Quality Engineer Medical Device Jobs in Rochester, NY

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.

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 us in our mission to transform the power of diagnostics into a healthier future for all.

The Role

At QuidelOrtho, we're advancing the power of diagnostics for a healthier future for all. 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.

System Engineers at this level have extensive experience and expertise in the field of systems engineering. They possess in-depth knowledge of systems engineering principles, processes, tools, and are often involved in high-level planning, integration, and optimization of complex systems. This role requires advanced problem-solving skills, the ability to lead a smaller team on large-scale projects, and a commitment to ongoing professional development. Additional responsibilities may include management of large technical projects or processes that span outside the immediate job area. Work is performed with limited oversight. Position may include the management of a team of 1-5 junior systems engineers.

This position will be onsite 4 days a week with one day remote in Rochester, NY.

The Responsibilities

• Gather, analyze, and manage system requirements, ensuring alignment with regulatory standards and customer needs
• Conduct risk analysis and mitigation strategies, including Failure Modes and Effects Analysis (FMEA) and Fault Tree Analysis (FTA).
• Lead formal design reviews; provide system-level perspective and ensure compliance with design controls.
• Drive instrument development by creating a plan of execution using his/her knowledge and ability to derive unique solutions and approaches, which are cost effective and contribute to the success of the project.
• Utilize modeling, simulation, and data analytics to assess system behavior and optimize design performance.
• Diagnose and resolve system-level issues, ensuring timely delivery of solutions. Use system engineering tools to carry out Root Cause
• Investigations and determine corrective and preventative action plans.
• Provide status updates as needed to senior leadership, highlighting progress, risks, and mitigation plans.
• Responsible for making moderate to significant improvements of processes, systems or products to enhance performance of technical job area.
• Apply Six Sigma methodologies to identify, analyze, and improve processes within the development and manufacturing of medical devices.
• Develop and execute system level test plans and protocols to validate system performance, reliability growth, and safety
• Conduct statistical analysis to determine appropriate sample sizes for verification and validation activities, ensuring robust and reliable results.
• Collaborate with key stakeholders and external design partners to deliver product features that improve our customer experience, product performance and safety.
• Perform other work-related duties as assigned.

The Individual

Required:

• Bachelor's Degree in System Engineering, Biomedical Engineering, or related engineering field with strong cross-discipline experience is required, master's degree preferred.
• Minimum 8+ years relevant experience required with a track record of delivering products in the medical, automotive, and/or defense industries, preferably with relevant medical device design exposure.
• Demonstrated experience using Six Sigma tools and techniques for process optimization and quality improvement
• Demonstrated experience in applying statistical techniques to real-world problems, particularly in the medical device industry.
• 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.
• Results orientation: Must be capable of making commitments, setting priorities, and delivering results in time and on budget in a highly regulated environment.
• Situational Adaptability: Sees ahead clearly; can anticipate future concerns.
• Develops and maintains effective cross functional relationships and is capable of quickly earning trust and respect.
• Must have the ability to travel 10% both domestic and international.
• This position is not currently eligible for visa sponsorship.

Preferred:

• Familiarity with medical device regulations and standards (e.g., FDA, ISO 13485, etc.)
• Demonstrated experience in successfully working with external development partners in delivering complex solutions.
• Familiarity with Clinical Chemistry and/or Immunohematology in vitro diagnostic instruments.

The Key Working Relationships

Internal Partners:

• R&D Leadership
• Quality
• Regulatory
• Service
• Manufacturing
• Marketing
• Project Management

External Partners:

• Clinical chemistry and transfusion medicine personnel (current and potential customers)
• Development partners

How We Work

At QuidelOrtho, our culture is shaped by four core behaviors that guide how we collaborate, make decisions, and support each other and those we serve. The ideal candidate will exhibit these behaviors, as we believe they're essential to how we thrive as a team and achieve meaningful impact:

• Thrive Together - Collaborate intentionally, grow as a team
• Make It Happen - Focus on priorities, embrace continuous improvement
• Commit to Service - Cultivate a service mindset
• Embrace Inclusion - Be open and authentic, welcome diverse perspectives

The Work Environment

If the work environment is mainly typically in the lab/warehouse/production line, use verbiage like:

The work environment characteristics are representative of a laboratory, or office environment and include handling of viral and bacterial hazards, potentially hazardous chemicals, as well as infectious or potentially infectious bodily fluids, tissues, and samples. Up to 75% of the time at desk, standing or sitting extended periods of time. Flexible work hours to meet project deadlines.

Physical Demands

No strenuous physical activity, though occasional light lifting of files and related materials is required. 30% of time in meetings, working with team, or talking on the phone, 70% of the time at the desk on computer, doing analytical work. Minimal travel required. Travel includes airplane, automobile travel and overnight hotel.

Salary Transparency

The salary range for this position takes into account a wide range of factors including education, experience, knowledge, skills, geography, and abilities of the candidate, in addition to internal equity and alignment with market data. At QuidelOrtho, it is not typical for an individual to be hired at or near the top range for their role and compensation decisions are dependent on the facts and circumstances of each case. The salary range for this position is $125,000 to $135,000 and is bonus eligible. QuidelOrtho offers a comprehensive benefits package including medical, dental, vision, life, and disability insurance, along with a 401(k) plan, employee assistance program, Employee Stock Purchase Plan, paid time off (including sick time), and paid Holidays. All benefits are non-contractual, and QuidelOrtho may amend, terminate, or enhance the benefits provided, as it deems appropriate.

Equal Opportunity

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. 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.

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