Mechanical Engineer II

Overview 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. With more than 6,000 employees and operations in over 130 countries, we provide fast, accurate and consistent testing where and when they are needed most – from hospitals to laboratories to clinics. Our culture prioritizes employee happiness, inspiration and engagement and we are mission‑driven to transform the power of diagnostics into a healthier future for all. Role Mechanical Engineer II – Sustaining Engineering (Life Cycle Management) for QuidelOrtho’s Transfusion Medicine and Clinical Chemistry / Immunoassay instrument platforms. This onsite role is based in Rochester, NY. The Engineer will own design change projects, from scoping through qualification and production cut‑in, and provide day‑to‑day production support as an R&D representative. Responsibilities Contribute to and/or lead design and analysis efforts on multiple sustaining engineering projects. Drive the design change process from conception through implementation. Collaborate across multiple functions, including part and assembly suppliers. Review and update Design History File documents such as Design Specifications, Subsystem Requirements Documents, FMECA Analysis, and Verification Test Plans/Reports. Participate in design reviews, suggest improvements, and provide feedback as an R&D representative. Develop and execute test plans, protocols, and reports for design changes from early development feasibility through formal verification. Lead or participate in root‑cause investigations and recommend corrective actions in the field of mechanical engineering. Perform other work‑related duties as assigned. Qualifications Bachelor’s degree in mechanical engineering with 3‑5 years of experience, or a master’s degree with at least 1 year of experience. Strong verbal and written communication skills, with the ability to convey complex technical information to diverse audiences and influence cross‑functional parties. Excellent mechanical aptitude, analytical abilities, troubleshooting, and problem‑solving skills with a focus on innovative solutions. Strong customer focus to ensure the product experience meets expectations. Results orientation: ability to set priorities, deliver on time and on budget in a highly regulated environment. Situational adaptability: can anticipate future concerns and quickly earn trust and respect. Travel up to 10% domestic and international. Current position no visa sponsorship. Preferred Qualifications Familiarity with regulated environments such as medical device, aerospace, automotive. Experience with medical device regulations and standards (e.g., FDA, ISO13485). Knowledge of Clinical Chemistry and/or Immunohematology in‑vitro diagnostic instruments. Design for Manufacturability and Serviceability experience. Work Environment The work is performed in a manufacturing, laboratory or warehouse setting. Employees may handle viral and bacterial hazards, hazardous chemicals, infectious or potentially infectious bodily fluids, tissues or samples. Approximately 50% of the time is spent in meetings, and 50% at a desk or in a lab performing analytical tasks. Flexible hours accommodate project deadlines, and occasional domestic and international travel (airplane, automobile, overnight hotel) is required. Physical Demands No strenuous physical activity; occasional light lifting of files, equipment, or related materials is required. Salary Transparency The salary range for this position is $78,000–$90,000 and is bonus eligible. Compensation decisions are based on education, experience, skills, geography and internal equity. Benefits QuidelOrtho offers a comprehensive benefits package including medical, dental, vision, life and disability insurance, a 401(k) plan, employee assistance program, Employee Stock Purchase Plan, paid time off (including sick time), and paid holidays. 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 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 they can perform the duties. If you require special assistance or an accommodation to apply due to a disability, please contact us at View email address on click.appcast.io. #J-18808-Ljbffr Ortho Clinical Diagnostics