In this exciting role you will:
• Mentor less senior Quality Engineers and quality technicians.
• Provide guidance to Engineering staff and other personnel and ensures that Design Control requirements are being met in an effective manner, including Design Requirements, Design Verification/Validation, Risk Management, Test Method Validation, Component Engineering, and Process Validation.
• Lead the investigation of complex technical issues.
• Hands on participant in early stages of product development including but not limited to physician interaction, competitive product testing, and prototype testing.
• Identifies and manages risk throughout the development process with the use of FMECA and/or other risk management tools.
• Review and approval of protocols and reports to ensure that the testing is technically sound and sufficient to meet internal/external requirements and overall project quality objectives.
• Review and approval of design and manufacturing documentation including material specifications, drawings, inspection procedures, and manufacturing procedures, to ensure that the resulting products and processes are capable of producing products that are safe and effective and in full compliance to company policies and procedures.
Must Have: Minimum Requirements
• Bachelor’s Degree or higher in Science or Engineering (or related field)
• 7+ years engineering experience in medical device or in other regulated industries with a Bachelor’s degree
• 5+ years of engineering experience in medical device or in other regulated industries with a Master’s degree
It would be ideal if you also had the following experience:
• Experience in related engineering areas, e.g. R&D or Manufacturing may also be applicable if experience includes work responsibilities listed above
• Prior experience in the Medical Device industry in design and development of Medical Devices.
• Experience with vascular devices, embolic coils, stents, catheters, balloons, and aspiration devices
• Self-motivated and committed to a team approach
• Ability to conduct hands-on technical work
• ‘Can Do’ attitude with continuous improvement mindset
• Strong interpersonal, organizational and project management skills
• Strong oral, presentation and technical writing skills
• Demonstrated proficiency in decision making – preferably across a broad spectrum of Quality Engineering responsibilities
• Extensive knowledge and application of quality tools:
• Risk Analysis