Job Description

Hiring: Systems Engineer – Assay Development

Location: Oro Valley, AZ, 85755 (Hybrid)

Duration: 10 Month Contract

About the Role

We are seeking an experienced Systems Engineer – Assay Development to join our R&D team on a contract basis. In this role, you will play a critical part in driving requirements definition, risk management, and verification and validation (V&V) activities across complex projects within a regulated medical device environment. You will take ownership of key deliverables, contribute to system architecture decisions, and facilitate cross-functional alignment to ensure compliance with IVD standards.

Key Responsibilities

• Lead requirements definition, documentation, and management in accordance with regulated medical device standards
• Drive system-level risk management activities, including FMEA and tradeoff analyses
• Support system architecture design and ensure traceability across requirements, risks, and verification activities
• Plan and execute verification and validation strategies to ensure compliance and product quality
• Collaborate cross-functionally with R&D, quality, regulatory, and other stakeholders to balance competing needs and priorities
• Own assigned project deliverables and support data-driven decision-making processes

Required Skills

• Bachelor’s degree in Engineering (required)
• Proven experience writing requirements in a regulated industry (medical device experience strongly preferred)
• Hands-on experience performing risk analysis (e.g., FMEA) in an engineering discipline
• Strong knowledge of systems engineering principles, including: Requirements engineering, Risk management, Tradeoff analysis, Configuration management, Verification and validation
• Demonstrated ability to work cross-functionally and align diverse stakeholder requirements

Highly Preferred:

• Assay development experience, particularly with cytology specimens
• Prior experience using RETINA (Requirements & Test Integration Application)
• Familiarity with LucidSpark and/or LucidChart
• Strong organizational skills with the ability to manage multiple priorities and projects effectively

Why Join Us

• Opportunity to work on impactful R&D projects within a regulated medical device environment
• Collaborative, cross-functional team culture
• Contract role offering exposure to advanced systems engineering and assay development initiatives

#assaydevelopment #LucidSpark #LucidChart #RETINA #FMEA #pharma #pharmaceutical #lifescience #medicaldevice

Job Tags

Similar Jobs