Senior Medical Device Project Engineer

Integra LifeSciences Corporation; Mansfield (MA); In loco; USD 94.000 - 130.000; Tempo pieno

Descrizione del lavoro

Integra LifeSciences Corporation in Mansfield, MA seeks a Senior Project Engineer II to lead cross-functional teams in designing, validating, and transferring medical devices through development to launch. You will manage IQ/OQ/PQ validations, risk analyses, CAPA, and supply chain integration while ensuring GMP, ISO 13485, and EU MDR compliance.

The role emphasizes project leadership, budgeting, and collaboration with manufacturing, QA, regulatory, and suppliers to meet technical and schedule

Competenze

• Bachelor’s degree in engineering or equivalent; 8+ years experience or Master’s with 3+ years.
• Experience with SPC tools and Minitab or similar software.
• Lean Six Sigma experience required.
• Strong organizational and English communication skills (oral & written).
• PM and process improvement experience; PMP desired.
• Knowledge of ERP/MRP and MS Office; familiarity with SAP and Jira.

Mansioni

• Lead cross-functional engineering initiatives to design, validate, and commercialize medical devices.
• Manage end-to-end project execution from concept through product launch.
• Perform IQ/OQ/PQ validations, CAPA, FMEA, and risk management activities.
• Coordinate with manufacturing, quality, regulatory, suppliers, and external partners.
• Track budgets, timelines, and resource forecasting across projects.

Conoscenze

Statistical process control (SPC)

Lean Six Sigma

Project management

English communication

ERP / MRP knowledge

MS Office

Jira

MS Project

QMS platforms

Quality system integration

Formazione

Bachelor's degree in engineering or equivalent

Master’s degree (preferred)

Strumenti

SAP

MS Project

Jira

CRM platforms

Descrizione del lavoro

Integra LifeSciences Corporation in Mansfield, MA seeks a Senior Project Engineer II to lead cross-functional teams in designing, validating, and transferring medical devices through development to launch. You will manage IQ/OQ/PQ validations, risk analyses, CAPA, and supply chain integration while ensuring GMP, ISO 13485, and EU MDR compliance.

The role emphasizes project leadership, budgeting, and collaboration with manufacturing, QA, regulatory, and suppliers to meet technical and schedule