Manufacturing Engineer I

As we continue to grow as one QuidelOrtho, we are seeking a Manufacturing Engineer I to work in our manufacturing facility. The Manufacturing Engineer I would be the primary technical support for all changes initiated by the contract manufacturer. They provide the technical input to change requests from the contract manufacturer working with cross-functional teams including: R&D, Quality Engineering, Field Service Teams, Procurement, Manufacturing, and Environmental/Safety. The Manufacturing Engineer I will conduct detailed analysis of requests and provide guidance, assistance, and technical solutions to facility the change. This individual will track all changes, attend obsolescence meeting, process non-conformances, review incoming inspection plans, work directly with external suppliers, review work instruction, troubleshoot part problems, and fixture repairs. This person is also a support for part quality issues that may occur at the supplier, the manufacture, or at the customer's site. The Manufacturing Engineer uses knowledge of scientific techniques and Process Excellence to design and develop safe, effective, and efficient processes in support of the company's strategies, goals, objectives and product portfolio. They observe all regulatory requirements (GMP's, ISO, FDA, internal policies) applicable to their area of responsibility and comply with safety / Environmental Requirement and safe working conditions and practices.

Typical responsibilities may include evaluating existing manufacturing processes and identifying areas for improvement. Determining problem resolutions and implementing improvements. Developing detailed layouts for equipment, processes, and workflow. Researching and developing new processes, equipment, and products. Developing and implementing cost-saving measures and quality control systems. Ensuring manufacturing processes, equipment, and products comply with safety standards and legal regulations.

This position is in Rochester, NY.

• Drives the disposition and change requests from contract manufacturers that includes R&D and Quality.

• Review specification variance packages for completeness for processing in QuidelOrtho' s Quality and Change Control systems.

• Interact with supplier as needed on specification variances and obtain crucial prioritization.

• Posses the ability to put together a presentation for each change request.

• Understand the Quality Tracking System to process any accepted Spec variances as the change is processed, and tasks are completed and closed in the quality record.

• Provide Red-lines to drawing changes until supplier can adequately provide red-lines.

Required:

• BA/BS with <2 years experience or MS with no experience. May include entry-level engineering training or internship.

• Entry level, learning routine and typical aspects of the engineer role.

• Basic understanding and application of standard Engineering/Manufacturing theories, concepts, principles and techniques in one of the following engineering disciplines: Mechanical, Manufacturing Engineering

• Able to use standardized test equipment to solve a variety of basic technical problems related to the development, testing, calibration, validation and maintenance of experimental, prototype and existing laboratory and manufacturing equipment.

• Knowledge of emerging technology trends.

• Uses deductive reasoning to solve a variety of basic engineering problems related to calculations, tests, and design details.

• Capable of tracking a plan for a small project. Uses available tools to organize desk, calendar, and daily tasks.

• Written and verbal communication is clear and concise. Works with management to select the appropriate media for the target audience.

• Should have an awareness of some Process Excellence tools

• Ability to work well within the team environment. Should be able to follow direction from team leaders for deliverables. Sphere of influence is limited to the members of a project team.

• Determines root cause and implements practical solutions to component-level problems. Example problems: Tolerance Analysis, Component obsolescence (simple substitution)

Internal Partners: Manufacturing Operations and other product release laboratories: PAR (Performance Assignment and Release), Reference; Product Support, R&D, Complaint Handling Unit and Customer Technical Services.

External Partners: College of American Pathologists, NGSP-University of Missouri (for certifications), CEQAL- Vancouver, BC (for certifications).

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

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 $68,000 - $98,000 . 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.

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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