QuidelOrtho · 18 hours ago
Senior Manufacturing Engineer
US - NY - Rochester
Full-time
Onsite
Mid, Senior Level
$89K/yr - $142K/yr
5+ years expQuidelOrtho is a world-leading in vitro diagnostics company that focuses on transforming the power of diagnostics into a healthier future. The Senior Manufacturing Engineer will provide technical support for changes initiated by the contract manufacturer, collaborating with cross-functional teams to ensure effective manufacturing processes and compliance with regulatory requirements.
Medical Device
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
Qualification
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)
Benefits
Medical
Dental
Vision
Life
Disability insurance
401(k) plan
Employee assistance program
Employee Stock Purchase Plan
Paid time off (including sick time)
Paid Holidays
Company
QuidelOrtho
> Bringing precision and passion in everything we do QuidelOrtho stands at the forefront of testing, tracking and disease analysis of health conditions ranging from HIV and hepatitis C to flu, strep and COVID-19.
5001-10000 employees
Funding
Current Stage
Late StageLeadership Team
Joe Busky, CPA
Chief Financial Officer
Michael Iskra
Executive Vice President and Chief Commercial Officer
Recent News
2025-12-18
2025-11-06
2025-11-06
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