Design Assurance Engineer Job Description (2022)

Job Descriptions

Design Assurance EngineerJob Description

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152votesfor Design Assurance Engineer

Design assurance engineerprovides technical expertise to the manufacturing floor in the areas of root cause analysis, troubleshooting, process problem solving, risk analysis, statistical analysis, and process improvements.

Design Assurance EngineerDuties & Responsibilities

To write an effective design assurance engineer job description, begin by listing detailed duties, responsibilities and expectations. We have included design assurance engineer job description templates that you can modify and use.

Sample responsibilities for this position include:

Support reprocessing studies in areas of but not limited to cleaning, disinfection and sterilization in achieving a safe and effective resuable device that conforms to FDA reprocessing guidance, TIR12, TIR30, ST79 and any other relevant standards or regulations

Review and support terminal sterilization studies in areas of but ethylene oxide sterilization in achieving a safe and effective resuable device that conforms relevant standards (ISO 11135 series, ISO10993-7, ) or regulations

Review and support aging studies for sterilie packaging or device degradation that conforms relevant standards (ASTM F-1980, ISO 11607-1, relevant 10993 series for degradation or materical characterization ) or regulations

Review and support biocompatibility to ensure device is correctly classifieced and conforms relevant standards and guidances (FDA guidance and relevant 10993 series for degradation or materical characterization ) or regulations

Support reprocessing studies in areas of but not limited to cleaning, disinfection and sterilization in achieving a safe and effective reusable device that conforms to FDA reprocessing guidance, TIR12, TIR30, ST79 and any other relevant standards or regulations

Support terminal sterilization studies in areas of but ethylene oxide sterilization in achieving a safe and effective reusable device that conforms relevant standards (ISO 11135 series, ISO10993 series, ) or regulations

Lead/Support aging studies in both accelerated and real time for sterile packaging or device degradation that conforms to relevant standards (ASTM F-1980, ISO 11607-1, ) or regulations

Support biocompatibility to ensure device conforms to relevant standards and guidance’s (FDA guidance and relevant 10993 series for degradation or material characterization) or regulations

Demonstrate good working knowledge and application of validation and statistical techniques in order to comply with associated regulatory requirements and internal standards

Serve as Core team member on New Product Development projects to ensure compliance with design controls per ISO 13485 and FDA QSR

Design Assurance EngineerQualifications

Qualifications for a job description may include education, certification, and experience.

Licensing or Certifications forDesign Assurance Engineer

List any licenses or certifications required by the position:ASQ, CQE, ISO, ISO13485, FDA, 9001, QMS, AS9100D, CMMI, CRE

Education forDesign Assurance Engineer

Typically a job would require a certain level of education.

(Video) What Is a Quality Assurance Engineer? | Should You Become One? | Ask a Dev

Employers hiring for the design assurance engineer job most commonly would prefer for their future employee to have a relevant degree such asBachelor's and Master's DegreeinEngineering, Technical, Science, Life Sciences, Medical, Electrical Engineering, Mechanical Engineering, Education, Computer Science, Design

Skills forDesign Assurance Engineer

Desired skills fordesign assurance engineerinclude:

ISO 13485

Failure Mode and Effects Analysis

Industrial Statistical Methods and Lean Manufacturing

Process Capability Studies

Related engineering areas to own areas of expertise

Statistical Process Control

Problem solving tools

Capable of facilitating problem solving process

Standards

Desired experience fordesign assurance engineerincludes:

Support various QA/RA activities including quality management, system reviews, audits

Root cause investigations

Own, draft and facilitate DCAF (design change analysis) for all post commercialization design related changes with cross functional teams

Able to lead and drive updates of Design FMEA or related Risk Management activities with relevant cross functional teams in mimizing redundant efforts

Participates in project teams to review and update clear and concise user requirements, product specifications, plans, verification and validation studies, risk management file and other relevant design control deliverables

Have biomedical exposure and knowledge in performing representative risk analysis and hazard identification

Design Assurance EngineerExamples

1

(Video) Certification and Design Assurance Engineering

Design Assurance Engineer Job Description

Job Description Example

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  • Microsoft Word (.docx).DOCX
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Our company is growing rapidly and is looking to fill the role of design assurance engineer. To join our growing team, please review the list of responsibilities and qualifications.

