Senior Designs Assurance Quality Engineer

Billerica, MA - USA

Monthly Salary: Not Disclosed

Posted on: 2 days ago

Vacancies: 1 Vacancy

Job Summary

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 AVIs 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 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.

Compensation Commensurate With Experience

$135000$155000 USD

About Access Vascular

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. .

Required Experience:

Senior IC

Job DescriptionManage 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 (Con...