Note: The job is a remote job and is open to candidates in USA. LanceSoft, Inc. is seeking a Development Engineer to support post-market activities for existing Design History Files related to medical devices. The role involves managing documentation, risk analyses, design reviews, functional relationship analyses, tolerance stack-ups, verification and validation protocols, and updates to design and manufacturing elements.

Responsibilities

• Responsible for the post market activities of existing Design History Files for Medical Devices under the direction of a project leader or manager. Previous system experience with Vault is preferred. Excellent communication, teamwork, and organizational skills are essential. Candidates must be self-starters and self-motivators
• Author and Review existing Design History Files, identify scope, and mark gaps where necessary documents are missing
• Utilize Vault Systems to manage Document workflow
• Generate or analyze and update existing risk documentation (DFMEA or risk tables)
• Coordinate, prepare, and conduct design reviews with cross-functional teams
• Perform functional relationship analyses (FRA) and tolerance stack-ups
• Generate comprehensive protocols to test/analyze the product for design verification and design validation (V&V)
• Update prints and other design and manufacturing elements

Skills

• Excellent communication, teamwork, and organizational skills are essential
• Candidates must be self-starters and self-motivators
• Familiarity with Vault Systems
• Familiarity with drafting standards and geometric dimensioning and tolerancing (GD&T)
• Strong Background in DHF documentation authoring and executing for Medical Devices
• Ability to effectively work within a team to expedite completion of critical project tasks with cross functional groups including Regulatory and Quality
• Establishing a process method which meets performance and quality requirements
• Ability to give clear and concise oral presentations
• Technical writing
• Microsoft Office Suite
• B.S. degree from an ABET accredited school (or global equivalent) in Biomedical, Mechanical, or Materials engineering, or equivalent
• Previous system experience with Vault is preferred

Company Overview

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