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Medical Devices Risk Assessment Jobs (NOW HIRING)

BSI Group

You will assess cutting edge technology that will make a difference in patient health and safety ... Understanding of the principles of design control and risk management. * Strong interpersonal ...

BSI Prof Serv EHS West

You will assess cutting edge technology that will make a difference in patient health and safety ... Understanding of the principles of design control and risk management. * Strong interpersonal ...

Tunnell Government Services

Toxicologist

Bethesda, MD · On-site

Information Needed for Assessment by the FDA (website) * Standards: * ISO 10993-1:2018, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process

LanceSoft Inc

Medical Writer I

Raritan, NJ · On-site

The applicant will write Product Risk Assessment documents for Pharmaceutical Products and require specific experience in Risk assessments of combination products and/or medical devices. The ...

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Medical Devices Risk Assessment information

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$51.5K

$111.6K

$170K

How much do medical devices risk assessment jobs pay per year?

As of May 30, 2026, the average yearly pay for medical devices risk assessment in the United States is $111,556.00, according to ZipRecruiter salary data. Most workers in this role earn between $90,000.00 and $129,000.00 per year, depending on experience, location, and employer.

What are the key skills and qualifications needed to thrive in Medical Devices Risk Assessment, and why are they important?

To thrive in Medical Devices Risk Assessment, you need a solid background in biomedical engineering or a related scientific field, combined with knowledge of regulatory requirements such as ISO 14971. Familiarity with risk management tools, failure mode and effects analysis (FMEA), and regulatory submission systems is typically required. Attention to detail, analytical thinking, and effective communication are vital soft skills for clearly documenting and presenting risk findings. These competencies ensure that medical devices meet safety standards, minimize patient risk, and achieve regulatory approval.

What are some common challenges faced by professionals in Medical Devices Risk Assessment, and how can they be overcome?

Professionals in Medical Devices Risk Assessment often encounter challenges such as keeping up with rapidly changing regulatory requirements, effectively communicating risk findings to cross-functional teams, and managing complex technical documentation. Staying up-to-date with global standards (like ISO 14971) and participating in regular training can help address regulatory shifts. Developing strong communication skills is essential for ensuring that risk mitigation strategies are understood and implemented by engineering, quality, and clinical teams. Additionally, utilizing robust documentation tools and processes streamlines the risk management workflow and ensures compliance during audits.

What is medical devices risk assessment?

Medical devices risk assessment is the process of identifying, evaluating, and mitigating potential risks associated with the use of medical devices. It involves analyzing how a device might fail, the likelihood and severity of harm, and implementing controls to minimize patient and user risks. This process is essential for regulatory compliance and ensures the safety and effectiveness of medical devices throughout their lifecycle.

What is the difference between Medical Devices Risk Assessment vs Medical Devices Quality Assurance?

AspectMedical Devices Risk AssessmentMedical Devices Quality Assurance
Primary FocusIdentifying and evaluating potential risks associated with medical devicesEnsuring products meet quality standards and regulatory requirements
CertificationsISO 14971, regulatory compliance knowledgeISO 13485, quality management system expertise
Work EnvironmentRisk analysis, safety evaluations, documentationQuality audits, process validation, documentation
Industry UsageRisk management during device development and post-marketQuality control during manufacturing and post-market

While both roles are essential in the medical device industry, Medical Devices Risk Assessment focuses on identifying and mitigating potential safety risks, whereas Medical Devices Quality Assurance emphasizes maintaining product quality and compliance throughout the manufacturing process.

Infographic showing various Medical Devices Risk Assessment job openings in the United States as of May 2026, with employment types broken down into 40% Full Time, and 60% Contract. Highlights an 80% In-person, and 20% Remote job distribution, with an average salary of $111,556 per year, or $53.6 per hour.

Design Transfer Engineer - Medical Devices

Gilero, A Sanner Group Company

Pittsboro, NC

Other

Medical, Dental, Vision, Life, Retirement

Posted 25 days ago

Job description

Do you have a passion for helping design and manufacture innovative medical and drug delivery devices that can improve lives? At Gilero’s Pittsboro, NC location, we are looking for a Design Transfer Engineer to help lead our mission-driven team with purpose and dedication, fostering inclusivity and teamwork to create innovative solutions for patients and customers.

Design Transfer Engineers draw on experience to oversee and champion the development and production of medical devices and combination devices, focusing on idea generation, verification, validation, and DHF development to state-of-the-art requirements.


In this role, you would manage technical risks and ensure high-quality outcomes, ensuring seamless collaboration with customers, vendors, and internal teams. You would also mentor junior engineers, promoting excellence and future success. The work of a Senior Design Transfer Engineer should have a sense of pride, characterized by curiosity, attention to detail, and organizational excellence.


