Staff Design Engineer

Implantica

Implantica is a medtech company focused on bringing advanced implantable technology into the body to improve patient outcomes and quality of life. Implantica’s lead product, RefluxStop, is a CE-marked implant for the treatment of gastroesophageal reflux disease (GERD) with the potential to transform the standard of care in anti-reflux surgery, supported by strong long-term clinical outcomes. Implantica has developed a broad, patent-protected product pipeline incorporating an eHealth platform designed to enable communication and remote monitoring of implants inside the body, and a wireless energizing platform designed to power remote-controlled implants wirelessly through intact skin. Implantica is listed on NASDAQ First North Premier Growth Market.

The Role:

We are seeking a Staff Design Engineer responsible for leading the design and development of innovative implantable medical devices, providing technical direction across multidisciplinary teams, and driving product development from concept through commercialization.This position will provide you the opportunity to work in a multinational environment with the role remote-based work in Ireland. Company-sponsored relocation to Switzerland or Malta can be considered, if desired.

Key Responsibilities & Tasks:

• Lead the design and development of medical devices using CAD software such as SolidWorks and other 3D modeling tools, ensuring mechanical robustness and compliance with industry standards.

• Draft detailed mechanical component and assembly designs, including the use of GD&T (Geometric Dimensioning and Tolerancing), to ensure precision manufacturing and assembly.

• Lead the development and execution of rigorous testing approaches on projects by drafting comprehensive test plans (i.e. experimental design, statistical analyses) and detailed reports (i.e. data analysis, interpretation) that meet engineering objectives as well as ensure design robustness and regulatory compliance. This includes both internal pre-clinical testing as well as testing by external laboratories, including the packaging, transportation, shelf-life, reprocessing, sterilization, and biocompatibility testing by external service providers.

• Conceptualize, develop, and validate test methods in support of design and development efforts as well as regulatory submissions.

• Drive development teams to support component qualification and the development of product development documents (i.e. Design Specifications, drawings, risk documents, Trace Matrix, etc.), ensuring alignment with quality system requirements and design control standards.

• Preparation of documentation and use of statistical techniques, as necessary, to properly design and execute V&V activities, with focus on the US Code of Federal Regulations (CFR) and guidelines, such as 21 CFR 820.75.

• Collaborate closely with other R&D staff as well as Manufacturing, Regulatory, Quality, and Clinical teams to resolve complex technical issues, support sustaining engineering activities, and ensure continued product performance and safety in the field.

• Provide technical direction and interact professionally and effectively with senior management, peers, team members, supervisors, outside customers, and other teams/ departments on an ongoing basis to ensure product development success.

• Conduct thorough failure investigations, root cause analyses, and technical risk assessments to identify hazards and implement effective mitigations within Design, Use, and Process FMECAs.

Your Profile:

• Bachelor’s degree in Engineering Discipline (Mechanical / Biomedical, preferred) or equivalent experience.

• 7+ years demonstrated experience in medical device engineering or manufacturing.

• Experience with US Class III devices and/or EU Class IIb devices required. Active implantable experience highly desired.

• Experience with stainless steel machining and/or injection molding polymers preferred.

• In-depth knowledge of the following: 21 CFR 820 and FDA Device Approvals and Clearances preferably PMAs, ISO 13485, ISO 14971, IEC 62366, FDA Guidelines on general principles of process validation, 1987, STAT-09 Statistical procedures, etc.

• Good working knowledge on MDSAP requirements.

• Demonstrates strong attention to detail.

• Ability to work collaboratively across the organization with both internal and external teams and across different locations / time zones.

• Ability to effectively prioritize and execute tasks in a high-pressure environment

• Proficient with written and spoken English; strong written and verbal communication skills. Experience writing protocols, test plans, test reports, and design control regulation required.

• Detail oriented and the ability to manage multiple activities simultaneously.

• Expertise in Microsoft Office applications, Minitab, and charting programs. SolidWorks expertise required.

• Ability to travel internationally, as needed.