Job Description

Manage the Design Control and product design and change Risk Management processes for sterile catheter-, software-, electromechanical-based medical device product families.   Provide Quality Engineering support for Product Development Projects throughout all phases of Design Controls (Concept to Launch) and Design Risk Management.

This is a key contributor position working closely with R&D, Operations, Commercial, Regulatory and Operations Quality to ensure compliance with AVI’s QMS and FDA QMSR requirements, with particular focus on Design Controls and Risk Management.

Duties &

Responsibilities

· Responsible for overall Design Quality process to ensure that company design control projects comply with internal design control and risk management procedures in accordance with FDA, ISO and other applicable requirements

· Lead cross functional teams to implement and periodically review hazard analyses, risk evaluation, assessment and other risk management processes

· Provide guidance to project team members to ensure that design control requirements are being met in an effective manner in order to achieve quality by design

· Support development, implementation and maintenance of Design Verification & Validation methodologies and best practices to impact product quality and launch timeliness

· Collaborate with Operations and Operations Quality to ensure effective and successful design transfer to manufacturing

· Drive quality focused design and development of device software by defining the requirements, design, verification and validation plan and strategies while maintaining traceability and compliance to IEC 62304 and FDA guidance documents related to medical device software

· Participate in product cybersecurity activities including product security planning, threat analysis, cybersecurity risk assessments, periodic monitoring and reporting

· Act as a subject matter expert for Quality Engineering practices, such as statistical analysis, failure investigations, hazard identification and risk analysis, and quality data trending and analysis

· Assist in Post-Market Surveillance (PMS) initiatives, including failure investigation, record review, and data trending

Qualifications

· BS in Mechanical, Electrical, or Biomedical Engineering or other scientific or related discipline

· 5-8 years of design assurance experience in medical device design and manufacturing environment

· Proven track record of completing new product introduction transfers to Operations

· Working knowledge of Medical Device Regulation FDA 21 CFR 820 and ISO 14971, 13485, ISO 10993, IEC 60601 and IEC 62304 series of standards, other applicable regulations and industry standards pertaining to the design of medical devices

· Experience with preparing and reviewing design documentation in support of regulatory submissions

· Working knowledge of data analysis methods, including basic statistics, preferably using Minitab or other similar data analysis software

· Working knowledge with various quality tools such as Failure Mode and Effects Analysis (FMEA) and Use Related Risk Analysis (URRA), Statistical Process Control (SPC), Root Cause Analysis (RCA), Measurement Systems Analysis (MSA) & Gage Repeatability and Reproducibility (Gage R&R)

· Experience with manufacturing complex medical devices, including process validation and equipment qualification requirements (IQ/OQ/PQ). 

· Experience managing third-party development and test organizations.

· Ability to communicate ideas and information clearly, effectively, and concisely

· Possess the following key traits: teamwork, flexibility and adaptability to change, critical reasoning and excellent data presentation skills, excellent written and verbal communication and skills

The ideal candidate must have a foundation in being a self-starter with strong organization skills.