Lead Project Engineer, Medical Devices (Utilities & Equipment)

INTEGRA LIFESCIENCES PRODUCTION CORPORATION; Mansfield (MA); On-site; USD 94,000 - 130,000; Full time

Benefits offered by this job

Medical benefits

Dental benefits

Vision benefits

Life insurance

Short/long-term disability

401(k) retirement plan

Job summary

Integra LifeSciences is seeking a Senior Project Engineer II - Utilities & Equipment in the United States to lead cross‑functional engineering initiatives spanning facilities, equipment, and processes for medical device development under GMP/ISO regulations.

You will drive end‑to‑end projects from concept through validation to launch, mentor teams, and ensure compliance with FDA, ISO 9001/13485, EU MDR, CMDR, and related standards while coordinating with product development and regulatory groups.

Qualifications

• SPC tools and statistical analysis experience required.
• Lean Six Sigma experience essential.
• Strong organizational and English communication skills.
• PM experience and PMP is desirable.
• ERP/CRM usage and MS Office proficiency required.

Responsibilities

• Develop cross‑functional network across EHS, site teams, and manufacturing to execute projects.
• Lead strategic site and enterprise projects addressing quality improvements and lifecycle management.
• Plan and implement IQ/OQ/PQ/TMV validations and engineering changes.
• Analyze process parameters to improve yields and reduce scrap using lean methods.
• Lead CAPA investigations and risk mitigation in collaboration with QA/regulatory.
• Manage budgets, resources, and transfer new products to manufacturing.

Skills

SPC tools

Lean Six Sigma

English communication

Project management

MS Office

Education

Bachelor’s degree in engineering or equivalent

Master’s degree in engineering or related field

Tools

SAP ERP

CRM platforms

MS Project

Jira

Excel

Job description

Integra LifeSciences is seeking a Senior Project Engineer II - Utilities & Equipment in the United States to lead cross‑functional engineering initiatives spanning facilities, equipment, and processes for medical device development under GMP/ISO regulations.

You will drive end‑to‑end projects from concept through validation to launch, mentor teams, and ensure compliance with FDA, ISO 9001/13485, EU MDR, CMDR, and related standards while coordinating with product development and regulatory groups.