Product Design Engineer who will be responsible for the design and prototype build of Medical and Spa products.
[*] The successful candidate will be responsible for:
Lead major projects or phases of projects to resolve advance and complex technical problems.
Design controls to ensure compliance with good manufacturing practices (FDA QSR and EN 13485 regulatory requirements).
Experience with ISO 13485 and / or related medical device standards
Author and execute product and system specifications, validation and test protocols and validation and test reports.
Lead risk management activities including, fault tree analysis and failure mode and effects analysis activities to ensure design, use and process shortcoming are identified and appropriately addressed.
Improve present product designs to improve quality
Implement design requests which produce a robustly engineered product by considering industry standards, sound engineering principles and the cost factors of design and manufacturing methods
Follow Design Control Process requirements including design verification and validation, and design history file updates (DHF)
Demonstrated Experience in the following areas will position you as the ideal candidate:
Technical / Experience:
Material Exp. Wood, Metal, Plastic
Mechanical Design Exp. & Modeling Capability for Stress & Failure Points
CNC Machine Programming
Knowledge & Exp. In Regulations & Mechanical & Electrical Stds:
Risk Assessment Solution/ Design Alternatives
ETL Requirements / Risk / Mitigation
Hands on Prototype – make it Manufacturable
Speed & Efficiency on Engineering Drawings
Technology / Understanding of Market Place Solutions:
Assess & Communicate Present Company Technology & Capability
Project Engineering Roadmap Capabilities – Planning & Communication
Leadership / Attitude:
Driver of Innovation
[*] Qualified Candidates must be able to demonstrate the following:
Bachelors Degree in Mechanical Engineering, 5+ years’ work experience or equivalent experience in related industry.
Proficient in parametric 3D CAD design / 3D Modeling.
Proficiency with Microsoft Office
Ability to work independently and in team environment.
Ability to effectively communicate written and verbally.
Analytical skills and problem solving capacities. Motivated to drive to improve performance.