Technical Assessor - Active Medical Devices - Software and Devices controlled by Software

Local Unit & Position Description

DNV Supply Chain and Product Assurance has immediate openings on our growing Medical Device Team!

DNV Supply Chain and Product Assurance is looking to recruit technical and experienced personnel to be Active Medical Device Assessors throughout North America with expertise specific to stand-alone software and/or medical devices controlled by software. This position can be remote from anywhere in the Continental U.S.A.

The successful candidate(s) will be responsible for conducting product reviews of client technical documentation, in accordance with the Medical Device Regulation (EU 2017/745), enabling the delivery of certification services that meet customer requirements and appropriate accreditation standards.

Job Summary:

Individuals in this role must have successfully completed a university or technical college degree in the following or similar degree fields: Biomedical Engineering, Mechanical Engineering, Electrical / Electronics Engineering, Computer / Software Engineering or Medical Technology.

This role requires 4-years of professional experience working in the medical device industry, in the field of healthcare products or related activities. Professional experience must include at least 2-years in the design, manufacture, testing or use of the medical device or technology to be assessed or related to the scientific aspects to be assessed.

The successful candidate possesses knowledge and understanding covering a wide range of medical device technologies and hands-on experience in the development, manufacturing / programming, testing and validation of medical device software and / or medical devices controlled by software.

What You'll Do:

• Assess / review client s technical documentation / medical device files against the Medical Device Regulation [EU 2017/745].
• Interact directly with customers at all levels of management in developing timely, complete, and accurate reports of their current level of compliance and implementation of their technical documentation.
• Document and report assessment activities and results utilizing analytical skills, technical knowledge, and excellent written communication skills.
• Provide timely and accurate reviews of customer corrective actions.
• Conduct assessments in accordance with established procedures, maintaining a high standard of service delivery that ensures effective customer relationships.
• Conduct Technical Documentation reviews specific to products being authorized.
• Analyze complex regulatory requirements and make sound determinations of the proper course of action.
• Work with minimal supervision with the ability to assess compliance to regulatory requirements.
• Work independently or within a team environment utilizing positive interactive skills.
• Maintain appropriate assessor credentials and pursue advancement of those credentials and other related credentials as needed.
• Complete all chargeable work within the required budget and timeframes to ensure customer satisfaction and efficiency of the business.

Position Qualifications

What Is Required What Makes a Successful Candidate:

Education:

Assessors shall have a university or technical college degree in a relevant product or medical area, as described below:

• Biomedical Engineering or Bioengineering
• Mechanical Engineering
• Electrical or Electronics Engineering
• Computer or Software Engineering
• Medical Technology

Experience:

In addition to a relevant educational degree, candidates must have a minimum of 4-years work experience (full time) in a medical device related industry, with at least 2 of these years in the design, manufacturing, testing or use of the device in which they are qualified to assess, and/or experience as an assessor at a notified body [five full technical documentation assessments completed].

A Ph.D. in a relevant area for medical devices can substitute 3-years of work experience if it includes at least 2-years of experience in the design, manufacture and/or testing of medical devices.

Experience with Active Medical Devices may include design, manufacturing, programming, testing, validation, or use of the following devices:

• Standalone software
• Medical Devices incorporating software, utilizing software, controlled by software, including devices intended for controlling, monitoring, or directly influencing the performance of active or active implantable medical devices.
• Active (non-implantable) medical devices

To be considered for this role, you will have professional experience in the medical device industry, in the field of healthcare products or related activities, including but not limited to the following:

• Experience with software including direct, hands-on experience with the development, programming, testing and verification and validation of medical device software and / or medical devices controlled by software.
• Direct, hands-on experience with design, development, manufacture, testing and verification and validation of active (non-implantable) medical devices.
• Work experience in medical devices industry or closely related industries (e.g., pharmaceutical industry) in a research and development, manufacturing, or quality engineering.
• Work experience in health services, universities, foundations, or other institutions carrying out inspections, audits, clinical evaluations, experimental and/or clinical research, including notified bodies.
• Work experience in the application of device technology and its use in health care services and with patients.
• Testing devices for compliance in accordance with the relevant harmonized, national or international standards.
• Experience in conducting pre-clinical testing or assessing pre-clinical data with medical devices in one or more of the following areas: (a) biological safety, physical, chemical, and microbiological characterization, (b) Electrical safety and Electromagnetic compatibility, (c) Software verification and validation, (d) Stability and shelf-life, and (e) performance and safety testing.

