Medical Device Software Specialist

BSI; Madrid; Presencial; EUR 50.000 - 70.000; Jornada completa

Descripción de la vacante

A leading global certification body is seeking a Technical Specialist to manage CE marking schemes for medical device software. You will deliver technical documentation assessments and support medical device manufacturers globally. Candidates should have at least 4 years of Software Medical Device experience and a relevant bachelor's degree. This role offers competitive pay and opportunities for professional growth.

Servicios

Competitive salary

Ample annual leave

Professional development opportunities

Formación

• 4 or more years of Software Medical Device experience in a technical capacity, preferably in product design, development, or testing.
• Understanding of International and National standards for software medical devices design, development, and regulation.
• Broad technical understanding of medical devices and current industry trends.

Responsabilidades

• Plan and deliver Technical File Assessments and Design Examinations.
• Manage client projects and make certification recommendations.
• Provide technical support to the commercial team.

Conocimientos

Software Medical Device experience

Understanding of software regulatory standards

Knowledge of Risk Management and FMEA

Educación

Bachelor’s degree in relevant fields

Descripción del empleo

Great that you're thinking about a career with BSI!

Job Title :

Technical Specialist, Scheme Manager, Clinical Evaluation Specialist - SaMD

Reports to :

Technical Team Manager

Location :

Home Based – Global

We have exciting opportunities for medical device software specialists to join our Software team. You will have the opportunity to work with medical device manufacturers across the globe, from dynamic start-ups through to established large manufacturers. We are seeking engineers with SaMD (Software as a Medical Device) experience in technical capacity, which can include product design, development, and testing.

Purpose of the position

To build, manage, develop, control, and oversee a portfolio of Medical Device CE marking schemes. To deliver technical documentation assessments in support of these schemes. To provide Medical Device expertise leadership and mentoring to healthcare personnel in areas of competence.

Key Responsibilities & Accountabilities

1. Plan and deliver Technical File Assessments, Design Examinations, and Unannounced Audits to support EC Certification.
2. Manage client projects, acting as the primary contact, and upon satisfactory assessment, make certification recommendations for CE, UKCA, and ISO 13485 certificates to ensure compliance, timely service delivery, and client satisfaction.
3. Provide technical support to the commercial team to support business development and marketing activities as the customer base grows worldwide.
4. Perform unannounced visits to medical device manufacturers globally as a technical expert to verify compliance with certification standards.
5. Collaborate with Line Managers and team leaders to review work within your expertise.

Requirements:

• 4 or more years of Software Medical Device experience in a technical capacity, preferably in product design, development, or testing.
• Understanding of International and National standards for software medical devices design, development, and regulation.
• Knowledge of Risk Management and FMEA for Software Medical Devices.
• Broad technical understanding of medical devices and current industry trends.

Qualifications :

• Bachelor’s degree or equivalent in relevant fields such as biomedical engineering, electronic/electrical engineering, computer science, or medical physics.

What we offer :

BSI offers a competitive salary, ample annual leave/paid time off, and other benefits depending on the country. We invest in our experts' development, including an annual conference for professional growth.

Our Excellence Behaviours :

• Client-centric, Agile, Collaborative

BSI conducts face-to-face interviews where appropriate. If invited for an interview but prefer virtual, please inform our recruitment team.

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