Accessvascular

Senior Designs Assurance Quality Engineer

Billerica, MA · Senior

Sponsorship not specified$135k-$160kDetected 154 days ago

Data AnalysisStatisticsFDA RegulatoryMedical DevicesCommunicationAdaptability

About the role

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.

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

Proven track record of completing new product introduction transfers to Operations
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
Experience managing third-party development and test organizations.
Ability to communicate ideas and information clearly, effectively, and concisely
The ideal candidate must have a foundation in being a self-starter with strong organization skills.

Commensurate With Experience
Access Vascular was founded in 2015 to address the most common and costly complications of intravenous therapy: infection, thrombosis and phlebitis.
The company is developing a suite of venous access devices made from patented biomaterials which are highly biocompatible and have demonstrated 6X fewer complications..
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.
$135,000 - $160,000 USD

5-8 years of design assurance experience in medical device design and manufacturing environment
Manage the Design Control and product design and change Risk Management processes for sterile catheter-, software-, electromechanical-based medical device product families.
Experience with manufacturing complex medical devices, including process validation and equipment qualification requirements (IQ/OQ/PQ).

This listing is sourced directly from Accessvascular's careers page and normalized into a canonical job model.