Medical Device Software Specialist

BSI; City Of London; Remote; GBP 80,000 - 100,000; Full time

Job summary

A leading business improvement and standards organization is seeking a Technical Specialist to manage medical device compliance and CE marking schemes. The role involves extensive interaction with global manufacturers, conducting technical assessments, and providing expert guidance within the field of software medical devices. Applicants should have over 4 years of experience and a relevant degree. Competitive salary and robust benefits are offered, along with opportunities for professional development.

Benefits

Competitive salary

Ample annual leave

Professional development opportunities

Qualifications

• 4+ years of experience in a technical capacity related to software medical devices.
• Solid understanding of regulatory standards for medical device design.
• Experience in product design, development, or testing.

Responsibilities

• Plan and deliver Technical File Assessments and Audits.
• Manage client projects and provide certification recommendations.
• Act as technical support for business development.
• Perform compliance checks at medical device manufacturers.

Skills

Software Medical Device experience

Risk Management and FMEA understanding

Interpretation of standards

Broad technical understanding of medical devices

Education

Degree in relevant field

Job description

We exist to create positive change for people and the planet. Join us and make a difference too!

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) in technical capacity which can include product design, development and/or testing.

Purpose of the position

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

Key Responsibilities & Accountabilities

• Plan and deliver Technical File Assessments, Design Examinations and Unannounced Audits to support EC Certification.
• Manage client projects, acting as their primary contact and after satisfactory assessment, to make certification recommendations for CE, UKCA and ISO 13485 certificate issue to ensure compliance with required certification, timely delivery of services and client satisfaction.
• Act as technical support to the commercial team when required to support business development and marketing activities as it grows the customer base worldwide.
• Perform unannounced visits to medical device manufacturers globally as a technical expert to check on compliance with certification.
• Work with Line Manager and other team leaders as required to provide reviews within area of expertise.

Essential Criteria:

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

Qualifications:

• Degree educated (Bachelor’s minimum or equivalent) relevant to medical device design, development, manufacture and use i.e. electro-mechanical, electronic/electrical, biomedical engineering, computer science, medical physics or similar

What we offer:

BSI offers a competitive salary, ample annual leave/paid time off, and other robust benefits depending on country. We invest strongly in the development of our experts, a highlight being an annual conference where our hundreds of experts come together for intensive and exciting continued professional development.

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About Us

BSI is a business improvement and standards company and for over a century BSI has been recognized for having a positive impact on organizations and society, building trust and enhancing lives.

Today BSI partners with more than 77,500 clients in 195 countries and engages with a 15,000 strong global community of experts, industry and consumer groups, organizations and governments.

Utilizing its extensive expertise in key industry sectors - including automotive, aerospace, built environment, food and retail, and healthcare - BSI delivers on its purpose by helping its clients fulfil theirs.

Living by our core values of Client-Centricity, Agility, and Collaboration, BSI provides organizations with the confidence to grow by partnering with them to tackle society’s critical issues – from climate change to building trust in digital transformation and everything in between - to accelerate progress towards a better society and a sustainable world.

BSI is an Equal Opportunity Employer dedicated to fostering a diverse and inclusive workplace.