Senior Design Assurance Engineer
This Quality Design Assurance Engineer role will focus on design assurance supporting product and process development to ensure a successful production launch and delivery of the highest quality product to the customer.
This position also supports design change and other quality initiatives. This position interacts closely with the Engineering team as well as Operations, Quality Systems, Quality Assurance, Marketing, and Regulatory.
This position is responsible for complying with the Quality Management System requirements and carrying out responsibilities as outlined in the environmental, health, and safety policies.
Responsibilities :
- Execute and support completion of product and process development tasks.
- Create and ensure completeness, accuracy, and compliance of DHF and DMR.
- Support development and maintenance of customer requirements, product specifications.
- Collaborate cross-functionally to lead and support completion and maintenance of product risk management tasks.
- Author design verification and validation plan and report documents.
- Support development of manufacturing processes, equipment, and product inspection documentation.
- Author process validation plan and report documents.
- Implement appropriate sampling inspection and support qualification activities for purchased components.
- Support design and process test and inspection method development, and lead method validation activities.
- Utilize statistical techniques to lead and support characterization, verification, validation testing, and root cause analysis.
- Lead and support completion of risk management tasks to establish and maintain safe and effective products and processes.
- Support quality system-related tasks including nonconformances and CAPAs.
Requirements :
- Bachelor of Science in Engineering
- Strong experience with Quality in the medical device industry.
- Must be able to work independently under limited supervision.
- Advanced knowledge of basic Quality Systems and good documentation practices.
- Experience in Non-Conforming Material Reporting
- Experience in investigating and implementing Corrective and Preventive Actions
- Experience in design controls, and test method and process validation
- Experience with European Medical Device Regulations, FDA 21 CFR Regulations, Australian TGA Regulations, ISO 14971, ISO 13485.
- Strong communication skills, both verbal and written.
- Comfortable working with and seeking optimum solutions with team members in adjacent disciplines of engineering.
Principal Design Assurance Engineer
In this role you will lead design assurance activities and initiatives supporting Product Development projects including establishing and improving product design requirements, design review activities, risk management and the development of testing requirements. Principal Design Assurance Engineer....
Senior Design Assurance Engineer
Senior Design Assurance Engineer . Leads design verification, design validation, usability and test method validation activities for new product development to meet or exceed internal and external requirements. Core Team member of medical device development project teams to ensure compliance to Desi...
Senior Custom Design Engineer
We engineer our connection solutions to improve the overall functionality and design of equipment and processes for the life sciences, industrial, and chemical handling markets. Custom Design Engineer will allow you to serve staff and leaders and help provide creative solutions to drive CPC's short...
Senior Quality Assurance Engineer
The Senior Quality Assurance Engineer will play a pivotal role in ensuring the quality and reliability of our products and services while leading a team of quality assurance professionals. Senior Quality Assurance Engineer . Senior Quality Assurance Engineer. Establish quality assurance metrics, KPI...
Senior or Principal Engineer: Transportation/Traffic Design Project Manager
Do you have a strong background in civil engineering with a focus on multimodal traffic and safety analysis and/or traffic-related final design items such as traffic signal design, lighting design, and signing/pavement marking design? Do you desire to be a part of a collaborative preliminary design ...
Senior ASIC Design Verification Engineer
Senior ASIC Design Verification Engineer. Developing architectures and specifications for complex design blocks and SOCs. Implementing complex digital designs using reusable RTL methods (Verilog, VHDL, SystemVerilog). Complex computational architectures and algorithms, such as multi-rate/DSP and µP ...
Senior Engineer - Transportation Design/Build
Braun Intertec is seeking a Senior Engineer - Transportation Design/Build to join our St. Projects can range from foundation work to transportation projects that require bridge and retaining wall foundation recommendations, pavement design, and material disposition recommendations. Develop and maint...
Senior Design Engineer
You will mentor and coach other Design Engineers on the creation of all computer engineered specifications and instruction manuals for prototype and production purposes, as well as completes design specifications in this role. The Senior Design Engineer needs have a strong understanding of the visua...
Principal Design Assurance Electrical Engineer (Sustaining)
The Principal Design Assurance Engineer (sustaining) will be responsible for leading, supporting and maintaining the design lifecycle of image guided therapy consoles (both hardware and software). Principal Design Assurance Electrical Engineer (Sustaining). Principal Design Assurance Engineer (San D...
Senior Analog IC Design Engineer
Significant industrial experience in both AMS and RF design . Demonstrated deep understanding and prior experience in custom IC design for various analog and RF blocks and chips . Proficient with all required design tools such as ADS, HFSS, Cadence Virtuoso etc. Low-speed, low-noise, high-precision ...