Staff Design Engineer – Medical Devices

About the role

Implantica is seeking a Staff Design Engineer to lead the design and development of innovative implantable medical devices. The role will provide technical direction across multidisciplinary teams and drive product development from concept through commercialization, working remotely from Ireland.

Key responsibilities

• Lead design and development of medical devices using CAD tools such as SolidWorks, ensuring mechanical robustness and regulatory compliance.
• Draft detailed mechanical component and assembly designs with GD&T to support precision manufacturing.
• Develop and execute comprehensive test plans, including experimental design, statistical analysis, and reporting for pre‑clinical and external laboratory testing.
• Conceptualize, develop, and validate test methods for design verification and regulatory submissions.
• Drive component qualification and creation of design documentation (specifications, drawings, risk analyses, traceability matrices) in line with quality system requirements.
• Collaborate with R&D, Manufacturing, Regulatory, Quality, and Clinical teams to resolve technical issues and support sustaining engineering.

Required profile

• Bachelor’s degree in Mechanical or Biomedical Engineering or equivalent experience.
• Minimum 7 years of experience in medical device engineering or manufacturing, including work with US Class III or EU Class IIb devices.
• Experience with active implantable devices; stainless‑steel machining or polymer injection molding is preferred.
• Strong knowledge of 21 CFR 820, FDA device approvals (PMAs), ISO 13485, ISO 14971, IEC 62366 and MDSAP requirements.
• Proven ability to conduct failure investigations, root‑cause analysis, and risk assessments (FMECAs).
• Excellent written and verbal communication skills in English, with experience preparing protocols, test plans, and design‑control documentation.

Required skills

• SolidWorks (3D CAD) and other CAD software.
• Geometric Dimensioning & Tolerancing (GD&T).
• Minitab and statistical analysis tools.
• Microsoft Office suite.
• Knowledge of US and EU regulatory standards (21 CFR 820, ISO 13485, etc.).
• Experience with stainless‑steel machining and polymer injection molding processes.