Senior Medical Device Project Lead

Integra-Lifesciences; Mansfield (MA); On-site; USD 94,000 - 130,000; Full time

Job summary

Integra LifeSciences seeks a Senior Project Engineer II to lead cross-functional engineering initiatives for medical devices, guiding projects from concept through launch. You will ensure regulatory and quality requirements are met while coordinating between engineering, manufacturing, quality, regulatory, suppliers and external partners.

The role emphasizes problem-solving, project leadership, and liaison duties under the Engineering Manager, with extensive collaboration across centers of

Qualifications

• Bachelor's degree in engineering or equivalent.
• 8+ years of experience or Master’s degree with 3+ years of experience.
• Excellent organizational and English communication skills (oral & written).

Responsibilities

• Lead cross-functional engineering initiatives for medical devices.
• Design, develop, validate and commercialize products per regulatory standards.
• Plan, execute, and track end-to-end projects from concept to launch.
• Perform investigations, FMEA, CAPA and risk-based improvements.
• Collaborate with regulatory, quality, manufacturing and suppliers.

Skills

Statistical process control

Lean Six Sigma

Project management

English communication

Education

Bachelor's degree in engineering

Master's degree in engineering

Tools

SAP ERP

Jira

MS Project

MS Office

QMS platforms

Job description

Integra LifeSciences seeks a Senior Project Engineer II to lead cross-functional engineering initiatives for medical devices, guiding projects from concept through launch. You will ensure regulatory and quality requirements are met while coordinating between engineering, manufacturing, quality, regulatory, suppliers and external partners.

The role emphasizes problem-solving, project leadership, and liaison duties under the Engineering Manager, with extensive collaboration across centers of