This is Girish, - Recruitment and Resources from SancroSoft USA Inc.
We have an urgent requirement as follows:
Please respond with resumes in MS-Word Format with the following details to Girish@sancrosoftusa.com
Full Name :
Location :
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Sr. Reliability Engineer
Location: Minneapolis, MN
Duration: Long-term
Rate: Market
POSITION DESCRIPTION
· Provide reliability engineering support of implantable device..
· Provide reliability assurance of design, manufacturing, and testing of systems and components with an emphasis on electronic, mechanical, and electro-mechanical products.
· Analyse field data for product improvement opportunity.
DESIRED/PREFERRED QUALIFICATIONS
· Working knowledge of FDA Quality System Regulations, Medical Device Directive, ISO 13485, ISO 14971, WEEE, RoHS, and IEC 60601 standards.
· Knowledge of statistical techniques and reliability tools. Proficient with data analysis.
Formal training in Six Sigma methods combined with project deployment experience at the green belt or greater level is highly desirable.
POSITION RESPONSIBILITIES
· Lead cross-functional design teams in the preparation of Reliability Plans for activities such as Burn-in testing, Part Stress Analysis, HALT, HASS, and Environmental Stress Screening.
· Provide reliability predictions (e.g. MTBF) for systems, subsystems, and components.
· Participate in establishing and reviewing specifications/requirements for components, products and processes. Review changes to designs and processes and assess impact to assure reliability requirements are met.
· Prepare, review and approve verification and qualification test protocols and reports for assigned projects. Provide well-written reports and supporting documentation.
· Evaluate field performance of assigned products by analyzing field data. Investigate and evaluate product field problems and nonconforming product. Work with suppliers to resolve product performance issues or failures.
· Improve data collection tools, methods and processes for generating failure rates and other product performance data.
· Participate in activities to establish and maintain the Risk Management process, including application of ISO 14971. Contribute to hazard assessments and FMEAs.
· Prioritize and manage multiple priorities effectively with minimal direction.
· Provide solutions to a wide range of difficult challenges. Work independently to determine and develop solutions that are imaginative, thorough, practicable, and consistent with organizational objectives.
· Follow all Quality System Practices as defined by customer’s practices, policies and Standard Operating Procedures to ensure that FDA, ISO and European Medical Device quality standards and regulations are met where applicable.
YEARS OF EXPERIENCE
· 5+ years of previous experience in a quality position in a regulated environment with B.S./B.A.
· 3+ years of previous experience in a quality position in a regulated environment with M.S./M.A.
Thanks & Regards,
Girish
The power of focus
SancroSoft USA INC
4944 Sunrise Blvd, Suite B-4 || Fair Oaks, CA 95628
Phone : 916-671-5591|| Fax: 916-200-0305
E-Mail : girish@sancrosoftusa.com www.sancrosoftusa.com
Gtalk- saisancrosoft
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