Sr. Design and Quality Engineer

Growing company in Westfield is seeking a Sr. Design/Quality Engineer. The proper candidate will eventually lead and maintain the ISO 13485 certification (not immediately). The company offers career growth potential as well as a competitive salary and a comprehensive benefits package. Don't miss this exciting opportunity. Apply today, we'd love to meet you!

Sr. Design/Quality Engineer

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 the organization 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. Our company is a veteran owned, small business, therefore, 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, 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.

Responsibilities:

Design and Process Development:

• Develop medical device protypes which conform to all aspects of the customer's needs; lay out test plans and implements through reporting stages.
• 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.
• Knowledge and experience working in an ERP system; Visual Management and Visual Quality.
• Continuous support for existing legacy products.
• Identify opportunities for cost efficiency and manufacturing efficiency.
• Ability to identify and troubleshoot through experimental design logic.
• Knowledge of medical device design and development process including IQ/PQ/OQ.
• 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.

Education/Experience

• Bachelor's degree in mechanical engineering.
• 5 years of design and leadership experience.

After you have applied, download our Staffmark Group WorkNOW App to receive real-time job offers and apply for additional opportunities. You can download it from the App Store or get it on Google Play.

With company roots going back over 30 years, Advantage Technical is an engineering and information technology services company and a national leader in the provision of technical resources today. These services include Staff Augmentation, Direct Placement, Project Resourcing and Outsourcing - delivered from 40 key market locations, by over 3500 specialized contractors, to over 500 clients across North America. Advantage Technical is a Best of Staffing Diamond Award winner for both Clients and Talent. For more information about the industries and services offered by Advantage Technical, please visit AdvantageTechnical.com.

Advantage Technical is committed to providing equal employment opportunity for all persons regardless of race, color, religion (including religious dress and grooming practices), sex, sexual orientation, gender, gender identity, gender expression, age, marital status, national origin, ancestry, citizenship status, pregnancy, medical condition, genetic information, mental and physical disability, political affiliation, union membership, status as a parent, military or veteran status or other non-merit based factors. We will provide reasonable accommodations throughout the application, interviewing and employment process. If you require a reasonable accommodation, contact us. Advantage Technical is an E-Verify employer. This policy is applicable to all phases of the employment relationship, including hiring, transfers, promotions, training, terminations, working conditions, compensation, benefits, and other terms and conditions of employment.

All employees are directed to familiarize themselves with this policy and to act in accordance with it. All decisions with respect to employment matters and other phases of employer-temporary employee relationships will be in keeping with this policy and in accordance with all applicable laws and regulations.