Full-Time Engineer Sr. I - QA Design

• Lead design assurance efforts for new product introduction projects.
• Ensure appropriateness of documented design requirements and outputs.
• Provide leadership in understanding and implementing regulations/standards.
• Supervise and coordinate the design assurance team.
• Lead product risk assessment activities.
• Provide guidance in usability/human factors engineering principles.
• Facilitate the planning, execution, and review of verification/validation activities.
• Coordinate design assurance aspects of Design to Manufacture Transfer.
• Ensure required outputs of the design control process are met.
• Support design-related corrective and preventative activities.
• Establish and maintain Risk Management File(s).

• Bachelor’s degree in Engineering required; Biomedical, Mechanical, or Electrical Engineering degree preferred.
• 5 years design assurance/quality assurance experience in a medical device or other highly regulated industry required.

• Working knowledge of ISO and FDA design and development quality requirements.
• Technical knowledge in development methodologies, design quality analysis, and project implementation.
• Proficiency in assessing manufacturing quality requirements of new product concepts.
• Experience in DHF & Technical File structure and maintenance.
• Basic knowledge in Electro-Medical safety standards.
• Essential knowledge of Risk Management for medical devices (per ISO 14971)

• Proficiency with PC operations, and the Microsoft Office suite.
• Hands-on experience with Minitab, SAP, Codebeamer and Windchill preferred.

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