Systems Engineer - Assay Development

M-F, 8am to 5pm

--Hybrid (Minimum 3 days in office)

--3-5 years of experience

As a member of our R&D team, the Systems Engineer will drive requirements definition, risk management, and verification & validation practices in projects. This includes defining requirements, designing system architectures, and implementing solutions to meet IVD standards. This individual will take ownership of project deliverables and facilitate the decision-making process with well-considered tradeoffs.

Skill Set Requirements

MUST HAVE:

--Requirement writing experience in a regulated industry (medical device industry preferred)

--Risk analysis (FMEA) work in an engineering discipline (regulated medical device company preferred)

--Demonstrated knowledge of systems engineering principles, specifically in requirements engineering, tradeoff analysis, risk management, configuration management, and verification and validation.

--Ability to work cross-functionally with many stakeholders, weighing the needs of many stakeholders and coming to an alignment balancing all needs and tradeoffs

IDEAL

--Assay development experience - particularly with cytology specimens

--Prior experience in RETINA (Requirements & Test Integration Application) and with LucidSpark/LucidChart.

--Excellent organizational skills, with the ability to efficiently evaluate, prioritize, and handle multiple projects and priorities

Bachelor's degree in Engineering is required

Pay ranges between $40-45/hr based on experience

Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.

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