Be an early applicantLess than 25 applicantsPosted by Agency
Abacus Service Corporation · 2 days ago
Validation and Verification Engineer
Marlborough, MA
Contract
Onsite
Senior Level
$65/hr - $74/hr
5+ years exp
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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, focusing 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 size, and assess through modeling or qualitative/quantitative testing, evaluating performance according to URS, SRS (design inputs and outputs).
Develop best 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, etc.)
Minimum 5 years of experience in designing, developing, and manufacturing plastic disposable kit products for regulated industries (medical device, Class II and/or Class III)
Strong knowledge and practical experience with relevant regulations (ISO13485, FDA 21 CFR Part 820), specifically for US and European market product submissions
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
Strong organizational and communication skills in a 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
Preferred
Ability to Commute: Marlborough, MA (Preferred)
Willingness to travel: 25% (Preferred)
Benefits
401(k)
401(k) matching
Dental insurance
Health insurance
Life insurance
Paid time off
Vision insurance
Company
Abacus Service Corporation
Abacus Service Corporation is provides IT solutions for global health care businesses.
201-500 employees
H1B Sponsorship
Abacus Service Corporation 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 (2)
2022 (2)
2021 (3)
2020 (4)
Funding
Current Stage
Growth StageLeadership Team
S
Sam Akunuri
Founder and COO
Company data provided by crunchbase
