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Compunnel Inc. · 3 days ago
Validation Engineer
Marlborough, MA
Contract
Onsite
Senior Level
5+ years exp
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Hiring Manager
Parag Patel
Insider Connection @Compunnel Inc.
Responsibilities
Develop test protocols and design experiments to verify and validate product designs.
Execute tests according to defined protocols, analyze results, and document comprehensive reports.
Derive test requirements from specifications, define test plans, methodologies, and resource requirements.
Establish acceptance criteria, sampling sizes, and assess performance through quantitative and qualitative testing methods.
Ensure alignment with User Requirement Specifications (URS) and System Requirement Specifications (SRS).
Develop guidelines for verification and validation of disposable kits, promoting standardization within the R&D team.
Identify and mitigate technical risks, resolve issues, and deliver projects on time.
Communicate effectively across multidisciplinary teams and sites.
Qualification
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Required
Master’s degree or equivalent in mechanical engineering, materials science, or related fields.
Minimum 5 years of experience in designing, developing, and manufacturing plastic disposable kit products within the medical device industry (Class II and/or Class III).
Deep understanding and practical application of relevant regulations (ISO13485, FDA 21 CFR Part 820) for product submissions in US and European markets.
Proven experience in defining and managing verification and validation plans, executing tests, conducting statistical analysis, and preparing detailed reports.
Expertise in verification activities related to manufacturing processes such as injection molding, compression molding, extrusion, thermoforming, and assembly techniques (e.g., heat staking, ultrasonic welding, laser welding).
Strong organizational and communication skills, adept at working in a multicultural, matrix organizational structure.
Fluent in written and spoken English.
Self-motivated, proactive, and capable of solving complex problems and resolving conflicts between business requirements and technical constraints.
Company
Compunnel Inc.
Founded in 1994, Compunnel Inc.
1,001-5,000 employees
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)
Funding
Current Stage
Late StageLeadership Team
Andy Gaur
Founder, Chairman & CEO
Karthik Natarajan
Executive VP & CTO
Company data provided by crunchbase
