Medical Device Product Development Lead: From Concept to Commercialization

Zohorecruit; Galway; On-site; EUR 90,000 - 120,000; Full time

Job summary

IDRecruitment is recruiting a Product Development Engineering Manager for a medical device company based in Galway. The role leads a team to move projects from Phase 1 to commercialization, acting as a technical leader for PDP processes and training related to PDP procedures.

The successful candidate will ensure design-for-manufacture, process validation, and robust documentation, coordinating with manufacturing and quality teams to meet regulatory requirements and deliver high-quality medical

Qualifications

• Degree in mechanical engineering, biomedical engineering, polymer engineering or other equivalent discipline.
• 10+ years’ work experience in medical device or similar industry is preferred.
• Demonstrated ability to develop medical devices from concept to commercialization.
• Experience in design and manufacture of balloon catheters and delivery systems.
• Familiar with DFM/DFA principles.
• Strong communication and presentation skills.
• Strong problem solving and analysis skills.

Responsibilities

• Partner with Program Managers to execute project plans to schedule and within budget, meeting customer requirements.
• Collaborate with Manufacturing Engineering, NPI Engineering, or SMEs to develop manufacturing processes following lean principles and DFM to satisfy requirements and regulatory needs.
• Mentor and develop junior staff on PDP overview, procedure, and best practices.
• Mentor and develop juniors to lead projects or portions of larger programs.
• Coordinate and participate in brainstorming and troubleshooting activities.
• Support design for manufacture/assembly during project progression from Phase 1 to commercialization.
• Maintain detailed documentation throughout all project phases.
• Engage in design verification/validation with manufacturing and quality teams.
• Work with other sites to support design and development activities.
• Participate in customer meetings and visits.
• Familiar with FDA, QSR and ISO 13485 regulations.

Skills

Project management

Team leadership

Regulatory awareness

DFM/DFA

Strong communication

Problem solving

Education

Bachelor's degree in mechanical engineering

10+ years experience in medical devices

Tools

SolidWorks

Job description

IDRecruitment is recruiting a Product Development Engineering Manager for a medical device company based in Galway. The role leads a team to move projects from Phase 1 to commercialization, acting as a technical leader for PDP processes and training related to PDP procedures.

The successful candidate will ensure design-for-manufacture, process validation, and robust documentation, coordinating with manufacturing and quality teams to meet regulatory requirements and deliver high-quality medical