Biomedical Systems Engineer

TalentBurst, an Inc 5000 company; Tucson (AZ); On-site; USD 90,000 - 120,000; Full time

Job summary

A leading diagnostics firm in Tucson is looking for a Systems Engineer to join their team. This onsite position focuses on advancing cancer diagnostics through the development of state-of-the-art testing automation. Candidates are required to possess a Bachelor's degree in Engineering or Biomedical Sciences along with relevant experience in systems engineering within a regulated medical device environment. The role involves responsibility for product definitions, requirements management, and cross-functional collaboration to align solutions with customer needs.

Qualifications

• Bachelor's degree in Engineering or Biomedical Sciences with 4 years of experience.
• Knowledge of systems and hardware integration and testing.
• Experience in a regulated medical device industry.

Responsibilities

• Apply Systems Engineering to product definition and verification.
• Manage requirements, risk analysis, and testing.
• Collaborate with R&D, Marketing, and Regulatory teams.
• Work with R&D, Marketing, Operations, Quality, and Regulatory teams to ensure alignment.
• Engage with leaders and VoC representatives to align solutions with customer needs.

Skills

Systems Engineering

Requirements Engineering

Risk Management

Regulatory Standards (FDA, ISO)

Cross-functional Collaboration

Medical device

Education

Bachelor's degree in Engineering or Biomedical Sciences

Master's degree with 2 years experience or PhD

PhD (considered)

Tools

RETINA

Job description

Location

Tucson, AZ (100% onsite only)

Duration

18+ Months Contract

Job Description

This is an onsite position for a motivated, hands‑on engineer who has experience with electro‑mechanical devices.

Position

Tissue Diagnostics is seeking a Systems Engineer to drive product definition, including requirements, system architecture design, risk analysis, and solution implementation to meet IVD standards. This role focuses on advancing cancer diagnostics through state‑of‑the‑art testing automation, providing over 250 cancer tests and associated instruments globally.

Education & Experience required

• Educational Background: Bachelor's degree in Engineering, Biomedical Sciences, or related technical field with 4 years of experience (or Master's with 2 years, or PhD).
• Systems Engineering Expertise: Demonstrated knowledge in systems and hardware integration and testing, including requirements engineering, tradeoff analysis, risk management, and verification/validation using tools like RETINA
• Regulatory Familiarity: Experience in a regulated environment, familiar with FDA, ISO, and other relevant diagnostic product standards.
• Strategic Mindset: Interest in innovative technologies and understanding of the IVD competitive landscape.
• Experience in front‑end Systems Engineering design & development deliverables around requirements, risks & architecture.
• Ability to work independently and cross‑functionally with many different groups to solicit needs and complete trade off analyses
• Experience in a regulated medical device industry

Responsibilities

• System Lifecycle Management: Apply Systems Engineering to product definition, requirements, risk analysis, and testing.
• Project Execution: Manage requirements, risk analysis, and verification/validation.
• Industry and Technology Analysis: Research trends, emerging technologies, and competitive products' differentiation.
• Cross‑functional Collaboration: Work with R&D, Marketing, Operations, Quality, and Regulatory teams to ensure alignment.
• Customer‑Focused Innovation: Engage with business leaders and VoC representatives to align technical solutions with customer needs.
• Technical Problem Solving: Analyze complex technical challenges, present solutions, and facilitate informed decision‑making.