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For Companies At a Glance
- Tasks: Manage and assess medical device software projects globally, ensuring compliance and client satisfaction.
- Company: Join BSI, a leader in professional services for medical device manufacturers worldwide.
- Benefits: Enjoy competitive salary, generous leave, and strong professional development opportunities.
- Why this job: Be part of a dynamic team impacting healthcare through innovative software solutions.
- Qualifications: 4+ years in Software Medical Device; degree in relevant engineering or computer science field required.
- Other info: Work remotely with a collaborative culture focused on client-centric excellence.
The predicted salary is between 36000 - 60000 £ per year.
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 a 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.
Our Excellence Behaviours: Client-centric, Agile, Collaborative. These three behaviours represent how we do things at BSI. They help us ensure that BSI is a great place to work and a highly successful business.
BSI is conducting face-to-face interviews where appropriate and possible. If you are invited to a face-to-face interview but feel more comfortable with conducting the interview virtually, please speak to a member of our recruitment team.
Seniority level: Mid-Senior level
Employment type: Full-time
Job function: Health Care Provider
Industries: Professional Services
Technical Specialist, Scheme Manager, Clinical Evaluation Specialist - SaMD employer: BSI
Contact Detail:
BSI Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Technical Specialist, Scheme Manager, Clinical Evaluation Specialist - SaMD
✨Tip Number 1
Familiarise yourself with the latest regulations and standards related to Software as a Medical Device (SaMD). This knowledge will not only help you in interviews but also demonstrate your commitment to staying updated in this rapidly evolving field.
✨Tip Number 2
Network with professionals in the medical device industry, especially those who have experience with CE marking and ISO certifications. Engaging in discussions on platforms like LinkedIn can provide valuable insights and potentially lead to referrals.
✨Tip Number 3
Prepare to discuss specific projects where you've applied risk management and FMEA principles in software development. Real-world examples will showcase your expertise and problem-solving skills, making you a more attractive candidate.
✨Tip Number 4
Research BSI's recent projects and initiatives in the medical device sector. Being knowledgeable about their work will allow you to tailor your conversation during interviews and show that you're genuinely interested in contributing to their mission.
We think you need these skills to ace Technical Specialist, Scheme Manager, Clinical Evaluation Specialist - SaMD
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights your experience in Software as a Medical Device (SaMD). Focus on relevant projects, technical skills, and any certifications that align with the job description.
Craft a Compelling Cover Letter: Write a cover letter that specifically addresses the responsibilities and qualifications mentioned in the job description. Use examples from your past work to demonstrate how you meet their criteria.
Highlight Relevant Experience: In your application, emphasise your 4+ years of experience in medical device software. Discuss your understanding of international standards and risk management practices, as these are crucial for the role.
Showcase Soft Skills: BSI values client-centric, agile, and collaborative behaviours. Make sure to include examples of how you've demonstrated these qualities in your previous roles, as they are essential for success in this position.
How to prepare for a job interview at BSI
✨Showcase Your Technical Expertise
Make sure to highlight your experience with Software as a Medical Device (SaMD) during the interview. Be prepared to discuss specific projects you've worked on, focusing on product design, development, and testing. This will demonstrate your technical capability and understanding of the field.
✨Understand Regulatory Standards
Familiarise yourself with international and national standards relevant to medical devices, such as CE marking and ISO 13485. Being able to articulate how these standards apply to your work will show that you are well-versed in compliance and regulatory requirements.
✨Prepare for Scenario-Based Questions
Expect scenario-based questions that assess your problem-solving skills and ability to manage client projects. Think of examples where you've successfully navigated challenges in technical assessments or audits, and be ready to explain your thought process.
✨Emphasise Collaboration and Client-Centricity
BSI values collaboration and a client-centric approach. Be prepared to discuss how you've worked effectively in teams and how you've prioritised client needs in your previous roles. This will align your values with those of the company.
