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Company

Original Job Post

Compunnel Inc. · 2 days ago

Test Method Validation Engineer

Marlborough, MA

Full-time

Onsite

Senior Level

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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ManufacturingPlastic ProductsISO13485FDA 21 CFR Part 820ValidationStatistical AnalysisInjection MoldingCompression MoldingTube ExtrusionThermoformingHeat StakingUltrasonic WeldingLaser WeldingSnap-FittingUV GluingSolvent BondingMultisite ExperienceMultidisciplinary ExperienceMatrix OrganizationEnglish ProficiencyOrganizational SkillsCommunication Skills

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 such 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

Company

Compunnel Inc.

Glassdoor

4.2

Founded in 1994, Compunnel Inc.

Founded in 1994

Plainsboro, New Jersey

1,001-5,000 employees

http://www.compunnel.com

H1B Sponsorship

Compunnel 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 (1572)

2022 (2192)

2021 (2385)

2020 (2157)