Systems Engineer - Assay Development

Job Title: Systems Engineer – Assay Development

Location: Oro Valley, AZ 85755
Duration: 11 Months Contract
Work Type: Onsite

Job Summary

We are seeking an experienced Systems Engineer – Assay Development to join our R&D team. In this role, you will drive requirements definition, risk management, and verification and validation activities across regulated medical device development projects. The ideal candidate will have strong systems engineering expertise, experience working in regulated environments, and the ability to collaborate cross-functionally to deliver high-quality IVD solutions.

Key Responsibilities

• Define, document, and manage system and subsystem requirements in compliance with medical device regulations

• Lead systems engineering activities including requirements engineering, tradeoff analysis, risk management, and configuration management

• Perform and maintain risk analyses (FMEA) throughout the product lifecycle

• Support system architecture design and ensure alignment with project and regulatory requirements

• Plan and support verification and validation (V&V) activities to ensure requirements are met

• Collaborate with cross-functional teams including R&D, Quality, Regulatory, and Manufacturing

• Take ownership of assigned deliverables and support informed decision-making through data-driven tradeoff analysis

• Maintain clear documentation and traceability using requirements and test management tools

Required Qualifications (Must Have)

• Bachelor’s degree in Engineering or related field

• Hands-on experience writing requirements in a regulated industry (medical device industry preferred)

• Experience conducting risk analysis (FMEA) in an engineering discipline

• Strong knowledge of systems engineering principles, including:

  • Requirements engineering

  • Risk management

  • Tradeoff analysis

  • Configuration management

  • Verification and validation (V&V)

• Proven ability to work cross-functionally with multiple stakeholders and balance competing priorities

Preferred Qualifications (Nice to Have)

• Assay development experience, especially with cytology specimens

• Prior experience with RETINA (Requirements & Test Integration Application)

• Familiarity with LucidSpark and LucidChart

• Excellent organizational and prioritization skills with the ability to manage multiple projects

You will receive the following benefits:

• Medical Insurance - Four medical plans to choose from for you and your family
• Dental & Orthodontia Benefits
• Vision Benefits
• Health Savings Account (HSA)
• Health and Dependent Care Flexible Spending Accounts
• Voluntary Life Insurance, Long-Term & Short-Term Disability Insurance
• Hospital Indemnity Insurance
• 401(k) including match with pre and post-tax options
• Paid Sick Time Leave
• Legal and Identity Protection Plans
• Pre-tax Commuter Benefit
• 529 College Saver Plan

Motion Recruitment Partners (MRP) is an Equal Opportunity Employer. All applicants must be currently authorized to work on a full-time basis in the country for which they are applying, and no sponsorship is currently available. Employment is subject to the successful completion of a pre-employment screening. Accommodation will be provided in all parts of the hiring process as required under MRP’s Employment Accommodation policy. Applicants need to make their needs known in advance.