Staff Process Engineer

Summary

We are seeking an experienced Staff Process Development Engineer to join our team in a critical role focused on designing, developing, and optimizing manufacturing processes for innovative medical devices. This position will drive compliance with industry regulations while further refining company methodologies to standardize and optimize steps for process characterization, development, and industrialization.

The ideal candidate will lead process improvements, manage technical projects, and mentor junior team members, contributing to the delivery of repeatable manufacturing processes and high-quality, efficient products.

Responsibilities:

• Enhance and standardize company approaches to process development.
• Benchmark and evaluate advanced technologies, materials, and methods to optimize manufacturing operations through research and networking with vendors and education centers.
• Scale up processes from pilot-scale to full-scale production, ensuring robustness and repeatability by directing internal teams and collaborating with customers.
• Lead the development and validation of new manufacturing processes from concept to production.
• Develop and maintain process documentation to meet regulatory requirements.
• Ensure compliance with quality standards, including risk management practices.
• Act as a technical liaison with suppliers to align material and component quality with process requirements.
• Drive continuous improvement initiatives to enhance process efficiency, reduce costs, and improve product quality.
• Apply Six Sigma, Lean Manufacturing, and other methodologies to optimize process performance.
• Monitor and analyze production data to identify and address process variances.
• Lead the optimization and implementation of a lean process development system within ICS Medical.
• Manage technical projects, including resource planning, timeline management, and risk assessment.
• Mentor junior engineers and technicians, fostering collaboration and innovation.
• Provide subject-matter expertise during audits and technical reviews.

Qualifications

• Bachelor’s degree in Engineering (e.g., Mechanical, Biomedical, or related field).

Required Experience:

• 8+ years of experience in process development within the medical device industry.
• Proven expertise in developing and scaling manufacturing processes in regulated environments.
• Hands-on experience with process validation (IQ, OQ, PQ) and statistical process control (SPC).

Skills

• In-depth knowledge of medical device regulations and standards (e.g., ISO 13485, FDA cGMP).
• Proficiency in data analysis tools and techniques (e.g., DOE, Minitab).
• Expertise in manufacturing technologies such as injection moulding, laser processing, automation, or additive manufacturing.
• Strong project management skills and experience leading cross-functional teams.
• Excellent verbal and written communication skills, including technical documentation.

Preferred

• Certification in Lean Six Sigma (Green Belt or Black Belt).
• Experience with Design for Manufacturability (DFM) and Design for Assembly (DFA).
• Familiarity with cleanroom operations and sterilization processes (e.g., EtO, gamma).

For further information on this role please contact Gavin Moran +353874108620 or email connect@hero.ie

Check out all our open jobs on our HERO Recruitment website – https://www.hero.ie/

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