Senior Plastics Engineer

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

As the company continued to grow we are seeking a Senior Plastics Engineer. The Senior Plastics Engineer will be the technical lead for projects that involve Ortho’s supply base for plastic components. Support will predominantly be provided for Ortho’s injection molded, high volume consumables, but other plastic manufacturing techniques and low-volume plastic components may occasionally require support. The position will provide technical input to change requests initiated by Ortho’s suppliers or changes initiated within Ortho to align with organizational initiatives and continuity of supply of plastic products. Technical expertise will extend to authoring and reviewing the execution of qualifications involving manufacturing processes at suppliers, managing plastic consumable nonconformances, root cause analysis, and corrective actions alongside the Quality organization,  evaluating and executing proper change control processes associated with supplier change requests, and consulting with other areas of the organization where and when technical plastic engineering expertise is requested. This individual will monitor changes, lead regular project meetings, process non-conformances, and work directly with external suppliers.

This position is in Rochester, NY.

The Responsibilities

• Manage capital equipment projects within Ortho's supply base for consumable products. This includes support of projects from design/concept phase through qualification and into production-readiness. Execution may involve writing of supplier qualification protocols and reports, and at minimum will involve review and approval of relevant project documentation for conformance to Ortho requirements.

• Lead technical investigation and cross-functional review of unplanned supplier tasks, including supplier nonconformances and supplier change requests.

• Support and consult on related Ortho projects/initiatives which require plastics expertise; areas may include low-volume molds which support equipment manufacture and R&D projects involving new or changed plastic consumable or equipment products.

The Individual

Required:

• A minimum of a Bachelor’s of Science in engineering or another technical discipline is preferred, or additional equivalent experience will be considered.

• 5+ years of engineering experience in manufacturing or related industry; plastic injection molding experience preferred.

• 3+ years of engineering experience in the regulated medical device industry is preferred.

• In depth knowledge of manufacturing processes and systems.

• Working knowledge of the validation requirements for Medical Devices.

• A demonstrated proficiency in project management, including obtaining agreement on project definitions and priorities and ensuring that resources, capabilities, and processes are in place to deliver the project objectives on time and per budget.

• Proficiency in reading and interpreting two-dimensional drawings and three-dimensional models.

• Working knowledge of GD&T (geometric dimensioning and tolerancing).

• Strong written and verbal communication skills.

• Strong analytical, problem solving, insight generation, and critical thinking skills.

• Self-initiator, results driven and action & detail oriented.

Preferred:

• Working knowledge of injection molding process development (scientific injection molding principles) and familiarity with the plastics industry.

• Capital Equipment Experience (DoD, Aerospace, Medical Devices).

• Working knowledge of Six Sigma/Process Excellence Tools (DMAIIC, DMADV, or Lean) which include Design of Experiments, capability analysis, sampling statistics and techniques, CTQ flow down, C/E Matrix,  pFMEA,  fish bone diagrams, etc.

• Working knowledge of statistical software, including Minitab.

• Strong knowledge of Creo / Pro Engineer and/or Solid Works.

• Required Travel 10-20% primarily domestic.

Key Working Relationship

Internal Partners: Primarily External Manufacturing Quality and Commercial/Procurement business partners, but may also include R&D staff, Project Managers, Other Quality Functions, Regulatory, Manufacturing, Planning

External Partners: Primarily project managers, quality engineers, or process engineers at Ortho suppliers, but may also include Consultants, Contract employees, External partners for outsourced development / professional services, component and full assembly suppliers

The Work Environment

The work environment characteristics are representative of a manufacturing and laboratory, environment.

The Physical Demands

Include handling of viral and bacterial hazards, potentially hazardous chemicals, as well as infectious or potentially infectious bodily fluids, tissues, and samples. Up to 50% of time in meetings, working with team; 50% of the time at the desk on computer, walking, standing, or sitting extended periods of time, doing analytical work are routine to accomplish tasks in this role. Specific vision abilities required by this job include close and distance vision and the ability to adjust focus. Position requires use of Personal Protective Equipment as posted. Flexible work hours to meet project deadlines.

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 $80,000 - $100,000. 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 Employment 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 their 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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