28 applicants
Compunnel Inc. ยท 5 days ago
Quality Engineer II
SLC Metro Area
Contract
Onsite
Mid Level
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Hiring Manager
Chirag Soni
Insider Connection @Compunnel Inc.
Responsibilities
Apply knowledge of quality engineering principles and methods to ensure compliance with Clients Quality System and also Regulatory requirements. Focus on design control, design verification/validation, FMEA, specification development, statistical reliability, critical to quality/process control, acceptance sampling, and inspection/test methodologies
Provide assistance to subject matter experts (SME) for responsible product/project within the overall manufacturing and processing of pericardial tissue heart valve assembly, including leveraging of key knowledge of quality engineering principles
Review design changes; partner with R&D in the design of safe and effective THV devices; partner with Manufacturing Engineering to develop critical manufacturing processes and provide technical quality engineering support for pilot production of clinical devices
Optimize manufacturing processes using engineering methods (e.g., Six Sigma and LEAN methods) for design for manufacturing and for continuous process improvement. Identify opportunities for re-design/design of more complex equipment, tools, fixtures, etc. to improve manufacturing processes, and reduce risk
Develop basic experiments and tests (including writing and executing protocols) to create, validate, and improve products (including evaluation of source materials and suppliers) and manufacturing processes/methods based on engineering principles; analyze results, make recommendations, and develop reports and lead team members to drive project completion
Investigate basic manufacturing product quality and compliance issues (e.g. CAPA, NCR, audit observations) for all production processes prior to final product release based on engineering principles; analyze results, make recommendations and develop reports
Identify opportunities for design and/or manufacturing transformation in a manner that ensures product development continues to evolve and improve
Assist with developing technical content of risk management files
Assist with developing training and documentation materials for production (e.g., inspection documents) to enable the seamless knowledge transfer of project and manufacturing processes from NPD to Operations.
Qualification
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Required
Engineering degree
Engineering/Internship experience within a medical device industry or highly regulated environment
Quality Engineering experience in New Product Development.
Experience providing support for either Design Assurance, Design Controls, Verification & Validation, and/or Test Method Development
Class III new product development experience
Knowledge of and experience with Risk Management (i.e. dFMEAs and/or pFMEAs), and reviewing or updating risk management documents.
Knowledge of the Domestic and International regulatory requirements of Medical Device regulations (FDA 21 CFR 820, ISO 13485, ISO 14971, ISO 62366; and other applicable regulatory requirements)
Company
Compunnel Inc.
Founded in 1994, Compunnel Inc.
Founded in 1994
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
