Biocartis

About the Company

Biocartis is an innovative molecular diagnostics company committed to revolutionizing molecular testing with its unique proprietary IdyllaTM Platform. We provide next generation diagnostic solutions, aimed at improving clinical practice for the benefit of patients, clinicians, payers and the healthcare industry, with a focus in oncology. Today, Biocartis offers tests supporting melanoma, colorectal, lung, breast, thyroid, brain and blood cancer.

Biocartis is headquartered in Mechelen, Belgium.

Listed Jobs

Company Name

Biocartis

Job Title

System Architect

Job Description

**Job Title** System Architect **Role Summary** Lead the technical architecture of the OMPS Platform, with a primary focus on the hardware components of the Idylla system. Drive strategic roadmaps, ensure compliance with regulatory standards, align cross‑functional stakeholders, and manage risks to deliver a robust, reliable, and compliant platform. **Expectations** - Develop and maintain strategic hardware roadmaps, budgets, and timelines. - Lead architectural decision‑making and ensure alignment with software, QA/RA, product, and development teams. - Translate platform needs into high‑level requirements and oversee verification and validation. - Produce business cases for improvement projects and defend system architecture in audits. **Key Responsibilities** - Ensure Design History File (DHF) and related processes comply with ISO 13485, FDA 21 CFR 820, and internal SOPs. - Evaluate design options and conduct trade‑off analyses to optimize cost, performance, and risk. - Create and maintain system models to identify interdependencies and early risks. - Communicate and train stakeholders on existing and proposed system solutions. - Monitor hardware quality events, oversee improvement projects, and lead technical guidance. - Collaborate with Product Management and other stakeholders on future system direction. - Work with people managers and technical leads on resource allocation, budgets, and forecasting. **Required Skills** - Strong expertise in biomedical, electro‑mechanical, or mechanical engineering, physics, or related fields. - Proficiency in statistical and data analysis for engineering decisions. - Experience in regulated environments (ISO 13485, FDA 21 CFR 820) or equivalent (aerospace, automotive, defense). - Excellent written and spoken English (professional proficiency); Dutch an advantage. - Leadership and stakeholder‑management abilities, with the capacity to translate complex technical concepts into clear, actionable insights. **Required Education & Certifications** - Master’s degree or PhD in biomedical engineering, electro‑mechanical engineering, mechanical engineering, physics, or equivalent. - Minimum 12 years of experience in product or process development (or 8 years including PhD); expertise in system architecture, hardware design, and regulatory compliance. ---

Mechelen, Belgium

Hybrid

14-01-2026

Company Name

Biocartis

Job Title

Senior System Engineer

Job Description

**Job Title:** Senior System Engineer **Role Summary:** Lead the design, development, and continuous improvement of the Idylla system and its sub‑systems, ensuring seamless integration and interaction of instruments, consoles, cartridges, and assays. Drive problem‑solving across multidisciplinary teams, establish strategic roadmaps, and mentor technical staff. **Expectations:** - Minimum of 5 + years in product or process development. - Master’s degree in bio‑engineering, mechanical/electro‑mechanical engineering, physics, or equivalent experience. - Proven experience in regulated environments (ISO 13485, FDA 21 CFR 820; aerospace/automotive/defence acceptable). - Familiarity with statistical/data‑analysis tools (Spotfire, R, Python, Minitab, MATLAB). **Key Responsibilities:** 1. Conduct strategic planning for system and sub‑system development aligned with business requirements. 2. Define scope, problem domain, and communicate project objectives with stakeholders. 3. Prepare and document development scenarios, trade‑off analyses, and decision rationale. 4. Develop roadmaps, project plans, budgets, and timelines. 5. Lead and coordinate system implementation activities. 6. Mentor and coach junior engineers and cross‑functional teams. 7. Deliver training on technical domains. 8. Champion continuous improvement initiatives for system engineering practices. **Required Skills:** - System engineering, mechatronics (hardware & software), and process engineering. - Mechanical/physics of fluids, plastic moulding/welding, and reliability engineering. - Lean Six Sigma methodology. - Test automation experience. - Data and statistical analysis fluency (Spotfire, R, Python, Minitab, MATLAB). - Knowledge of quality and compliance standards for medical devices/IVD (ISO 13485, ISO 14971, FDA 21 CFR part 820). - Professional proficiency in English; Dutch is a plus. **Required Education & Certifications:** - Master’s degree in Bio‑Engineering, Mechanical/Electro‑Mechanical Engineering, Physics, or equivalent. - Certifications in Lean Six Sigma, Six Sigma Black/Green Belt, or related process improvement methods (preferred). - Valid knowledge or certification in ISO 13485 and FDA 21 CFR 820 compliance (preferred).

Mechelen, Belgium

Hybrid

Senior

04-02-2026

Company Name

Biocartis

Job Title

(Associate) Director, Global Customer Success

Job Description

**Job Title:** (Associate) Director, Global Customer Success **Role Summary:** Leads the design, implementation, and continuous improvement of global customer success operations—including service, support, field technical assistance, molecular application support, and billing—to ensure a consistent, high‑quality customer experience, drive product adoption, and enable scalable growth across regions. **Expactations:** - Own global customer engagement processes and SOPs. - Define and monitor KPIs, dashboards, and performance reviews. - Align operations with sales, product roadmap, and business objectives. - Lead resource and capacity planning, budgeting, and investment approvals. - Serve as escalation point for high‑impact issues and ensure regulatory compliance. - Provide people leadership, coaching, and succession planning for regional managers/team leads. **Key Responsibilities:** - Design and continuously improve global SOPs, escalation paths, and issue‑resolution workflows. - Manage case, complaint, and inquiry handling standards across all regions. - Establish and own global KPIs, service‑level targets, and operational dashboards. - Drive corrective actions and continuous‑improvement initiatives. - Partner with regional leadership for headcount, capability planning, and budget alignment. - Influence global customer experience strategy and service‑model evolution. - Oversee service revenue models, contracts, billing, and preventive‑maintenance programs. - Ensure compliance with ISO, medical‑device, and IVD regulations. - Lead and develop managers/team leads, set performance standards, and conduct reviews. **Required Skills:** - Strong operational leadership and process‑scaling expertise. - Proven ability to drive performance metrics and data‑driven decision making. - Excellent cross‑functional collaboration with sales, marketing, and product teams. - Experience managing complex technical support environments and global teams. - Skilled in resource planning, budgeting, and managing external service providers. - Solid understanding of service revenue models and billing structures. - Effective communication, escalation management, and stakeholder influence. - Familiarity with regulated environments (ISO, medical‑device/IVD). **Required Education & Certifications:** - Advanced degree (M.S., Ph.D., or equivalent) in life sciences, engineering, or related field preferred; equivalent experience considered. - 8–12+ years progressive experience in customer service/support/field service within molecular diagnostics or medical devices (mandatory). - Demonstrated leadership experience managing managers or team leads. - Experience in precision oncology or related diagnostics is a plus. - No specific certifications required, but regulatory compliance knowledge essential.

Mechelen, Belgium

Hybrid

25-02-2026