Responsibilities for design assurance engineer

  • Perform analysis of reports and production data to identify trends and recommend updates or changes to quality standards and procedures when necessary
  • Demonstrate mastery and application statistical techniques in order to comply with associated regulatory requirements and internal standards
  • Supports FDA 21CFR820.30 and ISO 13485 requirements by creating and reviewing design control deliverables and requirements
  • Provide Regulatory guidance to ensure device is correctly classified and conforms to relevant standards and guidelines
  • Lead or support non-conformance or CAPA related initiatives with NCEP and eCAPA process
  • Review and support Electrical and Laser compliance studies to ensure device electrical safety is maximized mitigated through standardized approach in conforming to IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22 and IEC- 60825
  • Utilize statistical methods ranging from distribution fitting, establising reliability and confidence levels to facilitate predictability, process capability evaluation for Gaussian distributions, application and limitations of six σ techniques, and correlating n to confidence and reliability levels to promote and made aware of statistical significance
  • Articulate quality initiatives and considerations with internal and external customers
  • Able to lead and drive creation Risk Management Files including Design/Use FMEA with relevant cross functional teams in minimizing redundant efforts
  • Lead/Support Human Factor studies to ensure device's use errors are minimized or mitigated through standardized approach in conforming to IEC 62366, or AAMI HE75

Qualifications for design assurance engineer

  • Two to three years of experience working in a Quality function in the medical device industry
  • Assures Quality System compliance and adherence to the BSC Quality Policy
  • Providing quality and compliance input to the project team for project decisions and deliverables
  • Generation of Quality deliverables such as Design and Development Plans and Field Assessment Plans
  • Providing quality and compliance input for post market product sustaining activities, such as design changes, supplier auditing and surveillance, product marking and safety certification, customer complaints, PIR’s and CAPA’s
  • Reviewing and providing feedback to R&D and test team on their deliverables including Development Plan, Risk Management, V&V Plan, test cases, trace matrix, Work closely with R&D and test teams

2

Design Assurance Engineer Job Description

Job Description Example

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  • Microsoft Word (.docx).DOCX
  • PDF Document (.pdf).PDF
  • Image File (.png).PNG

Our company is growing rapidly and is looking to fill the role of design assurance engineer. We appreciate you taking the time to review the list of qualifications and to apply for the position. If you don’t fill all of the qualifications, you may still be considered depending on your level of experience.

Responsibilities for design assurance engineer

  • Ensuring development is compliant with internal and external standards
  • Current in knowledge of applicable federal and state healthcare regulations, laws and accreditation standards
  • Experienced in compliance laws and regulations, access, release of information, and release control technologies including 21 CFR 820, 21 CFR 803, 21 CFR 806, ISO 13485, ISO 14971, IEC 62304 and the Medical Device Directive
  • Experienced with standards for the design, verification, and validation of medical device products
  • Support test method validation studies of design verification or validation test methods utilizing tools such as Gage R&R, error analysis, and Regression models to identify transfer functions
  • Utilize statistical methods ranging from distribution fitting, establishing reliability and confidence levels to facilitate statistical analysis
  • Actively promote and participate in a cross-functional teamwork environment
  • Provide Quality Engineering support to cross-functional development team for machined components and subassemblies
  • Lead the development of and coordinate the execution and documentation of Design Validation and Verification activities
  • Implement and support reliability program for device implant and materials

Qualifications for design assurance engineer

  • Medical Device or regulated environment experience preferred
  • Demonstrable ability to solve complex problems
  • Working experience in a global environment spanning multiple sites and systems
  • BS in Electrical, Computer/Software, or Biomedical Engineering
  • Able to lead and drive creation of Design or Process FMEA with relevant cross functional teams in mimizing redundant efforts
  • Ensure environmental compliance of products

3

Design Assurance Engineer Job Description

Job Description Example

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  • Microsoft Word (.docx).DOCX
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(Video) Information Assurance Engineer job description #informationassuranceengineer

Our growing company is looking to fill the role of design assurance engineer. Thank you in advance for taking a look at the list of responsibilities and qualifications. We look forward to reviewing your resume.

Responsibilities for design assurance engineer

  • Lead the determination and implementation of Design controls based on Risk Management, Customer Needs, and Manufacturing Input
  • Coordinate and Lead Root Cause investigations, corrective action determinations, and verification of effectiveness
  • Identify, coordinate, and monitor internal and external resources to complete assigned tasks within a predetermined timeline
  • Perform regulatory standard assessments and support regulatory submissions to notified bodies
  • Support the Design Control System during audit activities
  • Establish and maintain Design History File and Design Input / Output documentation (Product Specification, Component Specifications, and Prints)
  • Develop and/or implement quality planning techniques in a medical design/manufacturing environment for new product introductions
  • Participate in Design Reviews and identify improvements based on relevant risk analysis, past manufacturing experience, and Marketing/Customers’ specifications/requirements for products
  • Establish and participate in supplier qualification/development activities to ensure that products meet design and manufacturing requirements as part of Design Transfer
  • Advise and evaluate product verification/validation activities

