Senior Project Engineer II, Medical Devices Utilities & Equipment

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

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

Life Insurance

Disability Insurance

401(k)

Job summary

Integra LifeSciences is seeking a Senior Project Engineer II - Utilities & Equipment to lead cross-functional engineering initiatives for medical devices, from concept through launch, ensuring regulatory and quality compliance.

The role requires experience with GMP, ISO 9001/13485, and regulatory standards (FDA, EU MDR). Strong leadership, problem solving, and communication in English are essential.

Qualifications

• 8+ years of engineering experience or a Master’s degree with 3+ years of experience.
• Experience with statistical process control tools (SPC, Minitab, other software) required.
• Lean Six Sigma experience required.

Responsibilities

• Develop cross-functional networks to execute projects across facilities, equipment, and processes.
• Lead strategic site and enterprise projects addressing quality improvements and lifecycle management.
• Prepare engineering studies, IQ/OQ/PQ/TMV validations, and engineering change requests.

Skills

SPC

Lean Six Sigma

Project management

English communication

ERP knowledge

Education

Bachelor’s degree in engineering or equivalent

Master’s degree in engineering or related field

Tools

SAP

MS Project

Jira

MS Office

Job description

Integra LifeSciences is seeking a Senior Project Engineer II - Utilities & Equipment to lead cross-functional engineering initiatives for medical devices, from concept through launch, ensuring regulatory and quality compliance.

The role requires experience with GMP, ISO 9001/13485, and regulatory standards (FDA, EU MDR). Strong leadership, problem solving, and communication in English are essential.