Design Quality Assurance Engineer

Novocure • Portsmouth, NH

265d

About The Position

The Design Quality Assurance Engineer supports Novocure's medical device product development activities by providing a technical review of design input requirements, design descriptions, and other product design and test documentation. This position involves frequent communication and coordination with Project Management, engineering and quality team members in Portsmouth NH, Switzerland, and Israel. This is a full-time, exempt, hybrid role tied to the Portsmouth, NH office, reporting to the Senior Design Quality Assurance Engineer.

Requirements

• BS in engineering or other scientific discipline and 2-7 years of related experience, or MS in engineering or other scientific discipline and 2-5 years of related experience
• At least 1 year of experience in medical device product development - preferably
• Demonstrated technical writing skills
• English language mastery and fluency
• Experience with risk analysis and risk management
• Experience writing and reviewing design input requirements
• Experience writing and reviewing design verification and validation protocols
• Critical thinking and decision-making, including the ability to recognize when to ask questions
• Must have good written and oral communication skills
• Highly organized and strong attention to detail
• Familiarity with Quality System Regulation, Medical Device Regulation, ISO 13485, and ISO 14971
• Able to work in a team environment and execute responsibilities with some direct supervision

Responsibilities

• Provide advice, guidance, and training as needed to ensure product realization activities and documentation meet quality system requirements
• Review engineering and test documents to ensure they meet Novocure quality system requirements consistent with applicable regulations, standards, and guidance
• Provide constructive feedback to improve design and test documentation
• Participate in product and process risk analysis activities, including any needed support of the product risk management lead
• Collaborate in requirements development and derivation
• Participate in corrective and preventative action activities
• Participate in design reviews

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Professional, Scientific, and Technical Services
• Education Level: Bachelor's degree