Medical Device Test Engineer

About the Company

CorFlow is a Swiss med-tech start-up founded in 2016 by renowned interventional cardiologists and medical device entrepreneurs. The company recently completed a major financing round which enables the expansion of the clinical program and employee team. At CorFlow, we envision being the leader in diagnostic and therapeutic solutions for restoring healthy microvascular blood flow anywhere in the human body where a critical need exists. We are developing a medical device that assesses Microvascular Obstructions (MVO) in real-time during PCI and serves as a treatment platform while the patient is still in the cath lab. Our mission is rooted in scientific excellence and driven by compassion for the welfare of Acute Coronary Syndrome (ACS) patients. CorFlow's 1st generation device has been investigated in a First-in-Human multi-center European clinical trial, and CorFlow developed a 2nd generation device, which is currently used in clinical trials.

About the Role

We seek a Test Engineer to support verification and validation activities on our path to market approval and to reinforce our young, passionate and dynamic R&D team in Bern.

Responsibilities

• Develop and execute verification campaigns for product and system-level requirements
• Coordinate and review verification activities by external development and manufacturing partners
• Ensure compliance with internal and external standards for testing
• Support the design and conduct of validation studies to confirm user needs and intended use, including usability testing.
• Develop and validate new test methods, while continuously improving existing processes to meet evolving product requirements
• Collaborate with design engineers to ensure testability of design inputs and support R&D team in development activities
• Support risk management activities (ISO through testing and documentation
• Document results in accordance with ISO 13485, FDA QSR, EU MDR, and product specific applicable standards
• Participate in design reviews, usability testing, and regulatory audits.
• Contribute to the Design History File (DHF) and Technical Documentation.

Qualifications

• Bachelor's degree in biomedical, mechanical, electrical engineering or a related field
• Professional experience as a test engineer, verification engineer, system engineer or similar role, preferably in MedTech or other regulated industry

Required Skills

• Strong analytical mindset and problem-solving skills, with the ability to work independently
• Strong organizational skills and attention to detail
• Good communication and interpersonal skills
• Fluent English (both written and spoken)

Preferred Skills

• Experience in one or more of the following standards is a plus: IEC , IEC , IEC , ISO , IEC 62304

Pay range and compensation package

We offer a full-time contract with a competitive package and career opportunities in a pioneering start-up environment.

How to Apply

If you possess the required experience and qualifications and want the challenge of growing with our company, please submit your application including your latest resume, cover letter and/or a short personal video* (max 2 min) with your motivation. Lukas Bereuter | Head of product development | | *video download link preferred

Equal Opportunity Statement

Corflow Therapeutics AG is an equal employment opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. Employment and advancement opportunities are available to all individuals regardless of their race, color, national origin, religion, ancestry, citizenship status, sex, sexual orientation, gender identity or expression, age, marital status, family responsibilities, pregnancy, disability, or any other protected characteristic.

Note: This job description is intended to provide a general overview of the responsibilities and qualifications for this position. It is not an exhaustive list, and duties may evolve over time based on the needs of the organization.