Senior Process Engineer

About Robeauté

Robeauté is redefining the future of neurosurgery with self-propelled microrobots designed to navigate the human brain with unprecedented precision. Our technology makes it possible to reach deep brain regions that were previously inaccessible, without invasive surgery.

We have developed microrobots capable of travelling inside the brain to collect biopsies, deliver cancer drugs, and implant electrodes for neurological treatments.

Since our founding in 2017, we have filed 50+ patents and successfully tested our technology in living animals, with human clinical trials targeted for 2026/2027. We recently raised €27M in Series A funding from Plural, Cherry Ventures, Kindred Ventures, and Brainlab, fueling our next phase of growth.

Role Overview

As our manufacturing activities scale, we are looking for a Senior Process Engineer to transform product concepts into robust, scalable, and compliant manufacturing solutions. The role is central to industrialization, ensuring a controlled and reliable transition from prototype to production in a highly regulated medtech environment.

Responsibilities

• Lead the definition, development, and validation of critical manufacturing processes—including sterilization, component and final cleaning, surface treatments (coating), and sterile barrier packaging—while also overseeing labelling activities as part of product release, traceability, and regulatory compliance.
• These processes will be developed and controlled through rigorous characterization and statistical analysis aligned with industry best practices.
• Acting at the interface between R&D, Quality, and Manufacturing, you will collaborate with cross-functional teams to industrialize products at scale.
• You will manage external suppliers associated with these processes and oversee laboratory operations supporting process development and validation.
• In a fast-paced startup environment, you will play a key role in structuring and scaling manufacturing and assembly activities, developing robust processes supported by validation strategies (including DoE, statistical analysis, and process capability).
• You will identify and control critical process parameters (CPP) and critical quality attributes (CQA), and ensure effective risk management throughout the product lifecycle.

Requirements

Technical Skills

• Strong expertise in the development, optimization, and industrialization of manufacturing processes, using structured approaches (e.g., 5M framework).
• Proven hands-on experience with critical medtech manufacturing processes, including:
  • Sterilization methods (EtO, gamma irradiation, steam), from development to validation and routine control
  • Sterile barrier packaging systems and associated validation (sealing, integrity, aging)
  • Cleaning and contamination control in support of biocompatibility and sterilization requirements
  • Surface treatments (coating) and their impact on product performance
• In-depth understanding of cleanroom environments (ISO classes), including contamination control strategies, environmental monitoring, and operational constraints for medical device manufacturing.
• Proficiency in process characterization and statistical analysis, including DoE, SPC, process capability (Cp/Cpk), and measurement system analysis (R&R), to ensure process robustness and reproducibility.
• Strong experience in process and equipment validation (IQ/OQ/PQ), including definition of validation strategies, development of test methods, and execution in compliance with regulatory expectations.
• Strong problem-solving skills using structured methodologies (e.g., root cause analysis, 5 Whys, Ishikawa, PDCA).
• Good understanding of Design for Manufacturing (DfM) and its application during product development and industrialization.
• Experience with material characterization, and its impact on process performance, sterilization compatibility, and product reliability.
• Familiarity with supplier qualification and management, particularly for outsourced critical processes (e.g., sterilization, packaging).
• Strong understanding of medical device regulatory frameworks, including ISO 13485, GMP, and expectations related to Class III devices and clinical readiness (process maturity, traceability, validation level).
• Experience in building and maintaining Device Master Records (DMR) and associated validation and manufacturing documentation.
• Ability to manage industrialization projects, including planning, prioritization, and cross-functional coordination

Soft Skills

• Strong analytical mindset with a high level of rigor in structuring, validating, and challenging technical approaches.
• Ability to solve complex, multidisciplinary problems using a pragmatic, data-driven, and solution-oriented approach.
• High level of ownership and autonomy, with the ability to operate effectively in a fast-paced and evolving environment.
• Proactive mindset, with the ability to anticipate risks, identify opportunities, and drive initiatives forward.
• Results-driven, with a focus on delivering robust, scalable, and compliant solutions.
• Strong collaboration skills, with the ability to work effectively across cross-functional teams (R&D, Quality, Manufacturing, Regulatory).
• Clear and structured communication, with the ability to convey complex technical topics to both technical and non-technical stakeholders.
• Excellent prioritization and organizational skills, with the ability to manage multiple high-impact topics simultaneously.
• Adaptability and resilience in a startup environment with shifting constraints and priorities.
• Technical leadership, with the ability to influence decisions, challenge assumptions, and align stakeholders around industrialization and process strategies

Education & Experience

• Master's degree in Engineering, Materials Science, Biomaterials, Biomedical Engineering, or a related field.
• Minimum of 10 years of experience in the medical device industry, with a strong focus on industrialization, manufacturing processes, or process development.
• Proven experience working on Class III medical devices or similarly high-risk, highly regulated products, with exposure to clinical-stage or commercial manufacturing environments.
• Strong background in cleanroom manufacturing environments, with a solid understanding of contamination control, operational constraints, and regulatory expectations.
• Demonstrated experience in developing and validating manufacturing processes for sterile and/or implantable medical devices, including readiness for clinical use.
• Experience in scaling products from prototype to production, in regulated environments requiring high levels of traceability, validation, and documentation

Benefits

A Mission That Matters

• Join a team developing life-changing technology. Our microrobots have the potential to impact over 1 billion patients with neurological conditions by enabling unprecedented access to the brain.

World-First Innovation

• Work on pioneering microrobotic systems for brain diagnosis and treatment—minimally invasive, with maximum clinical impact.

An Exceptional Team

• Collaborate with leading engineers, clinicians, and researchers at the forefront of medical robotics and neurotechnology.

Real Ownership

• Join a well-funded deep-tech startup backed by top-tier investors. Take ownership of your domain, influence key technical decisions, and grow with the company.

Additional Benefits

• Health insurance — 60% covered by the company
• Meal vouchers — €9.25/day, 60% covered
• Transportation — 50% of commuting costs covered