R&D Engineer (interim)

STENTiT is a medical device startup based at the High Tech Campus in Eindhoven, Netherlands, with the aim is to help people suffering from cardiovascular issues. We develop a novel class of regenerative endovascular implants for the treatment of cardiovascular diseases. Our ultimate goal is to restore the affected blood vessel from the inside out to provide a lifelong solution

Now we are looking for an Interim Research Engineer at our Eindhoven headquarters.

This is a unique opportunity for an ambitious, multi-talented individual who wants to see the inside of a fast-moving startup and shape the development of this first-of-a-kind medical device.

You will get insights into a unique company that has the vision to become one of the world's leading players in regenerative endovascular implants.

The position is intended for a duration of 6 months.

Product Development and Innovation:

• Conceptualize, design, and develop new endovascular implants and stents.
• Utilize advanced engineering principles to innovate and optimize product designs.
• Lead feasibility studies to assess the potential of new concepts and technologies.
• Collaborate with clinical team and other stakeholders to support identifying unmet needs and translate them into technical requirements.
• Drive the generation of new IP by identifying and capturing innovative ideas and developments within the R&D team.
• Collaborate with legal and patent professionals to secure patents and other forms of IP protection for key innovations.

Laboratory Work:

• Conduct experiments and tests under controlled laboratory conditions to validate design concepts and ensure product safety and efficacy.
• Operate and maintain specialized lab (including cleaning), equipment and instruments.
• Develop and execute test protocols, ensuring accurate and reliable data collection.

Documentation and Reporting:

• Prepare detailed technical documentation, including requirements, test protocols, work instructions (WIs) and standard operating procedures (SOPs).
• Write comprehensive reports summarizing experimental findings, analysis, and conclusions.
• Ensure all documentation meets regulatory and quality management system (QMS) standards.

Regulatory and Quality Compliance:

• Work closely with the regulatory team to ensure that all product development activities comply with relevant medical device regulations (e.g., FDA, ISO standards).
• Participate in risk management activities, including Failure Modes and Effects Analysis (FMEA) and design reviews.
• Support the preparation of regulatory submissions by providing technical expertise and documentation.

Project Management:

• Support in planning and managing R&D projects, including timelines, resources, and budgets.
• Coordinate with cross-functional teams, including manufacturing, quality assurance, and regulatory affairs, to ensure smooth project progression.
• Report project status to senior management and stakeholders, highlighting key milestones and potential risks.

Continuous Improvement:

• Stay up-to-date with the latest advancements in medical device technology, materials science, and relevant engineering disciplines.
• Identify opportunities for process improvements in the R&D department to enhance efficiency and product quality. Mentor and guide junior engineers and interns, fostering a culture of innovation and continuous learning.

Educational Background:

• Bachelor's or Master's degree in Biomedical Engineering, Mechanical Engineering, or a related field.
• Advanced knowledge of materials science, fluid dynamics, and biomechanics as they relate to medical devices is a plus.

Experience:

• Minimum of 3-5 years of experience in R&D within the medical device industry, preferably with a focus on endovascular implants or stents.
• Proven track record of successful product development from concept to market is a benefit.

Technical Skills:

• Experience with laboratory techniques and equipment used in medical device testing (e.g., tensile testers, microscopy).
• Familiarity with regulatory requirements (e.g., FDA 21 CFR Part 820, ISO 13485) and the ability to interpret and apply these to product development.
• Experience in stent development or detailed know-how in polymer chemistry is a plus.

Soft Skills:

• Strong analytical and problem-solving abilities, with a detail-oriented approach to engineering challenges.
• Excellent written and verbal communication skills, with the ability to convey complex technical concepts to non-technical stakeholders.
• Ability to work both independently and as part of a multidisciplinary team.

Additional Qualifications:

• Experience with risk management techniques and regulatory submissions is highly desirable.
• Certification in project management (e.g., PMP) is a plus.

• Great opportunities for personal and professional growth in a committed, innovative and dynamic team.
• Challenging and varied tasks in an innovative environment with real impact.
• Experience entrepreneurship first hand.
• Rare opportunity to actively shape the development of a first-of-a-kind medical product to safe patient lives.

Sounds interesting? We look forward to meeting you. Submit your CV and all relevant working documents online now!