Process Development Engineer II

Location: Galway, Ireland

Industry: Medical Devices

Reports To: Process Development Manager

Job Summary:

We are seeking a Process Development Engineer II to support the Product Development Process (PDP) for the successful introduction of a new medical device product at our Galway site. The successful candidate will play a key role in developing, qualifying, and validating manufacturing processes to ensure smooth transition from concept to commercial production.

Key Responsibilities:

• Support all phases of the Product Development Process (PDP) for new product introductions.
• Lead and execute equipment selection, development, and qualification activities in collaboration with internal and external stakeholders.
• Develop and validate robust and repeatable test methods in line with regulatory and quality standards.
• Plan and execute process characterization studies (e.g., DOE, Gage R&R, Capability Analysis).
• Lead Process Validation (IQ/OQ/PQ) efforts to ensure compliance with GMP and FDA requirements.
• Drive continuous improvement initiatives to optimize manufacturing processes and improve product quality.
• Collaborate cross-functionally with R&D, Quality, Regulatory, and Operations teams.
• Prepare and maintain technical documentation including protocols, reports, and engineering change orders.
• Ensure alignment with design for manufacturability (DFM) principles throughout development stages.

Requirements:

Education & Experience:

• Bachelor’s degree in Mechanical, Biomedical, Manufacturing, or related engineering discipline.
• Minimum 3–5 years of relevant experience in medical device manufacturing or product/process development.
• Previous experience with PDP and new product introduction (NPI) is highly desirable.

Technical Skills:

• Strong working knowledge of equipment qualification, test method validation, and process validation.
• Familiarity with medical device regulatory standards (FDA, ISO 13485, GMP).
• Proficient in statistical tools for process characterization and validation (e.g., Minitab, JMP).
• Hands-on experience with root cause analysis, FMEA, and problem-solving methodologies.

Soft Skills:

• Excellent project management, communication, and interpersonal skills.
• Self-starter with a strong sense of ownership and accountability.
• Ability to thrive in a fast-paced, cross-functional team environment.

Desirable:

• Experience with cleanroom manufacturing environments.
• Familiarity with Six Sigma or Lean Manufacturing methodologies.
• Advanced degree or certifications (e.g., Six Sigma Green/Black Belt) is a plus.