Design Quality Assurance Engineer

Novocure Inc; South Windsor (NH, CT); On-site; USD 70,000 - 95,000; Full time

Job summary

An innovative firm is seeking a Design Quality Assurance Engineer to support medical device development. This hybrid role involves collaboration with teams in multiple locations, ensuring compliance with quality standards and regulations. The ideal candidate will possess strong technical writing skills and experience in risk analysis. Join a passionate team dedicated to making a difference in cancer treatment and be part of a mission that prioritizes patient outcomes through innovative therapies. This is a fantastic opportunity for those looking to contribute to impactful projects in a supportive environment.

Qualifications

• 2-7 years of experience in engineering or related field.
• Experience in medical device product development preferred.

Responsibilities

• Provide guidance to ensure quality system requirements are met.
• Review engineering documents for compliance with regulations.

Skills

Technical Writing

Risk Analysis

Communication Skills

Critical Thinking

Education

BS in Engineering

MS in Engineering

Tools

ISO 13485

ISO 14971

Job description

Description:

JOB SUMMARY:

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 a Principal 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


• Participate in design reviews

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- 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

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.

ABOUT NOVOCURE:

Our vision

Patient-forward: aspiring to make a difference in cancer.

Our patient-forward mission

Together with our patients, we strive to extend survival in some of the most aggressive forms of cancer by developing and commercializing our innovative therapy.

Our patient-forward values

- innovation

- focus

- drive

- courage

- trust

- empathy