Design Quality Assurance Engineer

Novocure Inc.; Portsmouth (NH); Hybrid; USD 80,000 - 100,000; Full time

Job summary

An established industry player is seeking a Design Quality Assurance Engineer to enhance medical device product development. This full-time hybrid role involves collaborating with teams across multiple locations, ensuring design and test documentation meet stringent quality standards. The ideal candidate will have a strong background in engineering, excellent technical writing skills, and a keen eye for detail. Join a forward-thinking company that values innovation and quality, and contribute to impactful projects that improve patient outcomes. If you are passionate about quality assurance in medical devices, this opportunity is perfect for you.

Qualifications

• 2-7 years of experience in medical device product development.
• Demonstrated technical writing skills and English fluency.

Responsibilities

• Review engineering and test documents for quality compliance.
• Provide guidance and training for product realization activities.

Skills

Technical Writing

Risk Analysis

Communication Skills

Critical Thinking

Attention to Detail

Education

BS in Engineering or Scientific Discipline

MS in Engineering or Scientific Discipline

Tools

ISO 13485

ISO 14971

Job description

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.

ESSENTIAL DUTIES AND 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.

QUALIFICATIONS/KNOWLEDGE:

• 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 preferred.
• 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.

OTHER:

• Ability to lift up to 20 pounds.
• Must have good written and oral communication skills.
• Highly organized and strong attention to detail.

Novocure is an Equal Opportunity Employer, including Veterans/Disabled.