Technical Assessor - Austin, United States - DNV

DNV

Verified Company

Austin, United States

3 weeks ago

Posted by:

Mark Lane

beBee recruiter

Description

About us:

We are the independent expert in assurance and risk management.

Driven by our purpose, to safeguard life, property, and the environment, we empower our customers and their stakeholders with facts and reliable insights so that critical decisions can be made with confidence.

As a trusted voice for many of the world s most successful organizations, we use our knowledge to advance safety and performance, set industry benchmarks, and inspire and invent solutions to tackle global transformations.

About the role:

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.

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.

What You'll Do:

Assess / review clients 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 mínimal 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.

What we offer:

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, shortterm, and longterm disability benefits.
Education reimbursement program.
Employer-Paid, therapistled, 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 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:

Read more here:
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 $ $150000.

About you:

Education:

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