Technical Assessor – Sterilization -Non-Active Devices

📝 FULL-TIME

Local Unit & Position Description

DNV Supply Chain and Product Assurance is looking to recruit technical and experienced Active or Non-Active Medical Device Assessor with specific experience in sterilization processes. This position can be remote from anywhere in the Continental U.S.

The successful candidates will be responsible for planning and conducting assessments against the manufacturing of medical devices, in accordance with MDR 745/2017, enabling the delivery of assessment and certification services that meet customer requirements and appropriate accreditation standards.

What You'll Do

Document and report assessment activities and results
Provide timely and accurate reviews of customer corrective action and closure
Conduct assessments (either desk-based or on client’s sites) in accordance with established procedures, maintaining a high standard of service delivery that ensures effective customer relationships.
Conduct Technical File reviews specific for products being authorized.
Complete all chargeable work within the required budget and timeframes to ensure customer satisfaction and efficiency of the business..

Position Qualifications

What is Required

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

Biomedical Engineering
Biology
Medical Technology

In addition to a relevant educational degree, candidates must have a minimum 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 Audit / Assess, and/or experience as an assessor in a notified body (full five technical documentation assessments).

A PhD in a relevant area for medical devices can substitute 3 years of work experience provided it includes 2 years’ experience in design, manufacture or testing.

Non-Active devices

Biomedical Engineering
Biology
Medical Technology

Specific Experience:

You must have experience devices in more than one of the following:

ETO (MDS 1005.1)
Irradiation (MDS 1005.2)
Moist Heat (MDS 1005.3)
Plasma (MDS 1005.4)
Aseptic Processing (MDS 1005.5)
Other (MDS 1005.6)
Reusable surgical instruments (MDS 1006)

Must have experience with Non-Active Devices including:

Non-active polymer implants
Non-active metal implants
Non-active dental

As part of this work experience, risk management experience should be covered:

Practical experience in conducting pre-clinical testing or assessing pre-clinical data with medical devices in one or more of the following areas such as biological safety, physical, chemical and microbiological characterization, stability, shelf life, performance and safety

To be considered for this role, you will have professional experience in a relevant field of healthcare products or related activities, for example:

Work in medical devices industry or closely related industries (e.g. pharmaceutical industry) in a research and development, manufacturing, quality management or regulatory affairs capacity
Work in health services, universities, foundations or other institutions carrying out inspections, audits, clinical evaluations, experimental and/or clinical research, including notified bodies
Work in the application of device technology and its use in health care services and with patients
Testing devices for compliance in accordance to the relevant national or international standards
Conducting performance testing, evaluation studies or clinical trials of devices

In addition to the above the following is advantageous, but can be taught:

An excellent working knowledge of medical device management systems, standards and medical device compliance/auditing techniques
Work experience in positions with significant QA Regulatory or management systems responsibility
Experience with Harmonized medical device standards for active & non active medical devices
Experience with Risk Management EN ISO 14971
Experience with Sterilization techniques (such as ETO, Gamma, Steam, Dry Heat) and formal qualification desirable
Medical device experience from auditing/work
Experience auditing against recognized standards

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

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!