Sr. Development Engineer

Job Summary

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.

Principal Duties and Responsibilities

·        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:   

·        Expected Areas of Competence

·        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

Education:         ·      

B.S. degree from an ABET accredited

school (or global equivalent) in Biomedical, Mechanical, or Materials

engineering, or equivalent.

Fusion was founded to set a new standard in Health care consulting and staffing Industry. Our company is made up of Technical experts, dreamers, calculated risk-takers, diligent people that go to fight for the brand of our client. We offer Engineering and FDA remediation services for the Pharmaceutical, Bulk Drug Manufacturing, Biotechnology, Medical Device and Heath Diagnostic industries. Fusion was founded on the promise that we would provide a superior staffing experience for our clients by delivering the highest trained individuals.

Fusion provide innovative talent solutions that make our clients businesses better. Our verticals include Healthcare and FDA Remediation.

We exist to become the finest and most esteemed staffing company across USA, and we look forward to putting our talents to use to push your organization forward.