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|Job Category :
||Mechanical Engineer – (2 openings; 100% onsite)
||San Jose, CA
|Job Description :
||We have 2 direct hire Mechanical Engineer positions open with a client of ours in medical device industry.Responsibilities:Lead product development of complex mechanical and electromechanical medical devices through various phases of concept feasibility, detailed design and verificationLead the creation of product requirements and design specifications, and determine applicable regulatory standards and ensures appropriate integration into product requirementsGenerate and maintain computer-aided drawings (CAD) using Solidworks, schematics and component specifications to document mechanical designsDrive hands-on fabrication and testing of prototypes using bench testing, animal and/or cadaver studies to evaluate product designs, and recommend and implement design modificationsPerform detailed design reviews and tolerance analyses to achieve product performance, cost, reliability and manufacturability requirementsServe as the main technical contact with customers and communicate directly with customers to understand project / product needs, and present technical updates, risks and issuesEffectively interface with and manage suppliers to fabricate prototype and final componentsDevelop test plans and protocols, and executes prototype testing and design verification testingLead and contribute towards creation of risk management documentation, including FMEAsCreate engineering-level manufacturing process instructions, bill of materials and related manufacturing documentationProactively anticipate technical risks and issues, and formulate and implement risk mitigations and corrective/preventive actionsAssist program managers in developing and maintaining project plans, and in tracking program health in terms of schedule, budget, and technical risks and issuesCollaborate with cross-functional team members to create and maintain Design History file per internal company procedures, FDA Design Control (21 CFR 820) and ISO 13485 requirementsMentor and provide guidance to other engineers and techniciansOther duties as assignedQualifications:BS in Mechanical / Biomedical Engineering with 5+ years of experience within the Medical Device industryExperience with product development of structural heart implants and catheter-based devices highly preferredStrong understanding of mechanical component manufacturing (i.e. injection molding, machining, sheet metal fabrication, etc.)Proven experience and proficiency using Solidworks for mechanical designStrong working knowledge and understanding of GD&T and mechanical design standardsExcellent communication skills, both written and oralJob Type: Full-timeBenefits:Dental insuranceHealth insurancePaid time offVision insuranceSchedule:8 hour shiftMonday to FridayEducation:Bachelor’s (Preferred)Experience:Medical Device design: 5 years (Preferred)SolidWorks: 5 years (Preferred)Work Location: One location
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