Job Overview:

We are seeking a highly skilled Senior R&D Engineer to join our innovative team. The ideal candidate will be responsible for leading the design and development of new medical devices, from initial concept through to commercialization. This role involves significant interaction with cross-functional teams, including Key Opinion Leaders (KOLs), physicians, and product managers, to ensure that all products meet clinical and design requirements while complying with industry regulations.

Key Responsibilities:

• Design and Development: Lead the design, development, prototyping, and testing of new medical devices. This includes creating design specifications, conducting design evaluations, and managing design reviews.
• Verification and Validation: Develop and execute design verification and validation protocols, ensuring compliance with industry standards and regulatory requirements.
• Production Transfer: Manage the transfer of designs to production, ensuring that products are manufactured in a timely and effective manner.
• Risk Management: Conduct product and project risk analysis, implementing risk management strategies to mitigate potential issues.
• Prototyping: Develop prototypes that align with the clinical and design objectives of each project.
• Research and Innovation: Research new therapies and design solutions to enhance and expand the existing product portfolio. Introduce new equipment, materials, and technologies to the development process.
• Collaboration: Work closely with Key Opinion Leaders (KOLs), physicians, and product managers to develop innovative solutions that improve patient care.
• Project Leadership: Serve as the project lead for assigned R&D teams, providing both technical and project management leadership. Drive project tasks to ensure timely completion of milestones and achievement of business objectives.
• Design Decision-Making: Lead all key design decisions to ensure the selection of quality designs that meet project requirements.
• Team Management: Manage and mentor the project team, fostering innovation and creativity while ensuring adherence to company policies and quality systems.
• Compliance: Ensure all activities comply with Quality, Regulatory, and company policies, including ISO13485 and FDA CFR 820 regulations.
• Communication: Regularly communicate project status, milestones, and risks to cross-functional teams, senior management, and business unit leaders.
• Change Management: Drive and implement changes aimed at improving departmental and company performance.
• Cross-Functional Support: Collaborate with other cross-functional teams to support the achievement of company goals.

Qualifications / Requirements:

• Educational Background: Bachelor’s degree in Mechanical, Biomedical, Science, Design, or a similar discipline. A Master’s or Ph.D. is preferred but not essential.
• Experience: Ideally, 5+ years of experience in medical device development, from concept through to commercialization.
• Project Leadership: Proven ability to lead projects, with strong project management skills and a track record of delivering quality results on time.
• Mechanical Design: Strong mechanical design skills and understanding of engineering fundamentals, with extensive knowledge of medical device materials.
• Manufacturing Knowledge: Good understanding of manufacturing design and processes, particularly within the medical device industry.
• CAD Proficiency: Proficient in SolidWorks and/or Pro Engineer CAD software.
• Communication Skills: Strong presentation skills and technical writing abilities, with working knowledge of MS PowerPoint.
• Attention to Detail: High attention to detail with a strong focus on quality and compliance.
• Regulatory Knowledge: Good working knowledge of medical device quality and regulatory systems, including ISO13485 and FDA CFR 820.
• Adaptability: Ability to work effectively in a fast-paced environment.
• Clinician Collaboration: Experience in translating clinician needs into project inputs.
• Travel: Willingness and availability to travel for company business as required

For more information on this role in please contact Johanne Kennedy on +353 86 440 3725 / choices@hero.ie

Check out all our open jobs on our HERO Recruitment website – https://www.hero.ie/

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