Design Quality Engineer I

Note: W2 requirement

Job Description

The Design Quality Engineer I will be responsible for developing quality assurance documentation to support new product development and regulatory submissions. This role requires maintaining the quality system for the design control process by identifying and correcting deficiencies in procedures and practices. The engineer will engage in design, development, manufacturing, and risk management activities for new product development projects, ensuring efficient testing practices and supporting the definition of design verification and validation test requirements.

Responsibilities

• Develop quality assurance documentation for new product development and regulatory submissions.
• Maintain quality system for design control by identifying and correcting deficiencies.
• Engage in design, development, manufacturing, and risk management activities.
• Participate in design reviews, identifying risks and tracking mitigation measures.
• Define design verification and validation test requirements and complete reports with statistical validity.
• Support Advanced Operations in developing manufacturing processes for new products.
• Utilize statistical analysis and problem-solving techniques to determine product acceptance limits and resolve quality issues.
• Develop, review, and approve inspection plans, routers, and product drawings.
• Support product design transfers to manufacturing facilities.
• Evaluate predicate products for relevant quality issues impacting new product development.
• Analyze and define critical quality attributes through risk analysis techniques.
• Collect initial market feedback and address early concerns.
• Lead risk management activities by developing risk management plans and conducting risk reviews.

Essential Skills

• Experience with medical device product development lifecycle, including risk management and design/process verification and validation
• Applied knowledge of Advanced Quality tools such as Failure Modes Effect Analysis (FMEA), GD&T, Root Cause Analysis, and Mistake Proofing/Poke Yoke.
• Ability to read and interpret CAD drawings.
• Experience interacting with regulatory agencies (FDA, MoH, TUV, etc.).
• Thorough knowledge of US and International Medical Device Regulations.
• Strong project management skills and ability to manage multiple tasks.
• Advocacy for product excellence and quality.
• Ability to work cross-functionally with departments such as Advanced Operations, Product Development, Regulatory Affairs, and Marketing.
• Strong interpersonal, written, oral communication, and negotiation skills.
• Critical and 'outside the box' thinking.
• Problem-solving and analytical skills.
• Ability to manage and complete projects in a matrix organization.
• Ability to work independently.
• Experience in compliance risk situations.
• Computer literacy, including proficiency with Mini-Tab or similar analysis programs.

Additional Skills & Qualifications

• Strong knowledge of Quality Concepts such as CAPA, Audits, and Statistics.
• Demonstrated ability to effectively manage multiple tasks simultaneously.
• Demonstrated ability to advocate for product excellence and quality.
• Strong interpersonal skills and ability to work cross-functionally.