Technical Specialist, Clinical Evaluation Specialist & Scheme Manager - SaMD

BSI; United States; Remote; USD 110,000 - 160,000; Full time

Benefits offered by this job

Medical, dental, vision insurance

401(k) with company contribution

Disability insurance

Job summary

BSI is seeking a Technical Specialist, Scheme Manager, and Clinical Evaluation Specialist - SaMD to join our Software team. This remote, global role focuses on delivering CE marking support for medical device software across the world, including design assessments and audits.

The successful candidate will lead technical evaluations, ensure regulatory compliance, and mentor colleagues. We require 4+ years in software medical devices, strong knowledge of international standards and risk

Qualifications

• 4+ years of Software Medical Device experience in a technical capacity (design, development or testing).
• Understanding of International/National standards for software medical devices design and regulation.
• Knowledge of Risk Management and FMEA for software medical devices.

Responsibilities

• Plan and deliver Technical File Assessments, Design Examinations and Unannounced Audits for EC Certification.
• Manage client projects and provide certification recommendations for CE/UKCA/ISO 13485 to ensure compliance and timely delivery.
• Provide technical support to the commercial team to support business growth and client engagement.

Skills

Software Medical Devices

Regulatory knowledge

Risk Management (FMEA)

International standards

Technical leadership

Education

Bachelor’s degree in engineering or 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, 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

BSI offers a competitive total reward package, an independent and varied job in an international environment, flexible working hours, ongoing training and development. For the US, this role offers 20-days annual leave, bank holidays, medical, dental, vision, and life insurance, 401(K) with company contribution, short-term and long-term disability, maternal leave, paid parental leave, paid bereavement leave, learning and development opportunities, and a wide range of flexible benefits that you can tailor to suit your lifestyle.As the salary differs per country according to various factors, if you reside in another country, you’ll be notified of the salary range by the recruiter.

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.

Through our unique combination of consulting, training, assurance and regulatory services we bring solid and broad knowledge to every company.

_ 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.