Primary Talent Partners · 5 days ago

Validation Engineer

Marlborough, MA

Full-time

Onsite

Senior Level

$65/hr - $75/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 modeling 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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ISO13485FDA 21 CFR Part 820Regulatory ComplianceValidationStatistical Data AnalysisManufacturing ProcessesInjection MoldingCompression MoldingTube ExtrusionThermoformingHeat StakingUltrasonic WeldingLaser WeldingSnap-FittingUV GluingSolvent BondingMultisite CommunicationMatrix OrganizationEnglish ProficiencyProblem SolvingCommunicationOrganizational SkillsCreativity

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