Biomedical NPD Engineer - join a cutting-edge MedTech company in Dublin where you will play a key role in the end-to-end design, development & optimization of life-changing medical devices. Work alongside a dynamic cross-functional team to bring innovative products from concept to commercialization.

RESPONSIBILITIES:

Lead the entire product development lifecycle, from concept, design & prototyping to testing, validation & market launch—across both hardware and software components.
Collaborate closely with Operations, QA/RA, Technical Support & Commercial teams to ensure alignment, quality & compliance at every development stage.
Partner with Product Managers to define technical specifications and product strategies based on market and business needs.
Conduct feasibility studies and generate design inputs for new product initiatives.
Develop and integrate embedded systems, firmware & software to ensure smooth system functionality.
Perform risk assessments and contribute to essential regulatory documentation, including Design History Files (DHF) and technical files.
Optimize designs for scalability and manufacturability in coordination with manufacturing teams.
Manage development timelines while ensuring adherence to regulatory and quality standards.
Participate in design reviews, lead prototype testing, and provide hands-on technical support across the product lifecycle.
Identify, troubleshoot & resolve technical issues in both development and post-launch phases.

REQUIREMENTS:

Degree in Mechanical, Electrical, Biomedical Engineering, or a related discipline.
5+ years' experience in product development engineering, ideally within the medical device sector.
Strong understanding of design controls, regulatory pathways & industry standards (e.g., FDA, ISO 13485).
Hands-on expertise in product design, prototyping & testing.
Proficient in risk management (e.g., FMEA) and validation methodologies.
Excellent problem-solving, communication & cross-functional collaboration skills.
Detail-oriented and proactive, with a passion for continuous improvement.
Willing to travel internationally as required.

ADVANTAGEOUS:

Familiarity with FDA 21 CFR Part 820, ISO 13485, and ISO 14971.
Experience using PLM systems and working within structured development environments.
Knowledge of Six Sigma and Lean Manufacturing principles.
Demonstrated success in implementing product improvements and risk mitigation strategies.
Mentoring or team leadership experience.
Ability to thrive in a fast-paced, evolving MedTech environment.