Systems Engineer

Aquent has an exciting opportunity for a Systems Engineer in Tucson, AZ!

This is a hybrid position. For this reason, we will only consider candidates who currently live in the Tucson, AZ area and can comfortably commute to our client's office.

In addition, to be considered for this position, you must:

• Be authorized to work in the United States
• Not require sponsorship of any kind for the duration of the assignment
• Be able to work on a W-2 basis. C2C or 1099 is not permitted for this position

Are you ready to shape the future of healthcare diagnostics and make a tangible impact on patient lives? As a vital partner to a global leader in diagnostic innovation, Aquent is seeking a visionary professional to drive critical system development, ensuring cutting-edge solutions reach those who need them most. Your expertise will directly influence the precision and reliability of next-generation diagnostic tools, contributing to a healthier future for all.

Our client is a global leader in healthcare innovation, dedicated to advancing science and ensuring access to essential healthcare. They are at the forefront of diagnostic solutions, revolutionizing testing automation and empowering healthcare professionals with high-quality, innovative systems. Their commitment to excellence and constant innovation drives the discovery, development, and delivery of advanced diagnostic systems, ultimately improving patient outcomes and quality of life.

We are seeking a dynamic individual to join their R&D team and play a pivotal role in the entire system lifecycle. This is an extraordinary opportunity to drive the definition of requirements, meticulous risk management, and robust verification and validation practices for groundbreaking projects. You will be instrumental in designing system architectures and implementing solutions that meet stringent industry standards, taking ownership of critical deliverables and facilitating informed decision-making that balances innovation with practicality.

**What You'll Do:**

* System Lifecycle Leadership: Apply your comprehensive knowledge of Systems Engineering principles, with a keen focus on requirements engineering, risk management, and verification & validation throughout the system lifecycle.

* Strategic Analysis: Research and analyze industry trends, emerging technologies, and competitive landscapes to identify opportunities for robust requirements, proactive risk mitigation, and highly effective validation strategies.

* Cross-functional Collaboration: Partner closely with R&D, Marketing, Operations, Quality, and Regulatory teams to ensure seamless alignment with organizational objectives and regulatory requirements, emphasizing traceability, risk assessment, and validation.

* Customer-Centric Innovation: Engage with business leaders and customer representatives to ensure technical solutions are perfectly aligned with user needs and market demands, facilitating stakeholder discussions to prioritize requirements, assess associated risks, and define appropriate validation criteria.

* Complex Problem Solving: Analyze intricate technical challenges, propose multiple innovative solution paths, and guide stakeholders in making well-informed decisions, offering clear options for requirements definition, risk mitigation, and verification & validation.

* Project Execution Excellence: Execute project deliverables related to requirements engineering, risk analysis, configuration management, defect management, and verification & validation within established company tools.

**Must-Have Qualifications:**

* Bachelor's degree in Engineering, Biomedical Sciences, or a related technical field with 4 years of experience; or a Master's degree with 2 years of experience; or a PhD.

* Proven experience in assay development within a medical device company.

* Demonstrated expertise in systems engineering principles, including requirements engineering, tradeoff analysis, risk management, configuration management, and verification and validation.

* Experience working in a regulated environment, with familiarity with relevant regulatory standards for diagnostic products, particularly concerning requirements, risk, and validation.

* A strategic mindset with a keen interest in innovative technologies and a solid understanding of the competitive landscape in diagnostics, allowing you to identify potential risks, critical requirements, and robust validation approaches.

**Nice-to-Have Qualifications:**

* Knowledge of specialized assay development in a clinical workflow setting, including familiarity with various related techniques and their applications.

* Deep knowledge in requirements elicitation, risk analysis methodologies (e.g., FMEA), usability engineering, and V&V test strategy development.

* Proven ability to build authority and accountability within a team, coupled with strong collaboration and communication skills, especially in facilitating discussions around complex requirements, risks, and validation plans.

* Excellent organizational skills, with the ability to efficiently evaluate, prioritize, and manage multiple projects; capable of formulating and solving problems, and completing work in a timely, accurate, and thorough manner, particularly in managing extensive requirement sets, risk registers, and verification & validation matrices.

* Advanced understanding of software engineering, electronics, electro-mechanical systems, information technology, and basic chemistry, to enhance the definition of requirements, assessment of risks, and planning of validation across system components.

* Experience with requirements and test integration applications and visual collaboration tools.

The target hiring compensation range for this role is $35.10 to $39.00 an hour. Compensation is based on several factors including, but not limited to education, relevant work experience, relevant certifications, and location.

**About Aquent Talent:**

Aquent Talent connects the best talent in marketing, creative, and design with the world's biggest brands.

Our eligible talent get access to amazing benefits like subsidized health, vision, and dental plans, paid sick leave, and retirement plans with a match. More information on our awesome benefits!

Aquent is an equal-opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, and other legally protected characteristics. We're about creating an inclusive environment-one where different backgrounds, experiences, and perspectives are valued, and everyone can contribute, grow their careers, and thrive.

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