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Senior Design and Quality Engineer - Westfield, United States - Instrument Technology
4 weeks ago
Description
The Senior Design and Quality Engineer will be responsible for various quality functions in support of product development for Medical Contract Manufacturing, tasks will include leading Risk Management activities, collaborating within Instrument Technology, Inc. (ITI) and to our customers throughout the product life cycle, mentoring team members, and ensuring compliance with the Quality Management System (QMS). As the Senior Design & Quality Engineer you will lead and maintain our ISO 13485 certification, through audits, training, and other applicable compliance tasks. You will hold yourself and the team accountable for developing best-in-class, safe, and effective medical devices that address customer and regulatory requirements. Instrument Technology, Inc. is a Veteran Owned Small Business, therefore being a small business, it is expected that this individual is self-motivated, ready to dig in to the day-to-day activities and can operate with minimal supervision and direction. As a team member of ITI, you will be expected to be part of a team that follows the four principles of Integrity, Intensity, Innovation, and Involvement to become the ideal partner for endoscopic and robotic surgery advancements.
DUTIES AND RESPONSIBILITIES:
Design and Process Development:
o Develop medical device protypes which conform to all aspects of the customers needs; lay out test plans and implements through reporting stages.
o Responsible for the transfer of the initial prototype phase through release to manufacturing (drawings, instructions, change orders, specifications, and inspection details); creativity in design efforts with ability to produce engineer drawings- proficient in SolidWorks.
o Knowledge and experience working in an ERP system; Visual Management and Visual Quality.
o Continuous support for existing legacy products.
o Identify opportunities for cost efficiency and manufacturing efficiency.
o Ability to identify and troubleshoot through experimental design logic.
o Knowledge of medical device design and development process including IQ/PQ/OQ.
o Experience with process development in assembly operations that include soldering, baking, pad printing, laser welding, bonding, and mechanical assembly.
Compliance Management: Responsible for adhering to Instrument Technology, Inc. standards practices while maintaining ISO 13485 QMS; this includes training and annual certification. Familiar with FDA regulations, and other relevant industry requirements.
Risk Management: Familiarity with risk analysis for product related designs and processes, DFMEA/PFMEA
Leadership: Provides guidance to the engineering team, fostering a team culture, accountability, and continuous improvement; works closely with the Director of New Product and Business Development to provide required information needed to generate quotes.
Communication: Able to effectively communicate through report writing, technical emails to both customers and vendors, as well as to team members within the organization.
Engineering Statistics: Has the knowledge and skills to analyze dataset concerning component dimensions, tolerances, type of material, and fabrication process control.
QUALIFICATIONS:
Bachelors degree in mechanical engineering.
5+ years of design and leadership experience.
KEY ATTRIBUTES:
Self-motivated and able to work under general direction with minimal supervision.
Ability to simultaneously manage multiple projects; organized and detail oriented.
Communicate in an efficient manner both internally and externally.
Strong analytical and problem-solving skills.
Able to work well in teams as well as independently.
Comfortable wearing multiple hats in a vertically integrated small business that has all the operational and employee challenges of the larger corporations but magnified within the footprint of a small business.
BENEFITS OFFERED:
Medical Insurance (Health, Vision, Dental).
401k with Employer matching.
Flexible Spending Account.
Employer paid life insurance.
Vacation and Sick time.
