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$78k–$90k/yr
Full-time
bachelor degree, postgraduate degree
Medical Insurance, Dental Insurance, Vision Insurance, Life Insurance, Disability Insurance, 401(k) Plan
Posted 28d ago
~40 hrs/week
Responsibilities
The role focuses on providing technical ownership for sustaining engineering projects and life cycle management for diagnostic instrument platforms. Responsibilities include driving design changes from conception to implementation and performing root cause investigations for field issues.
Requirements
Requires a Bachelor's degree in Mechanical Engineering with 3-5 years of experience, or a Master's degree with at least 1 year of experience. Candidates must possess strong analytical skills and the ability to work in a highly regulated environment.
Full job description
The Opportunity
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 Mechanical Engineer II. This role will provide technical contributions and/or ownership for Sustaining Engineering projects (Life Cycle Management) for QuidelOrtho’s Transfusion Medicine and Clinical Chemistry / Immunoassay instrument platforms.
The candidate will be a self-starter, willing to assume ownership of deliverables and is expected to participate in and/or own design change projects from initial scoping through qualification and production cut-in. Work content includes redesign for obsolescence & enhancements, field issue investigation and resolution support, and day-to-day production support as an R&D representative. Our projects have a wide range of complexity with durations ranging from a few weeks up to multi-year schedules and provide exposure across many engineering disciplines (electrical, mechanical, software, systems, optics). This role regularly collaborates cross functionally across operations, global service, regulatory, quality, operations, procurement, and publications organizations. Individuals in this role also have an ongoing commitment to professional development and are also provided corresponding mentorship
This position will be onsite in Rochester, NY.
The 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
Collaborate with part/assembly suppliers
Review and/or update Design History File Documents including Design Specifications, Subsystem Requirements Documents, FMECA Analysis and Verification Test Plans/Reports.
Support other teams by participating in design reviews, suggesting improvements, and providing feedback as an R&D representative
Develop and execute test plans, protocols, and reports for design changes from early development feasibility through formal verification
Participate and/or lead root cause investigations and recommend corrective actions in the field of mechanical engineering
Perform other work-related duties as assigned.
The Individual
Required:
Bachelor's degree in mechanical engineering with 3-5 years of experience, Master's degree with at least 1 year of experience
Strong verbal and written communication skills, with the ability to (1) convey complex technical information to diverse audiences, (2) influence cross functional parties within and outside of our functions and organization.
Ability to work effectively in a collaborative, cross-functional team environment.
Strong mechanical aptitude, analytical abilities, troubleshooting, 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 working in a regulated environment i.e. medical device, aerospace, automative,
Familiarity with medical device regulations and standards (e.g., FDA, ISO 13485, etc.)
Familiarity with Clinical Chemistry and/or Immunohematology in vitro diagnostic instruments.
Design for Manufacturability and Serviceability experience
The Key Working Relationships
Internal Partners:
Quality, Regulatory, Service, Manufacturing, Marketing, Project Management and Procurement
External Partners:
Developmental Partners
The Work Environment
The work environment characteristics are representative of a manufacturing, laboratory, or warehouse environment and include handling of viral and bacterial hazards, potentially hazardous chemicals, as well as infectious or potentially infectious bodily fluids, tissues, and samples. 50% of time in meetings, working with team, or talking on the phone. 50% at desk or in lab, performing analysis or analytical tasks Flexible work hours to meet project deadlines. Occasional domestic and international travel required. Travel includes airplane, automobile travel and overnight hotel.
The Physical Demands
No strenuous physical activity, though occasional light lifting of files, equipment, and related materials is required.
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 $78,000 - $90,000 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 [email protected].
#LI-HF1
Related keywords
In Vitro DiagnosticsMedical DeviceFDAISO 13485Design History FileClinical ChemistryImmunoassayTransfusion MedicineLife Cycle ManagementDesign SpecificationsSubsystem RequirementsVerification Test PlansObsolescence RedesignR&DMechanical Aptitude
Changing lives one test at a time – Connect with us and explore how we’re shaping the future of diagnostics.
Industry
Medical Equipment Manufacturing
Company size
5,001-10,000 employees
Founded
1937
LinkedIn followers
53,673
> Bringing precision and passion in everything we do
QuidelOrtho stands at the forefront of testing, tracking and disease analysis of health conditions ranging from HIV and hepatitis C to flu, strep and COVID-19. For decades, our precision and accuracy have guided clinicians and lab technicians in the moments that matter most.
> Continuing our legacy in diagnostics
Our portfolio serves the entire healthcare continuum: from high-volume, high-complexity hospitals and labs to point-of-care, retail and over-the-counter markets. This enables us to continue our legacy of diagnostics in an ever-changing environment where we're passionately pursuing the unknown to advance diagnostic science and care.
> Raising the bar in diagnostic care
Ranked among the world’s largest in vitro diagnostics (IVD) providers, we’re building on more than 120 years of collective experience and innovation. We combine industry-leading expertise in immunoassay and molecular testing with a global footprint in point-of-care settings, clinical labs and transfusion medicine to advance critical diagnostic solutions at scale.
> Powering a healthier future for all
Inspired by a spirit of service, QuidelOrtho is committed to enhancing the wellbeing of people worldwide and happy in the knowledge we are making a difference.
To contact us, please visit https://www.quidelortho.com/global/en/contact-us.
For career opportunities, please visit: https://careers.quidelortho.com/global/en.
#QuidelOrtho #BetterTogether #PowerUpLabs #HealthierFuture #DiagnosticFrontier #AdvancingScience #TalentNetwork
In vitro diagnosticsDiagnosticsClinical labsTransfusion medicineImmunohemotologyRespiratoryPoint of careCOVID-19FluThyroid
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