Contract Systems Engineer – Assay Development
Schedule: Monday–Friday, 8:00 AM–5:00 PM
Work Model: Hybrid (minimum 3 days on-site)
Experience Level: 3–5 years
About the Role
Join a collaborative R&D team as a Systems Engineer – Assay Development, where you'll take the lead on requirements definition, risk management, and verification and validation (V&V) activities for innovative diagnostic products. You’ll help shape system architecture, ensure compliance with IVD standards, and drive project deliverables forward through thoughtful decisions and balanced tradeoffs.
This role is perfect for an engineer who enjoys working cross-functionally and wants to see their contributions directly impact high-quality diagnostic solutions.
Key Responsibilities
- Define clear, traceable system requirements and develop system architecture for diagnostic products.
- Own and manage project deliverables, guiding teams through decision-making and tradeoff analysis.
- Lead and execute risk management activities, including FMEA, to ensure safety and compliance within regulated environments.
- Develop and support verification and validation (V&V) strategies to meet IVD standards.
- Collaborate across engineering, assay development, quality, and regulatory teams to align requirements and project goals.
- Apply systems engineering principles including configuration management, requirements traceability, risk assessment, and system integration.
Must-Have Qualifications
- Bachelor’s degree in Engineering (required).
- 3–5 years of experience in a regulated industry (medical device field strongly preferred).
- Hands-on experience writing system requirements in a regulated environment.
- Proven experience conducting risk analysis (FMEA) in an engineering discipline.
- Strong understanding of systems engineering principles—especially requirements engineering, tradeoff analysis, risk management, configuration management, and V&V practices.
- Ability to collaborate with multiple stakeholders and drive alignment while balancing competing priorities.
Preferred / Ideal Experience
- Assay development experience, especially involving cytology specimens.
- Familiarity with tools such as RETINA (Requirements & Test Integration Application), LucidSpark, or LucidChart.
- Excellent organizational skills, with the ability to manage multiple tasks, evaluate priorities, and meet deadlines.
What Success Looks Like in This Role
- You take full ownership of your project deliverables and contribute proactively to team discussions and decisions.
- You bridge communication across departments, ensuring requirements are understood, risks are managed, and solutions are aligned with overall system goals.
- You apply disciplined engineering practices to support safe, effective, and compliant diagnostic system development.
This role offers the opportunity to contribute directly to impactful healthcare innovations while developing expertise in systems engineering within assay development. If you are detail-driven, collaborative, and passionate about solving complex engineering challenges, this is a great fit.
#WCH
Job Types: Full-time, Contract
Pay: $45.00 per hour
Expected hours: 40 per week
Benefits:
- 401(k)
- Dental insurance
- Health insurance
- Life insurance
- Vision insurance
Work Location: In person
