Senior Manufacturing 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 6000 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 we continue to grow as QuidelOrtho we are seeking a Senior Manufacturing Engineer. The Senior Manufacturing Engineer will 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 Senior Manufacturing Engineer 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 customers Senior Manufacturing Engineer uses knowledge of scientific techniques and Process Excellence to design and develop safe effective and efficient processes in support of the companys strategies goals objectives and product portfolio. They observe all regulatory requirements (GMPs 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.

The Responsibilities

• For NPI and LCM Programs work closely with R&D Quality and Ortho Care leading team activities to resolve manufacturing issues identified through Specification Variance (SV) and Supplier Change Request (SCR) processes .

• For NPI and LCM Programs the Senior Manufacturing Engineer will be responsible for part and assembly qualification utilizing Production Part Approval Process (PPAP) data provided by the external manufacturing partner and collaborating with Ortho R&D Quality and Ortho Care to provide Ortho approval.

• For NPI and LCM Programs the individual will be responsible to review drawing and make recommendations for cost reduction opportunities. The engineer will also be responsible to drive drawing changes in the PLM system.

• Provide Red-lines for drawing changes.

• Provide technical resources to manufacturing related fixtures located at external suppliers.

The Individual

Required:

• BA/BS with 5-10 years experience or MS with 5-7 years experience or 15 years experience in a Manufacturing and/or R&D Engineering Role.

• Products primarily supported by this position will require an electromechanical device process development engineering skill set.

• Strong communication (both written and verbal) as well as influencing skills as interaction with multiple functions and various suppliers.

• Proficiency with Microsoft Office.

• Proficient in reading and interpreting GD&T tolerance analysis.

• Proficient in reading and interpreting electrical schematics and system level diagrams.

• Proficient in problem solving and troubleshooting to root cause.

• Proficient in Risk Management tools such as FMEAS PFMEAS.

• Able to design and perform process qualifications using IQ/OQ/PQ too.

• Coach less experienced engineers in process/design changes.

• Lead by example when completing daily work. Work within the team dynamic to promote Win-Win solutions to problems.

• Ownership and accountability to project results is clearly demonstrated.

Preferred:

• Demonstrated ability to lead elements of complex technical projects confidently is strongly.

• Experience in an FDA regulated and/or GMP environment.

• Experience in process improvement efforts using Process Excellence Six Sigma and Lean Tools.

• Broad-based knowledge of assembly and component manufacturing processes within the Diagnostics and/or Medical Device Industry.

• Knowledge of Product Data Management tools (PDM).

Key Working Relationships

Internal Partners: R&D Engineers Project Managers Project Leaders Quality Regulatory Manufacturing Procurement Planning Ortho Care

External Partners: Consultants Contract employees External partners for outsourced development / professional services component and full assembly suppliers

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. Up to 75% of the time you will be standing walking or sitting for extended periods of time. Ability to lift up to 50 lbs. 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 $89000.00 to $142000.00 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 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 r.

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