Overview
Design Quality Assurance Engineer Jobs in Portsmouth, NH at Novocure
Title: Design Quality Assurance Engineer
Company: Novocure
Location: Portsmouth, NH
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