Responsibilities

  • Act as a technical support, increasing the rigor of technical product development, with project support of products, accessories, and cross-functional initiatives
  • Manage product development deliverables through the entire development lifecycle, with a focus on manufacturing transfer
  • Support sustaining engineering activities for products in commercial manufacturing
  • Write and execute protocols to assess manufacturing process capability (IQ/OQ/PQ)
  • Maintain Device Master Record (DMR) and ensure documents are complete, accurate, and current including process routers, inspection plans, temporary deviations, and nonconformances
  • Participate in manufacturing investigations/CAPA resolutions to identify improvements to the manufacturing processes
  • Support the quotation process for engineering projects and commercial manufacturing
  • Facilitate design transfer of existing products to and from other manufacturing sites
  • Track technical risk and provide engineering guidance
  • Seek feedback and mentorship from senior engineers
  • Help lead the development team through technical risk retirement. Support the team on technical risks through step-by-step simplification to discover root cause
  • Create, review, and release documents according to Gilero’s QMS and the lifecycle of the project and develop test methods and protocols to fulfill state of the art requirements
  • Keep project managers informed on technical projects variables and status
  • Prepare documentation to support design history files and regulatory submissions
  • Analyze test data, interpret results, formulate conclusions, and apply statistical techniques (t-test, ANOVA, UCL/LCL, Tolerance Intervals)
  • Draft Risk documentation through understanding of Risk, Risk analysis, & Risk Burn Down
  • Support delivery of project objectives and milestones
  • Participate in testing campaigns, test flows, sample size analysis, and justification, based on sound judgment, Risk analysis, and QMS requirements
  • Support product and process risk assessments, including hazard analysis, FMEAs and residual risk analysis in conjunction with Quality Engineering
  • Write and execute protocols for design verification and validation
  • Support test method development and validation
  • Oversee and perform testing and inspection of prototypes and pre-production products including assisting assembly for DV&V builds and clinical builds
  • Support investigation of device failures, coordinate resources, determine root cause, identify corrective actions, and document in conjunction with Quality Engineering
  • Investigate, evaluate, and research competitive devices and product materials/designs


Skills/Qualifications:

  • BS in Engineering or equivalent technical degree
  • 1+ years relevant working experience in product development, 2+ preferred. Medical device or combination product experience preferred
  • Skilled at transforming technical situations into well-defined project deliverables
  • Understanding of good GDP
  • Understanding of the Phase Gate System
  • Exposure and understanding of ISO 14971, 13485 and CFR 21 Knowledge base
  • Ability to translate User Needs/Requirements into measurable technical/product requirements and set appropriate specification though thought experiments and empirical testing
  • Ability to support and document appropriate scenarios for rationale-based decisions versus testing-based approaches
  • Ability to author scientific/logic-based rationale
  • Awareness of pre-clinical validation and GLP
  • Ability to review and understand technical drawings and GD&T to support development lifecycle
  • Ability to review, understand, and distill technical standards (ISO, ASTM, IEC, etc)
  • Excellent communication skills (oral and written)


Personal Attributes:

  • Meets Gilero Core Values:
  • Collaboration - embracing teamwork and transparency in our organization, partnering with our customers and vendors
  • Integrity - doing the right thing at all times; fair and trustworthy; always keeping the patient in mind
  • Innovation - open to new ideas, processes, and solutions; leveraging technology to creatively solve problems
  • Excellence - delivering exceptional products and services with passion and pride
  • Comfortable and productive in a fast-paced, entrepreneurial environment
  • A self-starter seeking a career opportunity with potential for internal advancement, seeking
  • responsibility for core activities and providing high-quality service to internal and to external clients
  • Commitment to excellence and quality service to external and internal customers
  • Follow established policies and procedures, while contributing to continuous improvements


Eligibility To Work:

  • Applicants must be permanently authorized to work in the United States without the need for employer sponsorship now or in the future.
  • Gilero does not offer sponsorship for employment authorizations (work visas).
  • We are an E-Verify employer and confirm work authorization for all new hires.


Why work at Gilero?

Founded in 2002, Gilero, a Sanner Group company, is an international contract engineering firm that specializes in the design, development, and manufacturing of novel medical devices and drug delivery products. At Gilero, we are proud of the culture we have built that directly reflects our values of excellence, integrity, innovation, and collaboration. Motivated by our purpose to benefit people and improve patient outcomes, our team continues to grow at a rapid pace. US locations include Carlsbad, CA; Chicago, IL; as well as NC locations in Raleigh, Durham, Greensboro, and Pittsboro.


You will enjoy an annual bonus plan, Medical (3 BCBS plans to choose from), dental and vision, company-provided life insurance, short-term and long-term disability, 401(k) with a match the first month you start with a zero-vesting period, and access to LinkedIn learning for personal and professional development.


Featured benefits

  • Medical insurance
  • Vision insurance
  • Dental insurance
  • 401(k)
  • Paid maternity leave
  • Paid paternity leave
  • Disability insurance

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