Product Development Engineer

HIQA - Health Information and Quality Authority; Connacht; On-site; EUR 40,000 - 60,000; Full time

Job summary

A leading medical device manufacturing company in Galway is seeking a Product Development Engineer for a 12-month contract. The role involves leading product development from concept to commercialization, ensuring compliance with regulations, and collaborating with cross-functional teams. Ideal candidates will have a degree in engineering and relevant industry experience.

Qualifications

• 3-5 years’ work experience in medical device or similar industry.
• Demonstrated ability to develop medical devices from concept to commercialization.
• Familiar with medical device regulations FDA, QSR and ISO 13485.

Responsibilities

• Lead product and process development activities from concept to commercialization.
• Develop new concepts, prototypes and products following the company’s PDP procedure.
• Maintain detailed documentation throughout all project phases.

Skills

Communication

Problem Solving

Analytical Skills

Education

Degree in Mechanical Engineering

Degree in Biomedical Engineering

Degree in Polymer Engineering

Job description

ID Recruitment are working with a Medical Device manufacturing company in Galway to recruit a Product Development Engineer for a 12-month contract.

The Product Development Engineer will participate as a team member in the product development process from concept to commercialization of novel medical devices. You will act as a technical leader for projects and may be assigned engineers, technician, interns or operators to supervise and/or provide guidance. You will have the opportunity to work in a dynamic and collaborative environment.

The role will offer an attractive salary and benefits.

Duties include;

• Contributor on PDP projects leading product and process development activities from concept to commercialization.
• Develop new concepts, prototypes and products from concept to commercialization following the company’s PDP procedure meeting or exceeding customer requirements
• Partner with Program Managers to generate project plans and execute the project plan to schedule, within budget constraints, meeting customer requirements
• Develop innovative concepts for new devices and processes that satisfy customer and regulatory requirements
• Participate in brainstorming and troubleshooting activities
• Participate in design reviews to support advancement of projects from concept to commercialization following the company’s PDP procedure
• Participate in design for manufacture/design for assembly activities
• Participate in the organization and execution of interdepartmental activities to ensure advancement of projects from concept to commercialization following company procedures
• Maintains detailed documentation throughout all project phases
• Participate in design and process verification and validation activities working with manufacturing and quality personnel
• Work with other sites to support design and development activities
• Participate in customer meetings and visits
• Familiar with medical device regulations FDA, QSR and ISO 13485

Skills and Qualifications:

• Degree in mechanical engineering, biomedical engineering, polymer engineering or other equivalent discipline
• 3-5 years’ work experience in medical device or similar industry
• Demonstrated ability to develop medical devices from concept to commercialization
• Experience in design and manufacture of balloon catheters and delivery systems
• Experience in phase-gated, PDP (Product Development Process) procedure
• Familiar with DFM/DFA principles
• Strong communication and presentation skills
• Strong problem solving and analytical skills