Senior Medical Device Systems Engineer (FDA/ISO Regs)

Planet Pharma; Tucson (AZ); On-site; USD 69,000 - 83,000; Full time

Job summary

Planet Pharma seeks a systems engineer to deliver V-Model outputs, conduct development and testing, and ensure assays operate using the latest technologies. You will translate regulations into testable requirements, create and manage test plans, and author comprehensive technical reports while handling defect lifecycles.

Requirements include a Bachelor's in Engineering and 8 years' experience in FDA/FAA regulated environments; strong emphasis on traceability and compliance, with hands-on testing

Qualifications

• Experience translating industry standards, government regulations, and stakeholder mandates into clear, testable engineering requirements.
• Ability to read, interpret, and trace regulations (ISO, IEC, FDA, EU) without losing intent.
• Experience extracting functional, performance, interface, and constraint requirements from dense regulatory text.
• Ability to break down high-level compliance statements into hardware, software and system requirements.
• Establishing bidirectional traceability linking source regulations to system requirements, design specs and tests.

Responsibilities

• TMV, Test Method Development, DoE, data analysis (python coding capability)
• Digital outputs of a sensor and analyze the data
• Test bed development
• Troubleshooting skills
• Developing comprehensive testing plans
• Executing hands-on testing protocols
• Authoring detailed technical reports
• Managing the defect lifecycle (collection, documentation, and summarization for our development partner)

Skills

Regulatory requirements translation

Regulatory interpretation

Requirements extraction from text

Requirements decomposition

Traceability management

Education

Bachelor's degree in Engineering

Tools

RETINA

DOORS

Jira

Job description

Planet Pharma seeks a systems engineer to deliver V-Model outputs, conduct development and testing, and ensure assays operate using the latest technologies. You will translate regulations into testable requirements, create and manage test plans, and author comprehensive technical reports while handling defect lifecycles.

Requirements include a Bachelor's in Engineering and 8 years' experience in FDA/FAA regulated environments; strong emphasis on traceability and compliance, with hands-on testing