Senior Manufacturing Engineer, Medical Devices

Integra LifeSciences; Prospect (CT); Vor Ort; USD 71.000 - 98.000; Vollzeit

Benefits dieser Stelle

Medical

Dental

Vision

401(k)

Zusammenfassung

Integra LifeSciences is seeking an experienced Mechanical Engineer to design manufacturing processes and tools for medical device components. You will analyze existing methods, document equipment functions, and support audits as the SME for assigned product lines.

Responsibilities include leading engineering prototypes, developing test protocols, and coordinating with cross-functional teams to implement new products and transfers, while ensuring GMP and quality standards are met.

Qualifikationen

• BS in Mechanical Engineering or equivalent with 8+ years of related experience or MS with 5+ years.
• Ability to solve complex problems and communicate across all teams.
• Medical device experience is desirable.
• Proficiency with engineering tools (SolidWorks, AutoCAD) used by the dept.
• Knowledge of GMPs, ISO 13485 Design Control, and IQ/OQ/PQ qualifications.

Aufgaben

• Plan and design manufacturing processes and tooling for medical device components.
• Lead teams on complex engineering projects and product transfers.
• Prepare cost and time estimates for engineering and project schedules.
• Write protocols for testing and qualification of components and systems.
• Collaborate with RA/QA and Marketing on new product introductions.

Kenntnisse

Problem solving

Cross-functional communication

Leadership

Verbal and written communication

Ausbildung

BS in Mechanical Engineering or equivalent

MS in relevant discipline

Tools

SolidWorks

AutoCAD

MRP/ERP systems

Jobbeschreibung

Integra LifeSciences is seeking an experienced Mechanical Engineer to design manufacturing processes and tools for medical device components. You will analyze existing methods, document equipment functions, and support audits as the SME for assigned product lines.

Responsibilities include leading engineering prototypes, developing test protocols, and coordinating with cross-functional teams to implement new products and transfers, while ensuring GMP and quality standards are met.