Mechanical Engineer
Mechanical Engineer # ABLJP00033471
6+ month contract position with a leading global health care company located in Alameda, California.
Major Responsibilities:
Specify, design, verify and validate new products, in accordance with applicable medical regulatory standards.
Responsible for the development of technical project plans and schedules covering all engineering activities, meeting all design control and product development SOP requirements.
Works in the development of significant design specifications, FMEAs, DOEs, verification and validation protocols.
Works in the creation of schedules and budgets
Communicates effectively and participates on cross-functional development teams.
Participates in technical design reviews of products and design requirements documents
Writing, submittal, and approval of Engineering Changes, as required. May review and approve ECs.
Act as independent reviewer on programs in which not directly involved.
Responsible for utilizing and maintaining the effectiveness of the quality system.
Ensures that products meet all applicable standards
Responsible for compliance with applicable Corporate and Divisional Policies.
Minimum Education Required:
Bachelors degree in Mechanical Engineering or equivalent engineering or scientific discipline. Master's degree ideal.
Minimum Experience/Training Required:
6+ yrs relevant experience and a BS degree. Some experience in engineering management or technical leadership desirable.
Good knowledge of general engineering principles.
Solid knowledge of regulations for medical device development, (ISO15197, ISO134851, ISO13485, FDA).
Strong technical experience in mechanical engineering discipline with excellent written and verbal communication skills is essential.
Extensive understanding of processes and materials used in the development and manufacturing of medical devices.
Experience in all of the following:
Performing complex engineering calculations and relating results to controlled tests, including statistical analysis, tolerance analysis
Working in a development environment with an emphasis on medical device product development.
Writing product requirements and design specifications.
Support equipment/facility/process commissioning and validation desired
Working on a development team with an emphasis on minimizing time to market.
Design for manufacture of low cost, high volume electronic products.
Solid understanding of GxP, ISO and medical device regulations, particularly with respect to the development of new products in a regulated environment.
Experience working in cross-functional team environments is required.
Accountability/Scope:
Development and execution of new medical devices, processes, equipment, materials, verification and validation
Implement approved Design Control procedures for development in accordance with FDA guidelines
Must be eligible to work in the United States
No Visa sponsorships available at this time
