26 applicants

Company

Original Job Post

Compunnel Inc. · 3 days ago

Senior Validation Engineer

Marlborough, MA

Contract

Onsite

Senior Level

5+ years exp

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IT Services and IT Consulting

H1B Sponsorship

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Hiring Manager

Megha Rathor

Insider Connection @Compunnel Inc.

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Responsibilities

Write test protocols, set up design experiments, execute tests, analyze results, and document reports for design verification and validation activities with a focus on quality, compliance, and execution rigor.

Derive test requirements from specifications, define test plans and methodologies, estimate effort, and resource plans to cover design verification and validation campaigns.

Establish acceptance criteria, sampling sizes, assess through modeling or qualitative/quantitative testing, and evaluate performance according to URS, SRS (design inputs and outputs).

Develop good practice guidelines for performing disposable 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.

ManufacturingMedical devicesISO13485FDA 21 CFR Part 820ValidationStatistical data analysisInjection moldingCompression moldingTube extrusionThermoformingHeat stakingUltrasonic weldingLaser weldingSnap-fittingUV gluingSolvent bonding

Required

Master’s degree or equivalent in related engineering fields (mechanical, materials, etc.)

Minimum 5 years of experience in designing, developing, and manufacturing plastic disposable kit products for regulated industries (medical devices, class II and/or class III)

Well-founded knowledge and practical experience of relevant regulations (ISO13485, FDA 21 CFR Part 820), specifically for US and European market product submission

Demonstrated experience in defining and managing verification and validation plans, execution, statistical data analysis, and reporting

Experience in verification activities related to disposable kits for medical device applications associated with manufacturing processes such as injection molding, compression molding, tube extrusion, thermoforming, heat staking, ultrasonic welding, laser welding, snap-fitting, UV gluing, and solvent bonding

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)