Senior Manufacturing Engineer

QuidelOrtho • Rochester, NY

16d • $89,000 - $142,000

About The Position

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 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 customer’s site. The Senior 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.

Requirements

• 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.

Nice To Haves

• 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).

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.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level