Systems Engineer - Risk

this opportunity is not open to c2c relationships or visa sponsorship.

this position is open to out of state candidates but they must relocate themselves to the tucson, az area. No relocation assistance will be provided.

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.

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

• 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

• 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
• 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.

preferred:

• specialized skills: deep knowledge in reliability, manufacturability, and usability.
• leadership and communication: proven ability to build authority and accountability within a team, with strong collaboration and communication skills.
• organizational skills: excellent organizational skills, capable of evaluating, prioritizing, and