Contribute to resolving significant technical issues and to the development of company objectives. Works independently or in a lead role on the design and development of products (FreeStyle Libre and next-generation products). Works independently on identifying and developing new technologies for implementation into new products. Exercises independent judgment in identifying, recommending and implementing significant and/or complex new design improvements to meet new product development and regulatory requirements. May lead technical teams in the accomplishment of mechanical engineering activities. Develops networks involving cross functional/cross departmental groups as well as communication to senior management.
1.Specify, design, verify and validate new products, in accordance with applicable medical regulatory standards. 2.Responsible for the development of technical project plans and schedules covering all engineering activities, meeting all design control and product development SOP requirements. 3.Works in the development of significant design specifications, FMEAs, DOEs, verification and validation protocols. 4.Works in the creation of schedules and budgets 5.Communicates effectively and participates on crossfunctional development teams. 6.Participates in technical design reviews of products and design requirements documents 7.Writing, submittal, and approval of Engineering Changes, as required. May review and approve ECs. 8.Act as independent reviewer on programs in which not directly involved. 9.Responsible for utilizing and maintaining the effectiveness of the quality system. 10.Ensures that products meet all applicable standards 11.Responsible for compliance with applicable Corporate and Divisional Policies.
8 yrs relevant experience and a BS degree or 6 yrs relevant experience and a MSdegreepreferred. 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:
oPerforming complex engineering calculations and relating results to controlled tests, including statistical analysis, tolerance analysis
oWorking in a development environment with an emphasis on medical device product development.
oWriting product requirements and design specifications.
oSupport equipment/facility/process commissioning and validation desired oWorking on a development team with an emphasis on minimizing time to market.
oDesign 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.