Systems Engineer (Systems Engineering)

Job title:

Systems Engineer (Systems Engineering)

Company:

Capax Recruitment

Job description

This role is based in Allerød.About UNEEG MedicalUNEEG medical A/S is a dynamic and pioneering company in the field of medical technology. The company is committed to improving the quality of life for epilepsy patients through innovative solutions that revolutionize epilepsy treatment.UNEEG medical’s mission is to enable continuous measurement and collection of EEG data 24/7, providing patients and healthcare professionals with deeper insights into the brain. These insights can enhance patient care by optimizing the treatment and management of epileptic seizures. UNEEG medical is at the forefront of cognitive technologies for monitoring and analyzing EEG data, with a strong presence in the European market and preparations for expansion into the USA.With headquarters in Allerød, Denmark, UNEEG medical employs around 70 dedicated professionals across Europe. As part of this family-owned company, you’ll have the opportunity to contribute to the development and marketing of groundbreaking solutions for epilepsy patients while being part of a unique and innovative culture. About the departmentAs a Systems Engineer at UNEEG, you will be part of the Systems Engineering team, focusing on product-level engineering. The team consists of three Systems Engineers, and you will play a key role in driving decisions and developments within the department. You will collaborate with various internal stakeholders, including regulatory affairs, software/hardware engineers, project managers, and clinical affairs. The role is truly cross-functional, and you will be involved in multiple projects while contributing to the team’s efforts to achieve FDA approval and expand into the U.S. market. Your structured, holistic mindset will be key to maintaining high standards and well-organized processes. About the positionUNEEG medical is looking for a Systems Engineer to take a broad, central role in medical device projects at the product level. Depending on your specific competencies, you will be responsible for various aspects of the product development process, such as creating key product documentation, including design inputs/outputs, verification plans, design validation, and risk management files. The Systems Engineering team is responsible for the design control process, and you will support internal stakeholders in applying these principles effectively. This role offers an exciting opportunity to work across multiple product lines and contribute to both the development and maintenance of cutting-edge medical technology solutions. Responsibilities

• Product Documentation: Develop and manage product documentation such as design input/outputs, verification and validation plans, tests, and risk management files.
• Design Control: Ensure compliance with design control processes while supporting internal stakeholders in adhering to these principles throughout product development.
• FDA Approval: Play a key role in the effort to obtain FDA approval for UNEEG’s systems. Ensure that the necessary documentation, tests, usability tests, and protocols are in place to meet FDA requirements.
• Cross-Functional Collaboration: Collaborate closely with internal teams, supporting product development and ensuring that the systems meet both technical and regulatory requirements.
• Continuous Improvement: Contribute to maintaining and improving existing systems to ensure that UNEEG’s solutions remain at the forefront of medical technology.

Qualifications

• Proven experience in systems engineering within the medical device industry.
• Strong understanding of medical device lifecycle management and technical documentation.
• Familiarity with creating and managing product documentation such as design inputs/outputs, verification and validation plans, and risk management files.
• Experience in working towards FDA approval and understanding the necessary processes and requirements.
• Ability to support internal stakeholders in applying design control principles effectively.
• A collaborative, proactive mindset with a focus on finding practical solutions to technical challenges.

Are you ready to join a pioneering company that is transforming epilepsy treatment and improving patient care? Join the UNEEG TeamIf you are interested in this opportunity and to contribute to the development of cutting-edge medical technology and make an impact in the lives of epilepsy patients, UNEEG medical offers a dynamic and supportive environment for you to thrive.Apply today to take the next step in your career as a Systems Engineer at UNEEG medical.Capax Recruitment is assisting UNEEG Medical in this recruitment. For further information please contact Vjollca Muaremi vmu@capax.dk.

Expected salary

Location

Lillerød, Hovedstaden

Job date

Sat, 21 Dec 2024 23:57:11 GMT

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