Department: Quality Assurance
Reporting: QA/RA Manager


The Senior Design Assurance Engineer is an experienced Design Assurance Engineer responsible for product development activities, including; Demonstrating and promoting a commitment to improving patient safety, customer satisfaction and product quality; Understanding and complying companies quality, business, health & safety systems and market/legal regulations governing the quality systems; Removing or mitigating against risks associated with the design, use and manufacture of devices; as well as being a key player in transfer of new products from development to commercialisation and post launch.


The role of the Senior Design Assurance Engineer includes but is not limited to the following responsibilities and skill sets:

  • Managing the Design Verification and Validation function; defining verification and validation techniques, risk management, statistical techniques and compliance to regulatory requirements.
  • Responsible for the compilation of design verification/validation protocols, reports and design design/quality documentation supporting product development/sustaining engineering projects.
  • Working closely with contract manufacturer to ensure complete verification and validation for the entire design system including any subsequent design changes.
  • Management of the risk management activities.
  • Completing work assignments under limited supervision/guidance.
  • Interfacing with R&D, Regulatory Affairs, Clinical Marketing, Manufacturing in a project team environment providing technical and Quality systems input to the team.
  • Familiarity with requirements and procedures that govern the Product Development
  • Identifying and resolves moderately complex exceptions to work assignments.
  • Participating in Simulated Use/Bench Testing as part of both early development projects and during execution of design verification/validation studies.
  • Experienced in test method development and validation.
  • Excellent analytical and problem-solving abilities. Analyses, draws conclusions and makes appropriate decisions from risk management activities and test data.
  • Updating Quality policies to ensure compliance with Product Development needs and relay this information to the Product Development Group.
  • Keep abreast of changes in domestic and international Quality Systems regulations and guidelines, and advise Key staff of compliance/non-compliance with FDA requirements for Design Verification and Validation and current international regulations, policies and EC directives
  • Providing both quality and technical input to the design reviews, project development/design change plans, risk management, design verification/validation protocols and reports.
  • Availability to participate in limited travelling to meet with customers to conduct scheduled reviews.
  • Other such duties as may be assigned on behalf of the Company from time to time


  • Degree in Engineering/Science or related discipline.
  • Minimum 5 years’ experience in a relevant role in the medical device industry,
  • Advanced knowledge and experience with implementing ISO14971 Risk Management Systems,
  • Advanced knowledge and experience with medical device regulated design control systems including advanced knowledge of design verification and validation methods.
  • Highly developed written and verbal communication skills
  • Proven ability of working in a cross-functional team environment,
  • Knowledge and practical experience with the use of statistical techniques in design verification and validation,
  • Strong communication and presentation skills are desirable.
  • Thinks Critically and Makes Sound Decisions
  • Collaborates and Creates Alignment as a Team member
  • Works with transparency
To apply for this position, please send an email with your resume attached to [email protected]