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Remote Medical Device Design Jobs in Indiana (NOW HIRING)

BSI Group

Degree educated (Bachelor's minimum or equivalent) relevant to medical device design, development ... LI-REMOTE #LI-SC2 About Us BSI is a business improvement and standards company and for over a ...

BSI Prof Serv EHS West

Degree educated (Bachelor's minimum or equivalent) relevant to medical device design, development ... LI-REMOTE #LI-SC2 About Us BSI is a business improvement and standards company and for over a ...

BSI Group

Japan/South Korea(remote) This role required to work in Japan or South Korea Are you a ... In this role you will have the opportunity to apply your sterile medical device experience to ...

BSI Prof Serv EHS West

Japan/South Korea(remote) This role required to work in Japan or South Korea Are you a ... In this role you will have the opportunity to apply your sterile medical device experience to ...

ProPharma Group

ProPharma helps pharmaceutical, biotech, and medical device companies make sure their products are ... Remote working - with over 85% of our workforce successfully working from home, we can offer a ...

Fortive

Field Service Engineer

Fort Wayne, IN · On-site +1

May advise and assist in affecting design changes to improve equipment efficiency, quality and/or ... Four (4) years work experience in a related field (Medical Device) * Experience working in a field ...

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Remote Medical Device Design information

What is remote medical device design?

Remote medical device design refers to the process of developing and engineering medical devices while working from a location outside of a traditional office or laboratory, often using digital collaboration tools. Professionals in this field may design, prototype, test, and iterate devices such as diagnostic tools, monitoring equipment, or implants, all while collaborating with teams virtually. This approach allows for greater flexibility, access to global talent, and the ability to quickly adapt to changes in project requirements or regulatory standards. Remote medical device designers need strong communication skills, technical expertise, and familiarity with relevant regulations and standards.

What is the difference between Remote Medical Device Design vs Remote Medical Device Manufacturing?

AspectRemote Medical Device DesignRemote Medical Device Manufacturing
Primary FocusConcept development, product design, prototypingProduction, assembly, quality control
Required SkillsCAD, biomedical engineering, regulatory knowledgeManufacturing processes, quality assurance, equipment operation
Work EnvironmentDesign studios, labs, remote collaborationFactories, production lines, remote monitoring
CertificationsBiomedical engineering, FDA regulationsISO standards, manufacturing certifications

Remote Medical Device Design focuses on creating and developing new medical devices, while Remote Medical Device Manufacturing involves producing and assembling these devices. Both roles require specialized knowledge and often collaborate closely, but they differ in their core activities and skill sets.

What are some common challenges encountered when designing medical devices remotely, and how can they be addressed?

One of the main challenges in remote medical device design is effective collaboration, especially when teams are distributed across different time zones and may have limited access to physical prototypes. To address this, teams often rely on advanced digital collaboration tools, virtual whiteboards, and cloud-based CAD platforms to share designs and feedback in real time. Regular virtual meetings and clear documentation protocols are essential for maintaining alignment and ensuring regulatory compliance. Additionally, early and frequent communication with manufacturing and regulatory specialists helps to anticipate and resolve potential issues before they become major obstacles.

What are the key skills and qualifications needed to thrive as a Remote Medical Device Designer, and why are they important?

To thrive as a Remote Medical Device Designer, you need expertise in biomedical engineering, product development, and regulatory standards, often supported by a relevant engineering degree. Familiarity with CAD software, prototyping tools, and knowledge of FDA or ISO regulations is typically required. Excellent problem-solving, communication, and project management skills help in collaborating virtually with cross-functional teams. These skills ensure innovative, compliant device designs that meet clinical needs and succeed in competitive markets.
What are the most commonly searched types of Medical Device Design jobs in Indiana? The most popular types of Medical Device Design jobs in Indiana are:
What are popular job titles related to Remote Medical Device Design jobs in Indiana? For Remote Medical Device Design jobs in Indiana, the most frequently searched job titles are:
What job categories do people searching Remote Medical Device Design jobs in Indiana look for? The top searched job categories for Remote Medical Device Design jobs in Indiana are:
What cities in Indiana are hiring for Remote Medical Device Design jobs? Cities in Indiana with the most Remote Medical Device Design job openings:
Remote Medical Device Design jobs near you

Technical Specialist, Clinical Evaluation Specialist & Scheme Manager - SaMD

BSI Group

Remote

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Posted 9 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, 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.

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

#LI-SC2

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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