Senior Medical Device Manufacturing Engineer

Integra-Lifesciences; Prospect (CT); On-site; USD 71,000 - 98,000; Full time

Job summary

Integra LifeSciences is seeking an experienced mechanical engineer to plan and design manufacturing processes for medical device components. The role involves analyzing current methods, developing prototypes, and collaborating with technicians, machinists, and management to improve efficiency and document processes.

The candidate will lead projects, write engineering test protocols and IQ/OQ/PQ, and work with RA/QA and cross-functional teams to ensure regulatory compliance and successful product

Qualifications

• BS degree in Mechanical Engineering or Equivalent with at least eight (8) years of related engineering experience; or MS in relevant discipline with at least five (5) years of related engineering experience.
• Ability to effectively solve complex problems and communicate across all levels.
• Medical device experience is desired.
• Proficiency with development tools (SolidWorks, AutoCAD) used by the department.
• Knowledge of GMPs, ISO 13485 Design Control, and Manufacturing Process IQ/OQ/PQ qualifications.

Responsibilities

• Works with engineering to design and test prototypes of new products and processes.
• Prepares cost and time estimates for engineering projects.
• Writes qualification protocols and reports (IQ/OQ/PQ) and PV.
• Leading teams through complex projects and coordinating with RA/QA and cross-functional groups.
• Assists in product/process development and transfer to manufacturing.

Skills

Problem solving

Verbal & written communication

Team leadership

Regulatory knowledge

Education

BS in Mechanical Engineering or equivalent

MS in relevant discipline

Tools

SolidWorks

AutoCAD

MRP/ERP systems

Job description

Integra LifeSciences is seeking an experienced mechanical engineer to plan and design manufacturing processes for medical device components. The role involves analyzing current methods, developing prototypes, and collaborating with technicians, machinists, and management to improve efficiency and document processes.

The candidate will lead projects, write engineering test protocols and IQ/OQ/PQ, and work with RA/QA and cross-functional teams to ensure regulatory compliance and successful product