Qualifications

• Bachelor's degree in life sciences, material sciences, engineering, or a related field required.
• Experience in the medical device industry required; minimum 3 years preferred.
• Working knowledge of design controls and general familiarity with ISO 13485 standards; formal ISO 13485 training is a plus.
• Experience in a small company or start-up environment preferred.
• Familiarity with QMS support software/document control systems is a plus.

Responsibilities

• Lead and implement product development using design controls for new products and changes.
• Create and manage the design history file (DHF) with detailed specifications.
• Plan and execute design verification and validation studies with related protocols.
• Oversee manufacturing documentation and process validation activities.
• Manage risk from product concept through commercialization.
• Collaborate with Regulatory to support submissions for pre-market authorizations in the US.
• Coordinate with contract manufacturers to ensure quality and performance requirements are met.

Benefits

• Dynamic work environment with opportunities for growth in a small company setting.
• Exposure to various stages of product development in the medical device industry.
• Collaboration with regulatory and manufacturing partners.
• Focus on continuous quality improvement and process optimization.