Freelance Medical Device Design 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.

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.

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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