Design Quality Assurance Engineer Position Available In Rockingham, New Hampshire

Location:

Portsmouth, NH, US, 03801

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 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
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

Nearest Major Market:

Portsmouth

Nearest Secondary Market:

Boston