IVD (In Vitro Diagnostic) Medical Device Technical Expert

BSI; United States; Remote; USD 90,000 - 134,000; Full time

Job summary

BSI is seeking a Technical Specialist for IVD devices to lead CE marking schemes and provide technical reviews and QMS guidance from a home-based position with travel. The role emphasizes design control, risk management, and regulatory knowledge for infectious disease devices.

The ideal candidate holds a degree in an IVD-related field and has 4+ years of post-graduate experience in design and development of IVD medical devices, including clinical evaluation activities and awareness of regulatory

Qualifications

• Bachelor’s degree or higher in a discipline relevant to IVD medical device design, manufacture and use, or equivalent qualification.
• At least 4 years’ post-graduate experience in the design and development of IVD medical devices, including the principles of design control, risk management and performance and/or clinical evaluation primarily focusing on IVD infectious diseases.
• Knowledge of medical device regulations and awareness of certification business processes, quality management standards, and audits.

Responsibilities

• Build, control and manage a portfolio of Medical Device CE marking schemes focused around your area of expertise
• Deliver technical reviews, scheme management in support of the CE marking schemes
• Provide Medical Device QMS assessment and device expertise leadership and mentoring in areas of competence to Healthcare personnel
• Provide “Technical Sales/Networking” support to the commercial team

Skills

Analytical thinking

Strong communication

Detail oriented

Education

Bachelor’s degree in IVD-related 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- IVD (In Vitro Diagnostic)**

Location: China

BSI is seeking R&D Scientists and Production Scientists to join our IVD Devices Team as a Technical Specialist and Scheme Manager for CE Marking clients. Specifically we are seeking people with knowledge of the design and manufacture of IVD infectious diseases

Our Technical Specialists are industry experts that are analytical, communicative, diligent, and always curious. If you are looking for a career change and want to make an impact on patient safety – this may be a great fit for you! This is a home-based position with some travel.

Essential Responsibilities:

• Build, control and manage a portfolio of Medical Device CE marking schemes focused around your area of expertise
• Deliver technical reviews, scheme management in support of the CE marking schemes
• Provide Medical Device QMS assessment and device expertise leadership and mentoring in areas of competence to Healthcare personnel
• Provide “Technical Sales/Networking” support to the commercial team

The ideal candidate will possess the following characteristics:

• Bachelor’s degree or higher in a discipline relevant to IVD medical device design, manufacture and use, or equivalent qualification.
• At least (4) years’ post-graduate experience in the design and development of IVD medical devices, including the principles of design control, risk management and performance and/or clinical evaluation primarily focusing on IVD infectious diseases
• Knowledge of medical device regulations.
• Awareness of certification business processes, the application of quality management standards, and audits

BSI offers a competitive total reward package, an independent and varied job in an international environment, flexible working hours, ongoing training and development.

Do you believe the world deservesexcellence?

We are proud to be the business improvement company for other organisations to become more sustainable and resilient and finally to inspire trust in their products, systems, services, and the world we live in.

Headquartered in London, BSI is the world’s first national standards organization with more than 100 years of experience. We are a global partner for 86,000 companies and organizations in over 193 countries, offering development, auditing, certification, and training services, including innovative software solutions and cyber security expertise for all industries: from aerospace and automotive to food, construction, energy, healthcare, IT and trade sectors. Incorporated by Royal Charter, we’re truly impartial, and home to the ultimate mark of trust, the Kitemark.

D&I Policy

BSI is committed to ensuring the diversity of our workforce reflects that of our clients and the communities in which we operate.__Our goal is to create a sense of belonging for all employees by providing opportunities to develop, grow, andengage with our global organization all while having fun doing great work.BSI is a community where everyone can thrive.

If you require any reasonable accommodations to be made on account of a disability orimpairment throughout out our recruiting process,please inform your Talent Acquisition Partner.

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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.