Senior Engineer
Senior Engineer
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Job Description
Overview
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 selfdirection operates in one or more areas of responsibility within a specific function.
Responsibilities
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//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 crossfunctional 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 crossfunctional technical teams. Able to mentor others.
- Provides technical support for or leads investigations in support of development and/or onmarket 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
Qualifications
Minimum Knowledge & Experience Required for the Position:
Education:
- Bachelors degree in Engineering Science or a related field
Experience:
- Ten years of product development or relevant experience
- Six to eight 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.
Required Experience:
Senior IC
Employment Type
Full-Time
