Systems Engineer
9 days ago
Tucson
Job Description Position: Systems Engineer, Req#: ROCGJP00039188 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. The 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. #TB_EN #ZR depending on experience ** Required Skills/Experience: Job Description: **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 The 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. 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. Who You Are: --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 managing multiple projects efficiently.Company DescriptionFounded in 2002 by three former Monster.com executives; TalentBurst is an award-winning full-service Staffing Firm working directly with Fortune 500 companies in the US and Canada. We specialize in Contract and Contract to Permanent roles across many industries and have direct/contractual relationships with all our clients. Please visit our website or come meet us at our offices in Natick, MA, Miami, FL, Christiansburg, VA, Vineland, NJ, Houston, TX & downtown San Francisco, CAFounded in 2002 by three former Monster.com executives; TalentBurst is an award-winning full-service Staffing Firm working directly with Fortune 500 companies in the US and Canada. We specialize in Contract and Contract to Permanent roles across many industries and have direct/contractual relationships with all our clients. Please visit our website or come meet us at our offices in Natick, MA, Miami, FL, Christiansburg, VA, Vineland, NJ, Houston, TX & downtown San Francisco, CA