Title: Design Assurance Engineer
Duration: 12 Months
Location: Plymouth, MN – 55442
100% Onsite position
Start date beginning of January after shutdown
Core Technical Skills
- Educational Background: Degree in Biomedical Engineering, Mechanical Engineering, or a related field.
- Experience: 2-4 years in design assurance, quality engineering, or a similar role within the medical device industry.
- Regulatory Knowledge: Familiarity with FDA regulations, ISO 13485, and other relevant standards.
- Technical Proficiency: Skills in risk management, design verification and validation, and statistical analysis.
Technical Skills
- Statistical Knowledge: Basic proficiency in statistical analysis software (e.g., Minitab, JMP). Especially as related to design verification.
- Failure Analysis: Skills in root cause analysis and problem solving. Able to work quickly to identify solutions and work within a project team to keep a project schedule on track.
Quality and Compliance Tools
- Quality Management Systems (QMS): Experience with QMS software (e.g., On Base, EPIQ)
- Risk Management: Skills in risk assessment tools and methodologies (e.g., ISO 14971, FMEA, hazard analysis).
- Design Controls: In-depth understanding of design control processes.
Testing and Validation
- Test Method Development: Ability to develop and validate test methods.
- Reliability Testing: Experience with reliability testing techniques.
- Inspection Method Validation: Skills in validating inspection methods to ensure accuracy and reliability.
Specific Software Familiarity
- Windchill: Experience with Windchill for product lifecycle management (PLM).
Problem-Solving and Analytical Skills
- Critical Thinking: Ability to analyze complex problems and develop effective solutions.
- Attention to Detail: Precision in reviewing design documents and identifying potential issues. Ability to draft high quality verification protocols and other quality system documentation in line with medical device quality system requirements.
- Data Analysis: Proficiency in using tools and software for data analysis and interpretation.
Communication and Interpersonal Skills
- Team Collaboration: Experience working in cross-functional teams and the ability to communicate effectively with engineers, designers, and regulatory professionals. Able to share project risks effectively to teams to drive focus on results.
- Documentation Skills: Strong ability to document processes, test results, and compliance reports clearly and accurately.
- Presentation Skills: Ability to present findings and recommendations to stakeholders in a clear and concise manner.
Project Management
- Time Management: Ability to manage multiple projects and meet deadlines.
- Organizational Skills: Strong organizational skills to keep track of various tasks and documentation. Ability to use Microsoft Project is a nice to have.
- Adaptability: Flexibility to adapt to changing project requirements and regulatory updates.
Nice to Have
- Material Science: Understanding of biomaterials and their properties.
- Biomechanics: Knowledge of biomechanics for device compatibility.
