Senior Design Assurance Engineer (NPI) - can be remote - Danbury, Connecticut United States - 38122
Senior Design Assurance Engineer (NPI) - can be remote
Danbury, Connecticut - United States
$80,000.00 - $130,000.00 - US Dollars - Yearly
Employer Will Recruit From:
WHY IS THIS A GREAT OPPORTUNITY?
Can be done remotely - can travel to manufacturing site one a month for a few days.
Growing & Profitable $4B Medical Device Manufacturer seeking talented Senior Design Assurance Engineer for one of their large manufacturing sites. This position will be responsible for working with New Product Introductions for one of their division. This is a senior role, looking for some with experience in doing this for another company. Great work environment! Come be a part of a strong, intellectually curious learning team that supports New Productions Introduction.
Opportunities for growth!
BS degree in Technical degree (engineering, sciences, etc.)
Must have 5+ years of design quality assurance (working on NPI) in a FDA regulated industry, preferably Medical Device Manufacturing
R&D Engineering or Quality Engineering Experience is a plus
Must have strong knowledge of FDA Quality System Regulations, ISO 13485, etc.
Working knowledge of ISO 14971, risk evaluation techniques, FMEA, fault tree analysis or HACCP
Must have experience with reliability analysis, test methods, and test method validation
Working knowledge of IEC60601, IEC62366, EN62304
Must be skilled in test plan development and root cause failure analysis and working knowledge of supplier quality management.
Strong verbal and written communication skills especially technical report writing.
Must excel at strong collaboration, and working with cross functional teams (project teams), including taking leadership role in critical tasks to assure appropriate and timely completion/resolution
Ability to appropriately assess written design and device documentation as the principle advocate for compliance
Compensation appropriate for experience level ($80-130k base, bonus,) This role can be done remotely if willing to travel once a month to manufacturing site for a few days
University - Bachelor's Degree/3-4 Year Degree