Position Summary:

Using Engineering procedures standard for research and development, carries out assignments associated with research, design, development, support or manufacturing of specific parts, processes, software or components of medical diagnostic systems.  Independently evaluates, selects, and applies standard engineering techniques, procedures, and criteria, using judgment in making minor adaptations and modifications.  Under the general direction of a functional manager, with moderate latitude for self-direction, operates in one or more areas of responsibility within a specific function.

This role will be the lead Systems Engineer for new product development of a GEM Premier instrument, which is a whole blood diagnostic instrument for measuring pH, blood gases, electrolytes, metabolites, and more. The architecture of a GEM Premier instrument is being refreshed to address obsolescence and modernize the user experience. Systems Engineering is the functional group within R&D Hardware Engineering that is responsible for integrating hardware into full systems with software and firmware. Major areas of focus are unit integration, configuration management, requirements engineering, risk management, and verification.

Research, design, develop, and support manufacturing of specific parts, processes, software or components of medical diagnostic systems. Independently evaluate, select, and apply standard engineering techniques, procedures, and criteria, using judgment in making adaptations and modifications.

Key Accountabilities

Essential Functions:

• Acts as a technical lead for a specific project.
• Accountable for the completion of assigned deliverables in accordance with approved schedules.
• Authors documentation and participates in activities in support of design control
• Independently plans, performs & prioritizes tasks that are moderately complex in nature, in alignment with corporate goals.
• Analyzes and interprets data, identifying trends and formulating the next steps, if required by the function.
• Integrates hardware with software/firmware components
• Leads development of product requirements and risks, including but not limited to:
• System and subsystem requirements
• Subsystem specifications
• Design and User Failure Mode Effects & Critical Analysis (d/uFMECAs or d/uFMEAs)
• Traceability matrices
• Design change risk assessments
• User needs, human factors, usability
• Leads product verification through protocols/execution/reports
• Characterizes product reliability at both the system and subsystem levels
• Identifies product defects and recognizes outliers in results. Can explain and document product defects and their impact.
• Effectively communicates complex technical information to a cross-functional team in the form of documentation, presentations, and technical summaries.
• Technical expertise in complex electromechanical devices
• Provides technical guidance to and/or supervision of other group members and cross-functional technical teams. Able to mentor others.
• Provides technical support for or leads investigations in support of development and/or on-market activities.
• Independently generates predictable schedules for activities related to assigned projects.
• Oversees hardware development performed by an external consultant

Secondary Functions:

• May review and provide input to deliverables from other functions.
• Recommends and implements improvement initiatives to aid department practices.

Budget Managed: (if applicable)

• N/A

Internal Networking/Key Relationships

To be determined based on department needs, to include interactions such as:

• Will interface on a regular basis with groups across the organization as needed

Skills & Capabilities:

The ideal candidate for this position will exhibit the following skills and capabilities:

• Statistical Analysis (if required by the function), Root Cause Analysis, Creative Problem Solving, Critical Thinking
• Technically adept and confident
• Leadership: Accountability, Decision Making, Influence, Communication
• Mentoring
• Product development of complex electromechanical devices

Minimum Knowledge & Experience Required for the Position:

Education:

• Bachelor's degree in Engineering, Science or a related field

Experience:

• Eight years of product development or relevant experience
• Four to six years of product development or relevant experience for advanced degrees
• For internal candidate promotion: Demonstrated proficiency in meeting all competencies of current level and acceptable performance history may be used in lieu of experience
• In vitro medical device experience highly desired.

Additional Skills/Knowledge:

• Language: Proficiency in English language required

International Mobility:

• Required: No

Travel Requirements:

• Some domestic and international travel may be required.