Orthoclinical

Orthoclinical

Staff Systems Engineer, Medical Device

US - NY - Rochester · Staff+

H1B sponsorship available$125k-$135kDetected 30 days ago
Data AnalysisStatisticsProject ManagementProcess ImprovementSystems EngineeringHardware DesignFDA RegulatoryMedical DevicesLeadershipCommunicationProblem SolvingMentoringAdaptability

About the role

  • QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine.
  • We are more than 6,000 strong and do business in over 130 countries, providing answers with fast, accurate and consistent testing where and when they are needed most - home to hospital, lab to clinic.
  • Join us in our mission to transform the power of diagnostics into a healthier future for all.

Responsibilities

  • Gather, analyze, and manage system requirements, ensuring alignment with regulatory standards and customer needs
  • Lead formal design reviews; provide system-level perspective and ensure compliance with design controls.
  • Utilize modeling, simulation, and data analytics to assess system behavior and optimize design performance.
  • Develop and execute system level test plans and protocols to validate system performance, reliability growth, and safety
  • Collaborate with key stakeholders and external design partners to deliver product features that improve our customer experience, product performance and safety.
  • Development partners
  • Thrive Together - Collaborate intentionally, grow as a team

Nice to have

  • Bachelor's Degree in System Engineering, Biomedical Engineering, or related engineering field with strong cross-discipline experience is required, master's degree preferred.
  • Demonstrated experience using Six Sigma tools and techniques for process optimization and quality improvement
  • Demonstrated experience in systems engineering tools and methodologies, as well as experience with software development, hardware design, reliability growth testing and systems integration.
  • Strong verbal and written communication skills, with the ability to convey complex technical information to diverse audiences.
  • Ability to work effectively in a collaborative, cross-functional team environment.
  • Including the mentoring of more junior engineers.
  • Strong analytical and problem-solving skills, with a focus on delivering innovative solutions.
  • Must have strong customer focus to ensure that the experience delivered by the product is consistent with expectations.

Skills

  • Diagnose and resolve system-level issues, ensuring timely delivery of solutions. Use system engineering tools to carry out Root Cause

Compensation

  • Salary Transparency

Benefits

  • The salary range for this position is $125,000 to $135,000 and is bonus eligible.
  • Apply Six Sigma methodologies to identify, analyze, and improve processes within the development and manufacturing of medical devices.

Company info

  • Our culture puts our team members first and prioritizes actions that support happiness, inspiration and engagement.
  • We strive to build meaningful connections with each other as we believe that employee happiness and business success are linked.
  • Join our mission as our next Staff Systems Engineer to support new product development.
  • We are looking for a motivated Staff Systems Engineer for in vitro diagnostic instrument development who will provide technical leadership and contribution to product design for QuidelOrtho's instrument platforms.
  • Clinical chemistry and transfusion medicine personnel (current and potential customers)
  • Embrace Inclusion - Be open and authentic, welcome diverse perspectives

Equal opportunity

  • QuidelOrtho is also committed to providing reasonable accommodations to qualified individuals so that an individual can perform the duties.
  • If you are interested in applying for an employment opportunity and require special assistance or an accommodation to apply due to a disability, please contact us at recruiting@quidelortho.com. #LI-TO1
  • QuidelOrtho believes in Equal Opportunity for all and is committed to ensuring all individuals, including individuals with disabilities, have an opportunity to apply for those positions that they are interested in and qualify for without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, age, veteran status, disability, genetic information, or any other protected characteristic.
  • If you are interested in applying for an employment opportunity and require special assistance or an accommodation to apply due to a disability, please contact us at recruiting@quidelortho.com.

Visa & Work Authorization

  • This position is not currently eligible for visa sponsorship.
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This listing is sourced directly from Orthoclinical's careers page and normalized into a canonical job model.