Process Development Engineer

Sigmar Recruitment; Galway; On-site; EUR 65,000 - 90,000; Full time

Benefits offered by this job

Hands-on role

Influence manufacturing processes

Salary and benefits on application

Job summary

Sigmar Recruitment is seeking a Process Development Engineer to support the development and implementation of manufacturing and assembly processes for a Galway-based medical device start-up. You will develop processes, design fixtures, and qualify equipment while coordinating with internal and external partners.

The role demands an experienced engineer who can work independently in a fast-paced start-up setting, maintaining quality and driving timely project outcomes.

Qualifications

• A primary or Master’s degree in polymer, mechanical, manufacturing, biomedical engineering or a related discipline.
• At least three years’ experience in medical device development.
• Experience in the fabrication and manufacture of catheter-based medical devices.
• Demonstrable new product introduction experience within the medical device industry, including:
• Fixture and equipment design and specification.
• Process and process equipment validation.
• Development of work instructions.
• Establishment of calibration and maintenance activities.
• Working knowledge of materials and process capabilities used in catheter-based medical devices.
• Experience working within an ISO 13485-compliant manufacturing environment.
• Knowledge of risk management tools, including process FMEA.
• Ability to use statistical techniques, Six Sigma principles and Minitab analysis to support manufacturing processes.
• Excellent written and verbal communication skills.
• Strong planning, organisation and project execution skills.
• A collaborative, self-directed and solutions-focused approach.

Responsibilities

• Develop manufacturing processes, materials and methods for medical devices, using both internal and external development partners.
• Design, specify, procure and qualify process fixtures and equipment.
• Develop work instructions and supporting documentation, including calibration and maintenance requirements.
• Plan and execute process characterisation and validation activities.
• Develop process FMEAs and other risk management documentation related to the device and its manufacture.
• Work closely with device development, product characterisation, Quality, suppliers and contract manufacturers.
• Apply structured problem-solving techniques and statistical methods to support data-driven decisions.
• Manage project tasks, deliverables and timelines to ensure deadlines are achieved.
• Maintain compliance with all applicable quality requirements and build quality into every stage of your work.

Skills

Project management

Statistical methods

Six Sigma

Minitab

Process validation

Risk management

Communication skills

Team collaboration

Problem-solving

Education

Bachelor's or Master's degree in polymer, mechanical, manufacturing, biomedical engineering or related field

Tools

Minitab

Job description

Process Development Engineer

About Your New Employer

• Join an innovative start-up medical device company developing a next-generation device in Galway.
• Work with an enthusiastic, multidisciplinary team based with the opportunity to contribute to a high-impact start-up environment.

About Your New Job

As a Process Development Engineer, you will support the development and implementation of manufacturing and assembly processes for the company.

You will:

• Develop manufacturing processes, materials and methods for medical devices, using both internal and external development partners.
• Design, specify, procure and qualify process fixtures and equipment.
• Develop work instructions and supporting documentation, including calibration and maintenance requirements.
• Plan and execute process characterisation and validation activities.
• Develop process FMEAs and other risk management documentation related to the device and its manufacture.
• Work closely with device development, product characterisation, Quality, suppliers and contract manufacturers.
• Apply structured problem-solving techniques and statistical methods to support data-driven decisions.
• Manage project tasks, deliverables and timelines to ensure deadlines are achieved.
• Maintain compliance with all applicable quality requirements and build quality into every stage of your work.

This is a hands-on role suited to an experienced engineer who can work independently, demonstrate persistence and resourcefulness, and contribute effectively within a fast-paced start-up environment.

What Skills You Need

• A primary or Master’s degree in polymer, mechanical, manufacturing, biomedical engineering or a related discipline.
• At least three years’ experience in medical device development.
• Experience in the fabrication and manufacture of catheter-based medical devices.
• Demonstrable new product introduction experience within the medical device industry, including:
• Fixture and equipment design and specification.
• Process and process equipment validation.
• Development of work instructions.
• Establishment of calibration and maintenance activities.
• Working knowledge of materials and process capabilities used in catheter-based medical devices.
• Experience working within an ISO 13485-compliant manufacturing environment.
• Knowledge of risk management tools, including process FMEA.
• Ability to use statistical techniques, Six Sigma principles and Minitab analysis to support manufacturing processes.
• Excellent written and verbal communication skills.
• Strong planning, organisation and project execution skills.
• A collaborative, self-directed and solutions-focused approach.

What’s on Offer

• A hands-on position within a growing, entrepreneurial medical device company
• The opportunity to influence manufacturing processes, supplier development and product realisation from an early stage.
• Salary and benefits: details available on application.