Principal Design Quality Engineer

POSITION SUMMARY:

The Principal Design Quality Engineer (PDQE) is accountable for leading and supporting key strategic projects, new product development and provides quality oversight to the Research & Development (R&D) organization while working within a multi-functional team environment for medical devices. The PDQE will handle projects and tasks, from product inception through design transfer and play an active role to ensure products meet quality standards consistent with internal procedures and acceptance criteria, while meeting all design control and other regulatory requirements. The PDQE shall have prior experience working within an FDA compliant Title 21 section 820 environment and the ability to work cross-functionally to support rapid growth and continuous improvement.

PRIMARY DUTIES AND RESPONSIBILITIES:

• Leads new product qualification activities for new products and supports product transfer activities to current and new suppliers.
• Provides Quality oversight and approval of qualification/validation/design control activities.
• Liaison with supplier quality representatives concerning issues with quality assurance.
• Leads and supports in the creation of inspection models, inspection prints, gauging, or other inspection documents and detailed testing requirements to insure receipt of quality product.
• Leads and supports in the creation and maintaining product and process risk management files to meet FDA and ISO standards.
• Evaluates product changes and directs appropriate disposition of product through the company’s change control system.
• Participates in quality system audits (FDA, ISO, Internal, etc.) R&D and training cadaver labs.
• Collaborates with Surgeon Advisory Board, Marketing, and Design Engineers on new product feasibility to understand product needs and formulate design inputs.
• Provides technical guidance to project teams related to product testing, verification, validation, risk analysis, and design requirements.
• Review and assess the quality and technical rigor for manufacturability (DFM) of new product designs.
• Organize and lead project design reviews.
• Support concurrent engineering efforts as a participating design team member for product development projects representing quality assurance and the customer (supplier and end user)

Requirements

• Bachelor’s degree in engineering, Science, Technology, or a related discipline
• Minimum of seven years (7+) of progressive medical device engineering experience in Quality, Development, and Manufacturing. Orthopedic medical device experience preferred.
• Familiarity working within an FDA compliant Title 21 section 820 environment.
• Certified Quality Engineer preferred.

Additional information

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