Be an early applicantLess than 25 applicants
Sunrise Systems, Inc. · 3 days ago
Verification and Validation Engineer
Marlborough, MA
Full-time
Onsite
Entry, Mid Level
5+ years exp
Wonder how qualified you are to the job?
Maximize your interview chancesIT Services and IT Consulting
Insider Connection @Sunrise Systems, Inc.
Responsibilities
Write test protocol, setup design of experiments, execute tests, analyse results and document report for design verification and validation activities with focus on quality, compliance and execution rigor.
Derive test requirements from the specifications, define test plan and methodology, estimate effort and resources plan to cover design verification and validation campaign.
Establish acceptance criteria, sampling size, assess through modelling or qualitative/quantitative testing, evaluate the performance according to URS, SRS (design inputs and outputs).
Develop good practice guidelines for performing disposables kit verification and validation activities and organize standardization and harmonization within the R&D disposables team.
Mitigate project technical risks, resolve issues, deliver on-time and communicate effectively.
Qualification
Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.
Required
Master’s degree or equivalent in related engineering fields (mechanical, materials...)
Minimum 5 year-experience in designing, developing and manufacturing plastic disposable kit products for regulated industry (medical device, class II and/or class III)
Well-founded knowledge and practical experience of relevant regulations (ISO13485, FDA 21 CFR Part 820), specifically for the US and European market product submission
Demonstrated experience in defining and managing verification and validation plan, execution, statistical data analysis and report
Experience in verification activities related to disposable kits for medical device application associated to manufacturing processes as injection molding, compression molding, tube extrusion, thermoforming, heat staking, ultrasonic welding, laser welding, snap-fitting, UV gluing, solvent bonding
Strong organizational and communication skills in multisite, multidisciplinary, multicultural matrix organization
Fluent in written and spoken English
Self-starter, hands-on, creative problem solver and solution developer when presented with conflicting requirements, business demands and technical risks/issues
Company
Sunrise Systems, Inc.
Sunrise Systems was founded in 1990 with a clear vision to deliver world-class staffing service solutions in all labor categories, including IT consulting and solutions; all with the commitment to provide service that exceeds expectations and become the most trusted name in the industry.
501-1,000 employees
H1B Sponsorship
Sunrise Systems, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Trends of Total Sponsorships
2022 (13)
2021 (1)
2020 (2)
Funding
Current Stage
Late StageLeadership Team
Ruchi Hajra
Senior Account Manager/Client Servicing/Talent Acquisition Partner
Company data provided by crunchbase
