Principal Product Development & Manufacturing Engineer

SymPhysis Medical; Galway; Hybrid; EUR 120,000 - 180,000; Full time

Benefits offered by this job

Flexible working hours

State-of-the-art innovation hub

Competitive salary & benefits

Job summary

SymPhysis Medical in Galway seeks a Principal Product Development & Manufacturing Engineer to drive the integration of product development with manufacturing. You will lead design control activities, manage supplier relationships, and ensure robust development builds align with production readiness in a fast-moving, FDA-focused environment.

You will collaborate with cross-functional teams to enable scalable, compliant product launches, advancing medical device programs from concept through to

Qualifications

• Engineering degree in Mechanical or Biomedical field is required.
• Significant experience with ISO 13485 and EU/US medical device regulations.
• Proven experience supporting manufacturing and working with external suppliers.
• Strong knowledge of design control, risk management and change control processes.

Responsibilities

• Act as the primary R&D interface to manufacturing.
• Lead manufacturing reviews and ensure design for manufacturability principles are applied.
• Lead OQ and PQ activities.
• Investigate and resolve manufacturing issues.
• Own build trackers and ensure alignment between development builds and production readiness.
• Provide technical oversight of key suppliers in collaboration with Quality.
• Support supplier selection, qualification and performance monitoring.
• Act as escalation point for complex supplier-related technical issues.

Skills

Problem-solving

Stakeholder management

Project management

Communication

Education

Bachelor's or Master's degree in Mechanical or Biomedical Engineering

Job description

SymPhysis Medical in Galway seeks a Principal Product Development & Manufacturing Engineer to drive the integration of product development with manufacturing. You will lead design control activities, manage supplier relationships, and ensure robust development builds align with production readiness in a fast-moving, FDA-focused environment.

You will collaborate with cross-functional teams to enable scalable, compliant product launches, advancing medical device programs from concept through to