40 applicantsPosted by Agency
Integrated Resources, Inc ( IRI ) · 1 day ago
Validation Engineer
Marlborough, MA
Contract
Onsite
Senior Level
5+ years exp
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Hiring Manager
Shivi Singh
Insider Connection @Integrated Resources, Inc ( IRI )
Responsibilities
Write test protocol, setup design of experiments, execute tests, analyze 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
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Required
Master’s degree or equivalent in related engineering fields (mechanical, materials.)
Minimum 5 years-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 plans, 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
Company
Integrated Resources, Inc ( IRI )
Integrated Resources Inc.
501-1,000 employees
H1B Sponsorship
Integrated Resources, Inc ( IRI ) 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
2023 (10)
2022 (11)
2021 (17)
2020 (39)
Funding
Current Stage
Late StageRecent News
Hiring | Recruitment | Placement | Executive Job Search | Job Posting's | Talent Acquisition
2022-03-01
Company data provided by crunchbase
