Process Engineer

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

Overview:

We are seeking an experienced Process Engineer to join our clients team, working collaboratively with Global Device Engineering (GDE) and Manufacturing to design and implement advanced, high-performance manufacturing processes for medical device production. This role involves active participation in multiple projects focused on the development, automation, and testing of medical devices, taking process and equipment concepts through to full-scale implementation on the manufacturing floor.

Key Responsibilities:

• Design and develop robust, high-yield manufacturing processes that ensure consistent product quality
• Optimize equipment and process technologies to support the successful transfer of reliable, efficient processes into full-scale manufacturing.
• Collaborate with GDE teams to support the design and seamless transition of new medical devices from development through validation and into production.
• Manage and support external vendors in the design, build, and installation of manufacturing equipment-from initial concept through to factory integration.
• Drive continuous improvement and innovation in existing equipment and processes to support New Product Introductions (NPIs).
• Prepare and maintain detailed process and manufacturing documentation.
• Author and execute validation and qualification protocols (IQ/OQ/PQ) for equipment and processes.\
• Champion ongoing process improvement initiatives to ensure high standards of product quality and efficiency.
• Coordinate with cross-functional teams to support both current and future manufacturing needs.
• Act as a site-level expert in specific manufacturing technologies and support knowledge development within the team.
• Oversee the commissioning and scaling of new manufacturing technologies, with a focus on microcatheter production.
• Conduct risk assessments with Environmental Health & Safety (EHS) teams when introducing new equipment, materials, or chemicals to reduce environmental impact

Education & Experience

• Bachelor's degree (Level 8) in Engineering or Science (Manufacturing, Mechanical, Electronic, Production, or related disciplines).
• Minimum of 5 years of experience in the medical device industry.
• Strong understanding of medical device regulations including FDA standard 21 CFR Parts 801 and 820, design controls, ISO13485, regulatory audits and international environmental regulations. Extensive experience and track record of success in the development of 510K/PMA regulated products required.
• Excellent analytical and problem-solving capabilities
• Possesses interpersonal skills to negotiate and reconcile differences, while optimizing overall business goals
• Excellent written and verbal communications skills with strong competency in MS Office tools and Project management applications.