Design Assurance Engineer Job Description (2024)

Design Assurance EngineerJob Description

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

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

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

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

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

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

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

• 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