Senior Medical Product Developer

7 days ago

Limerick, Limerick, Ireland beBeeProductDevelopment Full time €73,500 - €125,000

Job Overview

Our company is seeking a highly skilled and experienced Technical Project Manager to lead the development of innovative medical products. This role combines technical leadership, systems engineering, and regulatory compliance responsibilities, guiding cross-functional teams through the full product lifecycle from concept development to commercialization and post-market support.

You will play a pivotal role in shaping product architecture, defining system and sub-system requirements, ensuring traceability and documentation for regulatory submissions, and mentoring team members. This is a unique opportunity to influence the development of life-changing healthcare solutions in a regulated environment.

We prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry.

Key Responsibilities

  • System Design & Development: Lead system-level design and development for new and existing medical products, ensuring alignment with stakeholder needs.
  • Requirements & Architecture: Define product architectures and translate stakeholder inputs into clear, traceable system requirements.
  • Integration & Testing: Oversee system integration and testing activities, supporting verification and validation across hardware, software, UX, and systems.
  • Technical Leadership: Provide mentorship and technical guidance to cross-functional teams, promoting engineering excellence.
  • Documentation & Tools: Own and maintain design control documentation, SOPs, and requirements using tools like DOORS and Modern Requirements.
  • Regulatory Compliance: Ensure compliance with ISO 13485, ISO 14971, FDA QSR, and support FDA submissions through collaboration with quality and regulatory teams.
  • Risk Management: Conduct risk assessments and implement mitigation strategies, contributing to activities like dFMEA and hazard analysis.
  • Multi-functional Collaboration: Work closely with Engineering, Quality, Regulatory, Manufacturing, and Marketing to ensure smooth project execution and post-market support.

Required Skills & Qualifications

  • Proven experience in leading technical project teams (HW, SW, UX, Systems) through the product lifecycle and phase-gate approach.
  • Strong ability to lead large teams and communicate technical deliverables effectively.
  • Experience in writing SOPs, guidance, and technical documentation.
  • Proficiency in Microsoft Project, Excel, especially in writing macros.
  • Experience in cross-functional product development.

Preferred Qualifications

  • Bachelor's or Master's degree in Engineering, Systems Engineering, Biomedical Engineering, or related field.
  • 5+ years of progressive experience as a senior/lead engineer in product development.
  • Creative problem solver with the ability to resolve conflicting requirements and technical risks.
  • Practical experience in configuration management and change control processes.
  • Familiarity with tools like DOORS, Modern Requirements, SolidWorks, MATLAB, LabVIEW, Minitab.

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