Qualifications for design assurance engineer

  • Experience with TAVI or Mitral Valve replacement technologies an advantage
  • 5 - 8 Years experience with BS in Mechanical / Biomedical Engineering or related discipline or equivalent combination of education and experience to perform at this level
  • 1-3 years medical device experience required with implantable device experience preferred
  • Previous surgical or transcatheter valve experience preferred
  • Develop/Use Key Process Indicators to determine process effectiveness, identify areas for improvement, best practices, and drive continuous quality improvement
  • Lead cross-functional teams in the execution and reporting of quality improvement projects with a focus on overall process improvements, scrap reduction and supplier quality improvement

4

Design Assurance Engineer Job Description

Job Description Example

Download

  • Microsoft Word (.docx).DOCX
  • PDF Document (.pdf).PDF
  • Image File (.png).PNG

Our company is looking for a design assurance engineer. If you are looking for an exciting place to work, please take a look at the list of qualifications below.

Responsibilities for design assurance engineer

  • Lead test method validation for engineering and design verification testing
  • Summarizes results of experiments by creating tables, charts and reports
  • Must be able to interpret data and convey results
  • Articulate quality initiatives and considerations with internal and external customers and championing quality initiatives within project teams
  • Leads the design and analysis of inspection and testing methods
  • Assists with managing Part Files that define statistical analysis requirements and any associated control limits
  • May provide direction and mentoring to junior QA Engineers
  • Demonstrated competence in Quality Engineering body of knowledge
  • Assist in the selection of appropriate analytical procedures
  • Writes, reviews, approves design verification reports in accordance with industry expectations

Qualifications for design assurance engineer

  • A Bachelor's degree in Engineering (Chemical Engineering, Chemistry, Bio-Chemistry, or related discipline)
  • Minimum 5 to 8 years of related experience in Medical Device / Biologics/ IVD manufacturing environment
  • May perform other Quality related duties and responsibilities as assigned
  • BS degree or equivalent, Masters preferred
  • 5+ years of related experience within the Medical Device Industry
  • Statistics / Analytics expertise a must

5

Design Assurance Engineer Job Description

Job Description Example

Download

  • Microsoft Word (.docx).DOCX
  • PDF Document (.pdf).PDF
  • Image File (.png).PNG

Our company is growing rapidly and is hiring for a design assurance engineer. Please review the list of responsibilities and qualifications. While this is our ideal list, we will consider candidates that do not necessarily have all of the qualifications, but have sufficient experience and talent.

Responsibilities for design assurance engineer

(Video) Role of a QA engineer | QA engineer job description | By Elizabeth Turner

  • Provides supervision and project direction for a small team of engineers and technical personnel
  • Execute the investigation, risk assessment, disposition of non-conforming events and Corrective/Preventative Action
  • Support Software Risk Management per ISO14971 and ISO 62304
  • Support Human Factor studies to ensure device's use errors are minimized or mitigated through standardized approach in conforming to EN 62366, and AAMI HE75
  • Providing design quality assurance support in the development of medical device products, and facilitating the application of design controls and V&V system/software validation
  • Providing design assurance support for post market surveillance processes when design changes are required
  • Ensuring development activities are planned, documented, and executed to satisfy regulatory, customer and designated internal requirements
  • Actively supporting product development projects by coaching teams to create Project Development Plans, Design Inputs and Outputs, Design History Files, Risk Management, Test strategy, Verification and Validation plans, Test Traceability
  • Participating in product risk assessment efforts, including hazard analysis and design failure mode effect analysis
  • Reviewing and approving design verification and validation test plans, protocols and reports

Qualifications for design assurance engineer

  • 2+ years of work experience with BS in Quality Engineering or related discipline or 0-2 years of work experience with MS in Quality Engineering or related discipline
  • ASQ / Six Sigma Certification preferred
  • Microsoft Office products (Excel, Word and PowerPoint)
  • 5 - 8 years experience with BS in Engineering, Quality or related degree
  • Previous experience with basic project management and problem solving
  • Medical device or other highly regulated industry experience

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FAQs

What is design Assurance Engineer? ›

They ensure that compliance to customer, risk management, quality, and Design Control requirements is demonstrated and help to ensure successful transfer of the design to manufacturing.

What does design assurance do? ›

Design assurance is the process of discovering, preventing, and correcting errors earlier in the design engineering life cycle when these problems are less expensive and possible to correct.

What are the responsibilities of a design engineer? ›

Responsibilities
  • Design new engineering products and processes.
  • Craft models and drawings of products using CAD.
  • Analyze prototype data and retest if needed.
  • Research new product ideas and methods.
  • Improve existing products and processes.
  • Ensure compliance with the industry's safety standards.
  • Maintain accurate records.

