Design Engineer

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.