Volpi Group · 6 days ago
Project Engineer, New Product Introduction (NPI)
Auburn, NY
Full-time
Onsite
Senior Level, Lead/Staff
$90K/yr - $120K/yr
10+ years expVolpi Group is a leading innovator in next-generation instrumentation for human diagnostics and life sciences. They are seeking a Project Engineer focused on New Product Introduction (NPI) to drive projects from design transfer through manufacturing ramp-up, blending tactical project management with hands-on engineering.
Health CareManufacturingMedical Device
Responsibilities
Hands-on Engineering and Implementation
Develop and document manufacturing processes using MS Office applications, CAD models, and SolidWorks
Plan and execute IQ/OQ/PQ and test method validation (TMV); analyze data (GR&R, capability, DOE) and release to production
Specify and commission equipment, fixtures, and jigs
Partner with Procurement/Suppliers for PPAP/FAI and change control
Establish SPC/controls; hand off control plan and training to Manufacturing/Quality
Support Lifecycle Management of existing products
Tactical Project Management
Build, maintain, and execute integrated NPI plans (scope, schedule, budget, resources, risks/mitigations)
Own day‑to‑day tactical execution : standups, issue reviews
Maintain gate deliverables: DMR/DHF content, verification/validation summaries, readiness checklists, and training plans in accordance with ISO 13485 requirements
Manage changes: ECOs, deviations, waivers; ensure configuration control and effectivity planning
Develop and implement BOMs and (Bills of Operations) BOOs for new products using ERP system
Qualification
Required
Bachelor's degree in Mechanical, Industrial, Manufacturing, Electrical, or Biomedical Engineering or related field
10-15 years in NPI, manufacturing, or process engineering, ideally within medical devices/diagnostics or similarly regulated industry
Proficiency in validation (IQ/OQ/PQ), statistics (capability, GR&R, SPC), and root‑cause tools
Advanced proficiency in Microsoft Office applications
Excellent verbal and written communication skills
Ability to travel to Volpi Switzerland, customers, and suppliers (up to ~10% required)
Preferred
Lean Six Sigma Green Belt training and/or certification
SolidWorks expertise
Experience with ERP/MRP is a plus (SAP preferred)
Project Management experience is a plus
Benefits
401(k): Company match up to 8% dollar-for-dollar
Health coverage: Majority company-paid premium, with additional low-cost supplemental options
Dental & vision: Company paid
Development: Targeted training and long-term growth opportunities
Work culture: Independent, varied role in a collaborative international environment
Extras: Flat hierarchies, short decision paths, employee events, and a motivated, supportive team
Company
Volpi Group
To In Vitro Diagnostics and Life Sciences instrument manufacturers seeking to improve healthcare outcomes, Volpi Group is the optoelectronics innovator enabling leaps in measurement accuracy through its proven performance, individualized approach, and enabling solutions.
51-200 employees
Funding
Current Stage
Growth StageLeadership Team
Christoph Bohli
CEO Volpi Group and Board Member
Company data provided by crunchbase