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Senior Systems Engineer
| Company | Werfen |
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| Location | San Diego, CA, USA |
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| Salary | $110000 – $150000 |
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| Type | Full-Time |
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| Degrees | Bachelor’s |
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| Experience Level | Senior, Expert or higher |
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Requirements
- Bachelor’s degree in Systems Engineering, Bioengineering, Mechanical Engineering, or a related field
- 6-10 years of relevant experience in systems engineering, biotech, or medical device development
- Prior knowledge of System Development Lifecycle (SDLC) concepts and best practices
- Ability to read and interpret the established Werfen procedures
- Ability to elicit, create, and manage requirements / Design Inputs from various sources
- Ability to create system flow documents from the ground-up
- Ability to lead, influence, and motivate people without direct authority
- Excellent written and verbal communication skills for cross-functional collaboration
- Strong analytical and problem-solving skills, including root cause analysis
- Proficiency in Microsoft Office Suite (Excel, Word, PowerPoint)
Responsibilities
- Supports multiple medium- to large-sized projects associated with the development of new diagnostic instruments or improvements to existing in-vitro diagnostic instruments
- Communicates project status, risks, and technical challenges to team leads and management
- Responsible for defining, documenting, and managing system and software requirements for a project
- Develops system flow diagrams, architecture documentation, and interface specifications to support system design and integration
- Participates in and/or performs system integration testing, verification, and validation activities
- Plans, executes, and analyzes verification and validation (V&V) activities
- Supports troubleshooting activities, failure investigations, and risk assessments
- Utilizes data analytics and modeling techniques to optimize system performance
- Ensures compliance and risk management standards
- Responsible for maintaining the Design History File (DHF) for system, instrument, and software development projects
- Participates in technical reviews and evaluations to ensure robust system design and risk mitigation
- Works closely with Software, Hardware, Assay Development, Quality, and Manufacturing teams
- Provides input on and reviews user manuals, system specifications, and process improvements
- Mentors junior engineers and provides technical guidance to project teams
- Leads technical reviews and supports project planning activities
Preferred Qualifications
- Master’s degree is a plus
- Six-sigma certification preferred
- Statistical analysis skill preferred (DOE, regression analysis, capability studies)
- Experience in a regulated environment (FDA, ISO 13485, IEC 60601-1)