General Expectations:

• Broad knowledge of engineering and technical applications used in the development of medical devices.
• In depth knowledge of the Software life cycle processes for medical device software (EN 62304).
• Excellent interpersonal, verbal, written and presentation skills.
• Strong analytical skills while handling multiple projects, delivering results on time using well developed problem-solving skills.
• Pro-active attitude and excellent organizational skills and the ability to work independently as well as within project teams.
• Strong background in either design engineering or R & D.
• Excellent working knowledge of medical device management systems and medical device standards (harmonized, national and international) for active medical devices and software.
• Experience with Risk Management (EN ISO 14971).

Previous experience as an Assessor with a Notified Body is not required.

We conduct a pre-employment background check and drug screen.

What We Offer:

• Generous Paid Time Off (Vacation, Company Holidays, Parental Leave, Sick, and Disability).
• Multiple Medical, Dental, and Vision Benefit Plans to choose from.
• Spending Accounts - FSA, Dependent Care, Commuter Benefits, Company-Seeded HSA.
• 401(K) with company match.
• Company provided life insurance, short-term, and long-term disability benefits.
• Education reimbursement program.
• Employer-Paid, therapist-led, virtual care services through Talkspace.
• Flexible work schedule with hybrid/remote opportunities.

**Benefits may vary based on position, tenure, location, and employee election

How We Do It:

We Care, We Dare, We Share

DNV is a proud equal opportunity employer committed to building an inclusive and diverse workforce. All employment is decided on the basis of qualifications, merit or business need, without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

DNV is committed to ensuring equal employment opportunity, including providing reasonable accommodations to individuals with a disability. US applicants with a physical or mental disability who require a reasonable accommodation for any part of the application or hiring process may contact the North America Recruitment department (hrrecruitment.northamerica@dnv.com). Information received relating to accommodations will be addressed confidentially.

DNV is proud to announce being named one of Houston's best places to work in the 2022 Houston Business Journal - Best Places to Work competition.

For more information about your rights under the law, see:

https://www.eeoc.gov/know-your-rights-workplace-discrimination-illegal-poster

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Diversity at DNV

Meet our Employees

About DNV

Careers in DNV

As required by the Pay Transparency laws in Colorado, New York City, California, and Washington, DNV provides a reasonable range of compensation for roles that may be hired in those locations. Actual compensation is influenced by a wide array of factors including but not limited to skill set, level of experience, and specific office location. For the state of Colorado, New York City, NY, California, and Washington only, the range of starting pay for this role is $90000 - $150000.

Company & Business Area Description

DNV Supply Chain & Product Assurance

DNV is an independent assurance and risk management provider, operating in more than 100 countries. Through assessment and digital assurance solutions, DNV helps companies build trust and transparency around products, assets, supply chains and ecosystems.

Whether certifying products, verifying claims or optimizing and decarbonizing supply chains, DNV helps companies manage risks and realize their long-term strategic goals, improving ESG performance and generating lasting, sustainable results.

Combining sustainability, supply chain and digital expertise, DNV works to create new assurance models enabling interaction and transaction transparency across value chains. Drawing on our wide technical and industry expertise, we work with companies worldwide to bridge trust gaps among consumers, producers and suppliers.

Driven by its purpose, to safeguard life, property, and the environment, DNV helps tackle the challenges and global transformations facing its customers and the world today and is a trusted voice for many of the world s most successful and forward-thinking companies.

Equal Opportunity Statement

DNV is an Equal Opportunity Employer and gives consideration for employment to qualified applicants without regard to gender, religion, race, national or ethnic origin, cultural background, social group, disability, sexual orientation, gender identity, marital status, age or political opinion. Diversity is fundamental to our culture and we invite you to be part of this diversity!