Staff Design Engineer

About Implantica

Implantica is a medtech innovator committed to developing advanced implantable technologies aimed at improving patient quality of life and clinical outcomes. Their flagship product, RefluxStop, is a CE-certified implant treating gastroesophageal reflux disease (GERD) and has the potential to revolutionize the anti-reflux surgical standard of care. The company has a diverse patented portfolio encompassing an eHealth platform for remote implant monitoring and a wireless power technology enabling control of implants through intact skin. Implantica is publicly traded on NASDAQ First North Premier Growth Market.

Role Overview

The Staff Design Engineer will lead the conceptualization and engineering of implantable medical devices, providing technical guidance across multidisciplinary teams and steering projects from initial design stages through market release. This role allows remote work from Ireland, with optional company-supported relocation to Switzerland or Malta.

Key Responsibilities

• Lead mechanical design efforts using CAD platforms such as SolidWorks, ensuring device durability and compliance with relevant medical industry standards.
• Create detailed mechanical part and assembly blueprints incorporating GD&T to facilitate precision manufacturing and assembly processes.
• Develop and implement comprehensive testing strategies, including experimental design and statistical analysis, to validate design robustness and guarantee regulatory compliance. This involves internal pre-clinical testing and coordination with third-party labs for packaging, transport, shelf-life, sterilization, reprocessing, and biocompatibility evaluations.
• Innovate and validate test methodologies supporting design validation and regulatory submissions.
• Lead development teams in component qualification and documentation creation such as Design Specifications, drawings, risk analyses, and Trace Matrices, aligned with quality system and design control standards.
• Prepare documents and apply statistical methods to plan and execute V&V activities per regulatory requirements, specifically US FDA Code of Federal Regulations including 21 CFR 820.75.
• Collaborate cross-functionally with R&D, Manufacturing, Regulatory, Quality, and Clinical teams to troubleshoot complex technical challenges, support ongoing engineering efforts, and maintain post-market product safety and performance.
• Provide expert technical guidance and maintain effective communications with senior leadership, peers, team members, and external stakeholders to ensure project success.
• Perform detailed failure investigations, root cause analyses, and risk assessments (FMECAs) to identify hazards and implement mitigation strategies within design, usage, and processes.

Candidate Profile

• Bachelor's degree in Mechanical or Biomedical Engineering or equivalent experience.
• Minimum of 7 years of demonstrated medical device design and manufacturing experience.
• Experience working with US Class III and/or EU Class IIb medical devices is mandatory; prior involvement with active implantables is highly desirable.
• Familiarity with stainless steel machining and injection molding of polymers preferred.
• Strong knowledge of regulatory standards including 21 CFR 820, FDA device approval processes (especially PMA), ISO 13485, ISO 14971, IEC 62366, FDA guidelines on process validation, and statistical procedures such as STAT-09.
• Good understanding of Medical Device Single Audit Program (MDSAP) requirements.
• Exceptional attention to detail and ability to multitask under pressure.
• Skilled in collaborating across global teams and locations with effective prioritization capabilities.
• Proficient in English with strong written and verbal communication skills; experience drafting protocols, test plans, reports, and documents to meet design control regulations.
• Advanced knowledge of Microsoft Office, Minitab, charting software, and SolidWorks is essential.
• Willingness and ability to travel internationally as required.