Location: Hybrid
Overview
We are seeking a motivated Systems Engineer to join our R&D team, with a focus on requirements, risk management, and software integration/testing. In this role, you’ll play a critical part in advancing diagnostic solutions by driving system-level design, integration, and validation practices that meet regulatory and customer needs. This is a hybrid position offering the opportunity to collaborate across multiple functions in a dynamic, innovative environment.
Key Responsibilities
- Systems Engineering Lifecycle: Apply broad systems engineering principles with an emphasis on software integration and testing throughout the product lifecycle.
- Requirements & Risk: Define, manage, and trace software requirements, ensuring risk analysis, tradeoffs, and mitigation strategies are clearly documented and executed.
- Industry & Technology Analysis: Stay informed on industry trends, competitive technologies, and emerging innovations to identify opportunities for differentiation and creative solutions.
- Cross-Functional Collaboration: Partner with R&D, Marketing, Operations, Quality, and Regulatory teams to ensure solutions align with organizational goals and compliance standards.
- Customer-Centered Innovation: Work closely with business stakeholders and customer representatives to prioritize software features and ensure solutions meet market demands.
- Problem Solving: Investigate technical challenges, propose alternative solutions, and support decision-making with clear tradeoff analyses.
- Project Delivery: Execute deliverables related to requirements, risk management, configuration management, defect tracking, and verification/validation using company tools.
Qualifications
- Education:
- Bachelor’s degree in Engineering, Biomedical Sciences, or a related technical field with 4+ years of experience; OR
- Master’s degree with 2+ years of experience; OR
- PhD with relevant background.
- Experience & Skills:
- Strong knowledge of systems engineering principles, specifically in software integration and testing.
- Hands-on experience in requirements engineering, tradeoff analysis, risk management, configuration management, and verification/validation.
- Familiarity with regulated environments and FDA, ISO, or related diagnostic standards.
- Ability to analyze complex technical issues, present solution options, and guide teams in making informed decisions.
- Interest in emerging technologies and awareness of the competitive diagnostic landscape.
Preferred Qualifications
- Deep knowledge in software reliability, manufacturability, and usability.
- Strong leadership and communication skills, with the ability to foster accountability across teams.
- Excellent organizational abilities, capable of managing multiple projects and priorities effectively.
- Experience with assay development processes.
- Proficiency with tools such as RETINA (Requirements & Test Integration Application), LucidSpark, and LucidChart.
- Advanced understanding of software engineering, electronics, electro-mechanical systems, IT, and basic chemistry.
What We’re Looking For
The ideal candidate is a systems thinker with strong technical depth and a collaborative mindset. You should bring proven expertise in software integration/testing within a regulated environment and demonstrate the ability to balance innovation with compliance. A strategic perspective, strong communication skills, and a passion for improving diagnostic solutions will set you apart.
#WCH
Job Types: Full-time, Contract
Pay: $39.00 per hour
Expected hours: 40 per week
Benefits:
- 401(k)
- Dental insurance
- Health insurance
- Vision insurance
Education:
Experience:
- Software testing: 1 year (Required)
- Requirements analysis: 1 year (Required)
- Regulated Environment: 1 year (Required)
- firmware Integration: 1 year (Required)
Work Location: In person
