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.
* 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 Biomedical, Mechanical or Electrical Engineering, or a related discipline.
* 5+ years’ experience in product development engineering.
* Some experience in product development 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.
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