*Direct Vendor: TCS America *
*The following requirement is open with our client.* *Title : **Principal/Staff/Senior Engineer* *Location : **WARSAW, IN* *Duration :**1 year* *Rate : **Open* *Visa Status : Any work status * *In-person Interview : No* *Assignment Start Date : ASAP* *Yrs of Experience :*8+ Years *Technical/Functional Skills:* - Perform verification & validation activities for medical devices - Create & manage Risk Management activities & documentation through company quality systems - Exposure to & awareness of regulatory requirements in key geographies- US & EU - Experience in conducting DFMEA's in Medical, Aerospace, Oil & Gas or Pharmaceutical industry - Acts as a Lead Design Engineer for own, and others design commitments; delivering to agreed timescales in line with project plans. - Leading other project team members, proactively manage design related engineering changes, to ensure they are implemented in a timely manner *Roles & Responsibilities: * - interact with all levels of company management, external experts and vendors - Orchestrate and participate in Design FMEA’s - Ensure that engineering designs are safe, effective and appropriately verified. Scope includes externally generated designs, 3-D models and drawings; ensuring that data conforms to company standards and worldwide Regulatory requirements - Assume responsibility for own commitments & delivering to agreed timescales per project deadlines - Provide updates to company management regarding work performed & deliverables - Verify own work through company’s systems - Create and manage Engineering Change Orders if required - Make use of the offshore team, based in various locations, with prior approval of the concerned line manager(s) - Escalate/raise concerns to the concerned line manager(s) - To collate relevant performance metrics and present to concerned line manager(s). The exact nature of these metrics will be decided and agreed upon once the project starts - Develop verification and validation strategies for end-to end process validation - Plan, conduct & direct engineering assignments to completion. Ability to function within a matrix organization and drive collaboration to execute project actions in ambiguous situations, with a sense of urgency - Ability to identify and translate work content into resourcing needs - Transposes own knowledge of manufacturing methods and limitations into cost effective design solutions *Experience Required:* - Experience in the areas of new product development, Design for Manufacturing & Assembly (DFM & A) and risk management (e.g. FMEAs) - Successfully working across geographical and organizational boundaries - Experience within a medical device production environment or other health care regulated environment preferred - Knowledge of FDA/ISO requirements associated with the development of medical devices, including Design Control is preferred *Generic Managerial Skills:* - Highly developed negotiation and influencing skills - Highly developed and proven written and oral communication skills - Organizational / planning skills - Strong analytical skills - Comfortable with using and facilitating a variety of problem solving methodologies - Mentors and develops junior staff within the TCS delivery organization - Willing to work with offshore teams in remote locations *Please provide me following details: **Please give us particular time for interview slots.* *CONSULTANT’S PARTICULARS* Full Name of the Candidate (First, Middle, Last) Gender (Female/Male) Date of Birth (MMM-DD-YYYY) Contact Number (123-456-7890) Email ID Skype ID Best time to reach for a Tech-screen today (1) Best time to reach for a Tech-screen Next business day (2) Best time to reach for a Tech-screen Next business day (3) Availability (Immediate/x weeks/Specific date) Undergrad Education (Bachelor’s Degree) Major in: University: Attended from: (mm/yy) To: (mm/yy) Work Experience (specify a number) Relevant: years Total: years Current Location (City, State) Willing to Relocate (yes/no) Visa Status (USC, GC, H1B, OPT, L2, GC-EAD) Hourly rate (Terms: 1099 or C2C) $ on 1099/C2C Employer’s Particulars (if applicable): Company Name Contact person’s name (Recruiter) Email ID Contact Number(s) Thanks & Regards, Ramya Ascii Group, LLC Phone: 248-247-8644 Email:ra...@asciigroup.com -- You received this message because you are subscribed to the Google Groups "oraapps" group. To unsubscribe from this group and stop receiving emails from it, send an email to oraapps+unsubscr...@googlegroups.com. To post to this group, send email to oraapps@googlegroups.com. Visit this group at http://groups.google.com/group/oraapps. For more options, visit https://groups.google.com/groups/opt_out.
