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.

• 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.

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

Internal Partners:

Quality, Regulatory, Service, Manufacturing, Marketing, Project Management and Procurement

External Partners:

Developmental Partners

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.

No strenuous physical activity, though occasional light lifting of files, equipment, and related materials is required.

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.

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