Design Assurance Engineer

Title: Design Assurance Engineer

Duration: 12 Months

Location: Plymouth, MN – 55442

100% Onsite position

Start date beginning of January after shutdown

Core Technical Skills

1. Educational Background: Degree in Biomedical Engineering, Mechanical Engineering, or a related field.
2. Experience: 2-4 years in design assurance, quality engineering, or a similar role within the medical device industry.
3. Regulatory Knowledge: Familiarity with FDA regulations, ISO 13485, and other relevant standards.
4. Technical Proficiency: Skills in risk management, design verification and validation, and statistical analysis.

Technical Skills

1. Statistical Knowledge: Basic proficiency in statistical analysis software (e.g., Minitab, JMP). Especially as related to design verification.
2. 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

1. Quality Management Systems (QMS): Experience with QMS software (e.g., On Base, EPIQ)
2. Risk Management: Skills in risk assessment tools and methodologies (e.g., ISO 14971, FMEA, hazard analysis).
3. Design Controls: In-depth understanding of design control processes.

Testing and Validation

1. Test Method Development: Ability to develop and validate test methods.
2. Reliability Testing: Experience with reliability testing techniques.
3. Inspection Method Validation: Skills in validating inspection methods to ensure accuracy and reliability.

Specific Software Familiarity

1. Windchill: Experience with Windchill for product lifecycle management (PLM).

Problem-Solving and Analytical Skills

1. Critical Thinking: Ability to analyze complex problems and develop effective solutions.
2. 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.
3. Data Analysis: Proficiency in using tools and software for data analysis and interpretation.

Communication and Interpersonal Skills

1. 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.
2. Documentation Skills: Strong ability to document processes, test results, and compliance reports clearly and accurately.
3. Presentation Skills: Ability to present findings and recommendations to stakeholders in a clear and concise manner.

Project Management

1. Time Management: Ability to manage multiple projects and meet deadlines.
2. Organizational Skills: Strong organizational skills to keep track of various tasks and documentation. Ability to use Microsoft Project is a nice to have.
3. Adaptability: Flexibility to adapt to changing project requirements and regulatory updates.

Nice to Have

1. Material Science: Understanding of biomaterials and their properties.
2. Biomechanics: Knowledge of biomechanics for device compatibility.