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Ivd Medical Device Jobs in Indiana (NOW HIRING)

BSI Group

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 ...

BSI Prof Serv EHS West

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 ...

All JobsIvd Medical Device JobsIvd Medical Device Jobs in Indiana

Ivd Medical Device information

What are IVD medical devices?

IVD Medical Devices, or In Vitro Diagnostic Medical Devices, are tools and equipment used to analyze samples such as blood, urine, or tissue taken from the human body. These devices help detect diseases, monitor health conditions, and guide treatment decisions by providing information about a person's health. Common examples include blood glucose meters, pregnancy tests, and laboratory reagents. IVDs play a critical role in disease prevention, diagnosis, and management in both clinical and home settings.

What are some common challenges faced by professionals working in the IVD medical device industry, and how can they be addressed?

Professionals in the IVD Medical Device field often face challenges related to stringent regulatory requirements, rapid technological advancements, and the need for cross-functional collaboration. Navigating evolving regulations can be complex, so staying updated with global standards (such as FDA and EU IVDR) is crucial. Additionally, working closely with R&D, quality assurance, and regulatory teams helps ensure that devices meet both compliance and market needs. Continuous learning and proactive communication are key strategies for overcoming these challenges and driving successful product development.

What are the key skills and qualifications needed to thrive as an IVD medical device specialist, and why are they important?

To thrive as an IVD Medical Device Specialist, you need a strong background in biomedical sciences, regulatory compliance, and quality assurance, often supported by a degree in life sciences or engineering. Familiarity with ISO 13485, FDA regulations, CE marking, and laboratory diagnostic equipment is typically required, along with certifications like RAC or Six Sigma being advantageous. Strong problem-solving skills, attention to detail, and effective communication are essential soft skills for collaborating with cross-functional teams and ensuring product safety. These competencies are crucial for maintaining regulatory standards, ensuring product efficacy, and supporting patient health outcomes.

What is the difference between Ivd Medical Device vs Medical Laboratory Technician?

AspectIvd Medical DeviceMedical Laboratory Technician
CertificationsRegulatory approvals, quality assuranceASCP certification, state licensure
Work EnvironmentManufacturing, quality control, R&DLaboratories, hospitals, clinics
Industry UsageMedical device manufacturing, diagnosticsClinical testing, sample analysis

While both roles are involved in the healthcare industry, Ivd Medical Device professionals focus on the development, regulation, and quality assurance of in vitro diagnostic devices, often working in manufacturing or R&D settings. Medical Laboratory Technicians perform clinical testing and sample analysis in laboratory environments. Understanding these differences helps clarify career paths and industry roles.

What are popular job titles related to Ivd Medical Device jobs in Indiana?

For Ivd Medical Device jobs in Indiana, the most frequently searched job titles are:

What job categories do people searching Ivd Medical Device jobs in Indiana look for?

The top searched job categories for Ivd Medical Device jobs in Indiana are:

What cities in Indiana are hiring for Ivd Medical Device jobs?

Cities in Indiana with the most Ivd Medical Device job openings:

Ivd Medical Device jobs near you

Medical Device Expert- IVD (In Vitro Diagnostic)

BSI Group

Remote

Full-time

Posted 7 days ago

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: EMEA/UK- Homebased

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 cancer and molecular biology.

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. If interested in this position, please submit your CV in English.

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 cancer and molecular biology.
  • Knowledge of medical device regulations.
  • Awareness of certification business processes, the application of quality management standards, and audits

Salary Range: 63,400 - 74,500

This is a remote position that can be based in the UK or within the EMEA region. As compensation varies by country and local market conditions, salary details will be discussed with EMEA candidates prior to the interview stage

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.

If you want to contribute to this inspiring challenge, bring your open and enthusiastic mindset to our dynamic team, apply now and become part of the BSI family!

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.

#LI-REMOTE

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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.

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