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.
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
- 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