Design Control & Quality Systems Engineer
Description :
Coordinate design Assurance activities in support of product development and life cycle processes between customer team and offshore team
- Good Understanding of ISO 13485 Quality System Standards, FDA Quality System Regulations, ISO 14971, IEC 62366 and / or other international medical device standards
- Advanced Technical Training in Quality Engineering principles, Risk Management, Ophthalmic Sciences and Technology, Systems Engineering and / or Process Excellence (Certified Six Sigma Black Belt) is preferredResponsibilities :
- Responsible for developing / updating quality plan
- Prepare, execute, review and approve design verification test protocols and reports
- Determine statistically relevant sample sizes
- Able to lead risk management activities including creation / update of Risk Management Plan, Hazard Analysis, Design FMEA, Risk Benefit Analysis and Risk Management Final Report
- Creating appropriate harm / hazard analysis / health hazard assessment for issues potentially impacting patient outcomes
- Investigate, identify and implement corrective and or preventive actions to close design control CAPAs
- Assess design control procedure updates and determine product and business impact
- Lead projects related to major design control upgrades
- Engaging with project teams to gather and incorporate feedback to improve design control
- Prepare technical product documentation including design history files, drawings, bills of materials, test protocols and reports, engineering change orders (ECO), etc.
- Work with manufacturing engineer / process engineer to ensure necessary process controls are in place
- Work with manufacturing engineer / process engineer during process validation execution and protocol and report review and approval
- Assess impact of validations on SOPs, process sheets, FMEAs and Quality Control PlansQualifications : oBS or MS degree (Mechanical, Biomedical Engineering, or related technical field)oProject management experience is requiredoMinimum (6-8 years) of Quality experience in medical device industryoASQ Certification as a Quality Engineer is preferred
Sr Principal Design Engineer – SoC Systems
The CSG Central Applications Engineering team seeks an experienced SoC design engineer to integrate and support Cadence IP products in system reference designs. The Cadence Compute Systems Group (CSG) develops and licenses IP designs for SoC and ASIC systems. This Systems CAE will use advanced syste...
Control Design Engineer
Calling Talented Controls Design Engineers!. Offering comprehensive services, from engineering applications and automated control systems to sustainable maintenance and retro-commissioning. Gain practical experience in controls project design, material selection, and sequence of operations developme...
Principal Product Engineer - DisplayPort Domain (R45204/sa)
The company applies its underlying Intelligent System Design strategy to deliver software, hardware and IP that turn design concepts into reality. Cadence customers are the world’s most innovative companies, delivering extraordinary electronic products from chips to boards to systems for the most dy...
Senior Quality Engineer Electromechanical Systems
Senior Quality engineer will provide expertise and guidance to the team on design control and risk management, Software Development Life Cycle, and Design for Reliability and Manufacturing. In addition, this position will play an effective role to ensure that the developed products meet quality stan...
Digital IC Implementation, Principal Application Engineer
BS degree Computer Science/Engineering, Electrical, Engineering, or related field8+ years of design/EDA experienceStrong knowledge in Digital Design Fundamentals, Semiconductor fundamentals, and Static Timing Analysis is requiredPrior experience with IC digital implementation flows and backend EDA t...
Systems Design Engineer (optical systems, vacuum systems)
Enabling the movement towards advanced chip design, KLA's Global Products Group (GPG), which is responsible for creating all of KLA's metrology and inspection products, is looking for the best and the brightest research scientist, software engineers, application development engineers, and senior pro...
Lead IC Digital Implementation Application Engineer
We are excited to welcome highly talented hardware designers and application engineers to join our Cadence North America Field Applications Team. With your expertise, you'll help them deploy Cadence’s market-leading technologies in Synthesis, P&R, and Signoff to meet/exceed their PPA targets, achiev...
Wireless Systems Design and Integration Engineer
Do you love working on challenges that no one has solved yet? Do you like changing the game? We have an opportunity for a forward-thinking and unusually hardworking Wireless System Engineer, working on both design and integration as part of your growth. In this technical role, you will be responsibl...
Sr Staff Systems Engineer (Server Farm)
Role: Sr Staff Systems Engineer. Cadence is seeking a Server Farm Engineer to join our team to support, manage, and improve the compute farm environment. ...
Sr. Systems Design Engineer (Physics/Optics)
We are looking for an experienced, dedicated and creative Experimental Physicist/ System Design Engineer! You will be part of our Research and Development of a novel metrology technologies for film stacks and critical dimensions measurements. You will develop optical systems from the stage of basic ...