What is design assurance level? ›

DALs, Design Assurance Levels, are the key measures assigned to software and hardware functions used to determine the level of stringency applied to different components of an avionics system.

What is Assurance in engineering? ›

Effective assurance represents a planned set of system-level and service level criteria that converges to ultimately demonstrate that applied engineering procedures, methods, processes, and disciplines can be substantiated by a suitable level of evidence that confirms that the system and delivered services conform to ...

What is design quality assurance in medical devices? ›

Quality Assurance (QA)

It's the job of a QA expert team to maintain these processes to ensure high-quality products are delivered. Talking about medical devices, comprehensive quality assurance helps prevent flaws in the way a medical device is manufactured by closely observing the entire process.

What are the different ways to validate the design? ›

Basics of Design Validation Process

Activities can include: Comparing with similar equipment performing for similar purposes. Simulating functionality through mathematical modeling. Testing the final design to prove the system operates as defined in the user needs.

What skills does a design engineer need? ›

To succeed you'll need strong technical knowledge, as well as problem solving, communication, leadership and project management skills. Depending on their specialist area, design engineers may also be known as CAD engineers, consulting engineers and product design engineers.

What qualifications do you need to be a design engineer? ›

You'll normally need a foundation degree, higher national diploma or degree to become a design engineer. You could choose from subjects like: engineering product design. industrial design.

Is being a design engineer hard? ›

High stress level. Stress level for a design engineer is usually high as compared to the average stress level for different jobs. There are always deadlines and pressure of completing the job as per requirement. Project work can call for long hours to meet deadlines.

DO-178C coding standards? ›

DO-178C is a formal process standard that covers the complete software lifecycle – planning, development and integral processes – to ensure correctness and robustness in software systems for civil airborne applications.

DO-178C levels with examples? ›

Software level
LevelFailure conditionWith independence
ACatastrophic30
BHazardous18
CMajor5
DMinor2
1 more row

What is Dal in aerospace? ›

Based on their safety criticality, different parts of the aircraft are designated different Design Assurance Levels, or DALs for short (Figure 1). A system that is highly critical will receive a higher DAL, with DAL A reserved for the most critical systems.

What are the 4 types of quality assurance? ›

The four types of quality control are process control, acceptance sampling, control charts, and product quality control.

What are 4 points of quality assurance? ›

The 4 stages in the quality assurance process are: Plan, implement, check, and adjust.

What are the 4 steps in quality assurance? ›

This cycle for quality assurance consists of four steps: Plan, Do, Check, and Act. because it analyzes existing conditions and methods used to provide the product or service customers.

What is design quality assurance in medical devices? ›

Quality Assurance (QA)

It's the job of a QA expert team to maintain these processes to ensure high-quality products are delivered. Talking about medical devices, comprehensive quality assurance helps prevent flaws in the way a medical device is manufactured by closely observing the entire process.

What are the different ways to validate the design? ›

Basics of Design Validation Process

Activities can include: Comparing with similar equipment performing for similar purposes. Simulating functionality through mathematical modeling. Testing the final design to prove the system operates as defined in the user needs.

What is quality assurance in healthcare? ›

Definition. The term "Quality Assurance" refers to the identification, assessment, correction and monitoring of important aspects of patient care designed to enhance the quality of Health Maintenance Services consistent with achievable goals and within available resources.

Is design control part of QMS? ›

Design controls are just one part of your overall quality management system (QMS). The right system will account for design controls, risk management, document control and records management, and supplier management.

How do you design a device? ›

Here's how to design the electrical components that will get your device up and running.
  1. Concept, Research and Pre-Design. ...
  2. Circuit Design. ...
  3. PCB Design. ...
  4. PCB Prototyping. ...
  5. Microcontroller Programming. ...
  6. Design Review and Testing. ...
  7. Enclosure Prototyping and Manufacturing. ...
  8. Documentation and Manufacturing.
2 Mar 2020

What is a good example of design validation? ›

If for example we imagine to have a product which is only constituted by software (the so-called, SAMD, Software as Medical Device), design validation means demonstration that we call Global System Requirements (that include user needs) are fulfilled.

What is design verification testing? ›

Design Verification is a method to confirm if the output of a designed software product meets the input specifications by examining and providing evidence. The goal of the design verification process during software development is ensuring that the designed software product is the same as specified.

What is design validation plan? ›

What Is A Design Validation Plan? The Design Validation Plan lists methods used to ensure the Product Requirements have been properly specified so that the product meets Customer Needs. There are many types of design validation including product testing, market studies and calculations.

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