Process Engineer

Life Science Recruitment; Galway; On-site; EUR 40,000 - 60,000; Full time

Job summary

A leading medical device company located in Galway is seeking a Process Development Engineer to support the development and implementation of manufacturing processes for their innovative heart support device. The ideal candidate will have at least three years of medical device experience and a Master's Degree in a relevant engineering field. This role offers the chance to drive the development of cutting-edge technology in a dynamic startup environment.

Qualifications

• Minimum of three years of medical device development experience.
• Experience in fabrication and manufacture of catheter-based medical devices.
• Skills in new product introduction for medical devices.

Responsibilities

• Develop manufacturing processes and methods as part of the product development team.
• Design, specify, procure and qualify process fixtures and equipment.
• Execute process characterisation and validation activities.
• Provide technical guidance to other team members.

Skills

Medical device development experience

Process validation

Fixture design

Statistical analysis

Education

Master’s Degree in relevant engineering discipline

Job description

Job Title

Process Development Engineer

Location

Parkmore, Galway

Company

My client are a medical device company developing a new and innovative device to support the heart. Heart support devices are used by interventional cardiologists to stabilize patients in times of acute heart failure (cardiogenic shock) or patients undergoing high-risk coronary procedures (high-risk PCI). Their objective is to overcome the limitations of current assist devices by providing interventional cardiologists with a more effective and less invasive device. Founded in 2018 as a Radboud UMC spin-off. They are an enthusiastic team with diverse backgrounds and expertise located in the Netherlands and in Galway Ireland.

Job Description

Support the development and implementation of manufacturing and assembly processes associated with the company’s pVAD catheter, design feedback & input, as well as working with the suppliers of catheter components. The PD Engineer will work closely with his/her counterparts responsible for device development and characterization, other development functions, and Quality. They will share the responsibility of realising their full potential. The successful candidate will have entrepreneurial spirit, the required persistence and resourcefulness to succeed in a start-up environment, and the ability to work in a self-directed manner. They will have hands‑on knowledge and experience in both the development of cardiovascular devices and the processes required to manufacture them.

Responsibilities

• Develop manufacturing processes, materials, and methods as part of the product development team, using in‑house and external development path.
• Design, specify, procure and qualify process fixtures and equipment.
• Develop work instructions and other supporting documentation (e.g. calibration and maintenance) for manufacturing processes.
• Execute process characterisation and validation activities.
• Become a technical expert in the assembly and manufacture of our products, and provide technical guidance to other team members.
• Build quality into all aspects of work by maintaining compliance to all quality requirements.
• Work with internal cross‑functional teams and contract manufacturers or design firms to ensure system design, architecture, and verification/validation meets design input.
• Support cleanroom set‑up, fit‑out & validation (www.cardiacbooster.com).
• Evaluate relevant process & manufacturing technologies and strategically identify opportunities to implement them.
• Execute project plans, tasks and deliverables. Manage time to meet project deadlines.
• Use structured problem‑solving techniques and statistical methods for data‑driven analysis and decisions.

Required Qualifications

• Minimum of three years of medical device development experience, and a primary or Master’s Degree in a relevant engineering discipline such as polymer, mechanical, manufacturing or biomedical engineering.
• Experience in fabrication and manufacture of catheter based medical devices; experience in large calibre delivery systems is an advantage.
• Product and process development, and new product introduction skills in medical devices are a must. In particular:
  • Fixture and equipment design & specification
  • Validation of processes and process equipment
  • Development of work instructions and calibration & maintenance activities for manufacturing processes

Next Steps

Does this sound like your next career move? For more info forward your application or contact me on 087 0612325 or [e-mail].