SENIOR DESIGN ASSURANCE ENGINEER RESUME EXAMPLE

Published: October 14, 2024 - The Senior Design Assurance Engineer participates independently in new product development projects, ensuring that product inputs are clearly defined and compliant with requirements. Responsible for design verification and validation activities, including test method validation, to confirm that all standards and internal policies are met. Collaborates with R&D on risk management files and coordinates Health Risk Assessment teams, demonstrating effective analysis and customer interaction throughout the project lifecycle.

Tips for Senior Design Assurance Engineer Skills and Responsibilities on a Resume

1. Senior Design Assurance Engineer, Medtronic, Minneapolis, MN

Job Summary: 

  • Responsible for providing support to Global Quality and Operations projects: mainly manufacturing transfers within the Stryker T&E division
  • Supporting the DQA line manager in evaluating feasibility for standard/non-standard reworks across multiple international T&E manufacturing sites
  • Ensuring the highest level of quality is built into products in accordance with internal and external requirements
  • Evaluating and approving Engineering Design Change Requests.
  • Review technical documentation to support legacy care activities and eventually any regulatory submission/international registration.
  • Reviewing and approving final design verification and validation activities in collaboration with the testing laboratory and R&D Technical Office.
  • Leading risk management activities by identifying risks and how the design, labeling and manufacturing processes can help mitigating risks as far as possible.
  • Use analytical and technical skills to evaluate any design quality issue that arises and initiate appropriate corrections/ corrective actions to resolve them.
  • Design control and risk management


Skills on Resume:

  • Manufacturing Transfer Support (Soft Skills)
  • Feasibility Evaluation (Hard Skills)
  • Quality Assurance (Hard Skills)
  • Engineering Design Change Approval (Hard Skills)
  • Technical Documentation Review (Hard Skills)
  • Final Design Verification (Hard Skills)
  • Risk Management Leadership (Soft Skills)
  • Analytical Problem Solving (Hard Skills)

2. Senior Design Assurance Engineer, Stryker Corporation, Kalamazoo, MI

Job Summary: 

  • Work within the quality system and ensuring that the quality policy and company systems and procedures are complied with in line with the Medical Device Directive 93/42/EEC, Medical Device Directive 2007/47/EC, Medical Device Regulation 2017/745, FDA Quality System Regulations 21 CFR
  • Support the development / evolution of the Design Control, Risk Management and associated systems, to encompass new product development technologies.
  • Provide Design Assurance input to R&D project teams for designated projects
  • Understanding the Regulatory requirements for device developments and providing input to projects to encompass these requirements.
  • Lead in specification development in relation to design input development. 
  • Participate in the generation of Design Input / Output documents.
  • Lead the risk management activities for designated projects and design changes.
  • Analyze post-market data to identify any potential safety signals that may alter the benefit-risk assessment of product on the market
  • Update Risk Management Files 
  • Conduct remediation activities on existing Risk Management Files to ensure compliance with ISO 14971
  • Development of PSURs in preparation for the EU MDR Transition
  • Product development project management


Skills on Resume:

  • Quality System Compliance (Hard Skills)
  • Design Control Development (Hard Skills)
  • Design Assurance Input (Soft Skills)
  • Regulatory Requirements Understanding (Hard Skills)
  • Specification Development (Hard Skills)
  • Risk Management Leadership (Soft Skills)
  • Post-Market Data Analysis (Hard Skills)
  • Project Management (Soft Skills)

3. Senior Design Assurance Engineer, Boston Scientific, Marlborough, MA

Job Summary: 

  • Participate independently on new product development project, assuring product inputs are clearly defined
  • Assuring design verification and validation activities are appropriate and compliant to confirm inputs requirements are met. 
  • Test method validation would be an element of assuring verification/validation is acceptable.
  • Participate independently in sustaining product projects, assuring project is clearly defined and stays on task
  • Confirming product inputs are continuing to be met, and necessary verification, validation, and risk management activities are completed.
  • Work collaboratively with R&D to coordinate design elements of Risk Management files for product 
  • Assure compliance with applicable standards and internal policies.
  • Independently coordinating Health Risk Assessment team when needed for evaluation of on market product, must demonstrate efficient and effective analysis of situation, including problem definition and impact.
  • Assess change requests of product for impact to design, determine supporting information required for implementation of changes.
  • Customer interaction throughout the entire project life-cycle


Skills on Resume:

  • Independent Product Development (Soft Skills)
  • Design Verification (Hard Skills)
  • Test Method Validation (Hard Skills)
  • Project Management (Soft Skills)
  • Risk Management (Hard Skills)
  • Collaboration with R&D (Soft Skills)
  • Health Risk Assessment (Hard Skills)
  • Customer Interaction (Soft Skills)
Relevant Information
Design Assurance Engineer Resume Example