Senior Medical Device Manufacturing Engineer

INTEGRA LIFESCIENCES CORP; Prospect (CT); On-site; USD 71,000 - 98,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

Life Insurance

Disability Insurance

401(k) Savings Plan

Job summary

Integra LifeSciences is seeking a seasoned Mechanical Engineer to design and optimize manufacturing processes for medical device components. The role requires leading engineering designs, prototyping, and testing, while guiding cross-functional teams through complex projects.

Ideal candidates have a strong background in GMPs, ISO 13485 Design Control, and IQ/OQ/PQ qualifications, with proven ability to drive efficiency and regulatory-compliant engineering changes in a fast-paced environment.

Qualifications

• BS in Mechanical Engineering or equivalent with 8+ years of related eng experience (MS with 5+ years).
• Ability to solve complex problems and communicate across all functional groups and levels.
• Excellent verbal and written communication skills.
• Medical device experience is desired; knowledge of GMPs, ISO 13485 Design Control, and related IQ/OQ/PQ qualifications.

Responsibilities

• Plans and designs manufacturing processes and methods for medical device components.
• Analyzes data and acts as SME; supports audits and shop floor change control.
• Designs and prototypes new products/processes with engineering team.
• Prepares cost and time estimates for projects and schedules.
• Writes engineering test protocols and qualification reports (IQ/OQ/PQ, PV).
• Leads and collaborates on transfers, new product introductions, and CapEx projects.

Skills

B.S. in Mechanical Eng

MS in related field

8+ years engineering experience

Problem solving

Excellent verbal & written comms

Medical device exp. desired

Development tools: SolidWorks

Development tools: AutoCAD

Engineering Change Order System

Lead teams on complex projects

GMPs / ISO 13485 knowledge

Regulatory documentation/ASQ

Education

B.S. in Mechanical Engineering

M.S. in relevant discipline

Tools

SolidWorks

AutoCAD

Job description

Integra LifeSciences is seeking a seasoned Mechanical Engineer to design and optimize manufacturing processes for medical device components. The role requires leading engineering designs, prototyping, and testing, while guiding cross-functional teams through complex projects.

Ideal candidates have a strong background in GMPs, ISO 13485 Design Control, and IQ/OQ/PQ qualifications, with proven ability to drive efficiency and regulatory-compliant engineering changes in a fast-paced environment.