Senior Medical Device Process Engineer NPI Manufacturing

Ascendpm; Dublin; On-site; EUR 75,000 - 95,000; Full time

Job summary

Ascendpm is seeking an experienced Process Engineer to design and implement advanced manufacturing processes for medical device production. You will work with Global Device Engineering and Manufacturing to take concepts from development to full-scale floor implementation.

The role requires strong analytical skills, project management, and experience with IQ/OQ/PQ validation and 21 CFR Part 820 compliance. 5+ years in the medical device field is expected.

Qualifications

• Minimum of 5 years of experience in the medical device industry.
• Bachelor's degree (Level 8) in Engineering or Science.
• Strong knowledge of FDA 21 CFR Parts 801 and 820, ISO13485.

Responsibilities

• Design and develop robust, high-yield manufacturing processes.
• Optimize equipment to transfer processes to full-scale manufacturing.
• Collaborate with GDE teams to transition new devices to production.
• Manage external vendors for equipment design, build and site integration.
• Drive continuous improvement for NPIs and equipment upgrades.
• Prepare and maintain detailed process and manufacturing documentation.
• Author validation protocols (IQ/OQ/PQ) for equipment and processes.
• Support cross-functional teams to meet current and future manufacturing needs.
• Act as site-level expert in manufacturing technologies.

Skills

Process engineering

Manufacturing optimization

Analytical thinking

Project management

Education

Bachelor's degree in Engineering or Science

Tools

IQ/OQ/PQ protocols

MS Office

Job description

Ascendpm is seeking an experienced Process Engineer to design and implement advanced manufacturing processes for medical device production. You will work with Global Device Engineering and Manufacturing to take concepts from development to full-scale floor implementation.

The role requires strong analytical skills, project management, and experience with IQ/OQ/PQ validation and 21 CFR Part 820 compliance. 5+ years in the medical device field is expected.