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LanceSoft, Inc. · 3 days ago
Test Method Validation Engineer
Marlborough, MA
Full-time
Onsite
Mid, Senior Level
$71/hr - $74/hr
5+ years exp
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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
LanceSoft, Inc.
Established in 2000, LanceSoft is a Certified MBE and Woman-Owned organization, and a pioneer in providing premium end-to-end Global Workforce Solutions and IT Services to diverse clients across various domains.
1,001-5,000 employees
H1B Sponsorship
LanceSoft, 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
2023 (20)
2022 (22)
2021 (46)
2020 (69)
Funding
Current Stage
Late StageLeadership Team
Ram Karuppusamy
Chairman & CEO
Simon Dealy
Chief Financial Officer
Company data provided by crunchbase
