of experience working in ALM tools (ex: Jama, DOORS, etc.).
• Minimum 3 years of product development work experience in design engineering.
• Demonstrated ability to work within a cross‑functional, global project team.
• Familiarity with industry design, regulatory, and safety standards.

• Master of Science Degree in Engineering or closely related field.
• Demonstrated 10+ years of work experience in design and product development of medical devices.
• Demonstrated knowledge of medical device regulatory and safety standards including ISO, FDA, and IEC
  60601 series.
• Experience leveraging external organizations and university resources.
• Ability to interpret, extract key elements, and explain complex technical information.
• Demonstrated experience and ability to influence and teach technical subject matter around Systems Engineering.

• Mid‑Senior level

• Contract