Mindlance · 2 days ago
Engineer - Degreed V_SJM
Pleasanton, CA
Full-time
Onsite
Senior Level
5+ years expMindlance is a company seeking a Sr. Development Quality Engineer to provide design quality expertise to their product development team. The role involves leading Design Control deliverables, supporting product requirements, and ensuring compliance with regulatory requirements for medical devices.
Human Resources
Responsibilities
Lead and/or support on-time completion of Design Control deliverables
Support the establishment of objective, measurable, and verifiable product requirements
Support Design Verification and Validation planning & execution, including any cross-functional investigation & resolution activities
Lead Risk Management activities from product concept through commercialization
Support test method development and lead test method validation activities
Support manufacturing process development & qualification for new product and design changes
Support the establishment of component specification definitions, supplied component sampling plan development, and vendor qualifications
Support biocompatibility and sterilization qualifications
Support audits and quality system improvement activities
Support Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and regulatory requirements
Comply with Client, U.S. FDA, EUMDR and other requirements, as applicable
Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and suppliers
Qualification
Required
Bachelor's degree in Engineering or Technical Field
Minimum of 5 years of experience in R&D, Process/Manufacturing Engineering, and/or Quality with at least 2 years supporting product development
Experience in medical devices and associated regulations/standards
Experience in test method development and validation
Experience in preparing risk assessments, FMEA and other risk documents
Preferred
Advanced Degree in Engineering/Technical Field
Experience in active implantable medical devices
Knowledge of requirements management tools (e.g., DOORS) and use of problem reporting systems (e.g., JIRA)
Working knowledge of statistics and its application to verification and validation?
Company
Mindlance
Mindlance is a Staffing and Recruiting company which provides multi-vertical staffing services
1001-5000 employees
H1B Sponsorship
Mindlance 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
Represents job field similar to this job
Trends of Total Sponsorships
2025 (71)
2024 (53)
2023 (37)
2022 (72)
2021 (36)
2020 (40)
Funding
Current Stage
Late StageLeadership Team
R
Rajat Paul Dhall
Co-Founder & Managing Director
V
Vik Kalra
Co-Founder and Managing Director
Recent News
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