Department: Quality Assurance
Reporting: QA/RA Manager

DESCRIPTION

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.

DUTIES & RESPONSIBILITIES

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

EDUCATION/EXPERIENCE

  • 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]