Be an early applicantLess than 25 applicantsPosted by Agency
TalentBurst, an Inc 5000 company ยท 3 days ago
Validation Engineer
Marlborough, MA
Contract
Onsite
Mid, Senior Level
5+ years exp
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Hiring Manager
Neha Dobal
Insider Connection @TalentBurst, an Inc 5000 company
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 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
TalentBurst, an Inc 5000 company
Founded in 2002, TalentBurst is a certified MBE firm that provides award winning solutions globally including: IT/Eng, Prof, & F&A Staffing Life Sciences & Clinical Staffing SLED (State, Local, Education) Staffing High Hazard & Global Payroll 1099/IC Validation & Compliance Recognitions & awards include: 2023 Top Workplaces Best Place to Work 2023 Top Workplaces Culture Excellence 2023 World Staffing Summit Top 100 Staffing Firms to Work For 2023, 2022 SIA Diverse Owned Staffing Firms 2021 BBJ #1 Largest MBE Enterprise in MA 2020-2021 BBJ Fast50 2020 SIA Large Life Sciences Staffing Firms 10 time BBJ Pacesetter & INC 500/5000 5 time SIA-fastest growing GNEMSDC Supplier of Year Category 4 2019-2020 AgileOne Diverse Supplier of the Year 2021 AgileOne Gold Supplier 2017 Allegis Global Solutions Strategic Partner 2018-2023 Allegis Global Solutions Diversity Partner of the Year 2020 Coupa Advantage and Link Silver Partner Magnit Global Supplier Excellence 2023 PRO Unlimited Silver, Gold, & Platinum Supplier 2012-2020 PRO Unlimited VOP Supplier of the Year 2020 Randstad Premier Supplier 2021-2023 TAPFIN Premier Partner 2017-2018 Workforce Logiq Proven Performer 2016-2020 First Data #1 supplier for 12 Quarters Thermo Fisher Supplier of the Quarter Toyota Best in Compliance & Retention Excellence Dominion Energy Supplier of the Year 2020 Western Union Supplier of the Year 2017 Top Supplier for PerkinElmer, VISA, Mass Mutual, and more! We currently have workforce in 46 states & 12+ countries for customers such as Amazon, Apple, VISA, Exelon, Securian, Salesforce, Dropbox, Twitter, Otsuka, Adobe, Western Union, First Data, FIS, SANOFI, Merck, Abbott, Roche, Dell, and Corning among many others.
1,001-5,000 employees
H1B Sponsorship
TalentBurst, an Inc 5000 company 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 (5)
2022 (1)
2021 (1)
2020 (2)
Funding
Current Stage
Late StageLeadership Team
Jamie Jacobs (she/her)
Sr Vice President of Strategic Partnerships and DE&I/ESG Council
Recent News
The Swellesley Report
2023-12-24
2023-12-24
Company data provided by crunchbase
