What are the responsibilities and job description for the Senior Design Assurance Engineer position at GTT, LLC?

Job Description

Job Title : Senior Design Assurance Engineer

Contract Duration : 3 Months

Pay range : $45 - 70 / hr

Location : Marlborough, MA

Work Type : Onsite

Job Summary :

Senior Design Assurance Engineer provides design assurance support for new product development and on-market medical devices.
This role will be responsible for facilitating the application of design controls while supporting product development, manufacturing-related design changes, maintaining regulatory compliance, implementing improvements for manufacturability, and evaluating cost reduction efforts.

Essential Duties :

Duties are listed in order of greatest importance. Senior Design Assurance Engineer may be asked to perform other function-related activities in addition to the below-mentioned responsibilities as reasonably required by business needs.

Participate independently on new product development projects, assuring product inputs are clearly defined and assuring design verification and validation activities are appropriate and compliant to confirm input requirements are met. Test method validation would be an element of assuring verification / validation is acceptable.

Participate independently in sustaining product projects, assuring the project is clearly defined and stays on task, confirming product inputs are continuing to be met, and necessary verification, validation, and risk management activities are completed.

Work collaboratively with R&D to coordinate design elements of Risk Management files for products to assure compliance with applicable standards and internal policies.

Responsible for independently coordinating the Health Risk Assessment team when needed for evaluation of on-market products, must demonstrate efficient and effective analysis of the situation, including problem definition and impact.

Assess change requests of products for impact to design and determine supporting information required for implementation of changes.

Required Education :

Technical Bachelor Degree

Required Experience :

2-5 years experience preferably in the medical device industry

Required Skills :

Experienced with FDA Quality System Regulations, especially Design Control requirements, ISO 13485, and Medical Device Directive

Experienced with ISO 14970, Risk Management

Familiarity with Usability, Reliability, Electrical Safety, Software, Sterilization, Packaging, and Biocompatibility standards and requirements.

Working knowledge of verification and validation requirements for a regulated product

Working knowledge of requirements analysis, including development of testable and measurable specifications

Ability to effectively work on project teams, including taking leadership roles on critical tasks to assure appropriate and timely completion / resolution

Ability to appropriately assess written product and project documentation as the principle advocate for compliance, and ability to effectively communicate assessment

Preferred Skills :

Working knowledge of test method validation, root cause failure analysis, statistical methods, and design of experiment

Physical Demands :

A thorough completion of this section is needed for compliance with legal standards such as the Americans with Disabilities Act. The physical requirements described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions

Sit; use hands to finger, handle, or feel objects, tools, or controls.

Stand; walk; reach with hands and arms; and stoop, kneel, crouch, or crawl.

Note :

Organizational Relationships : Works with Divisional personnel and Costa Rica personnel including R&D, Regulatory, Marketing, PMQA, Manufacturing Engineering, and Quality Engineering

25-16228 : #LI-GTT #gttjobs #LI-Onsite

Company Description

We are a Native American-owned, economically disadvantaged corporation that highly values diverse and inclusive workplaces. Our clients and partners are among the most successful and innovative organizations in the world. Our top clients are Fortune 500 banking, insurance, and financial services firms, some of the nation’s largest life sciences, biotech, utility, and retail companies, and prestigious educational institutions in the Ivy League tier.

There is always a new opportunity for success when you look through all of the open job opportunities on our website’s career page. Just click on this link : https : / / bit.ly / gttcareers

Awards

SIA’s Fastest Growing Staffing Firm : 2023 and 2015

SIA’s Best Staffing Firm to Work for : 2019 -2023

Inc 5000 Fastest Growing Private Company : 2023, 2022, 2016, 2015

Randstad Preferred Supplier : 2020 - 2023

TechServe Alliance Excellence Award. 2019

NH Business Magazines Fast 5 fastest growing companies

Ernst & Young Entrepreneur of the Year Finalist : 2015

Company Description

Global Technical Talent is a subsidiary of Chenega Corporation (www.Chenega.com) with over 1.3 billion US$ in revenue and 5800 US employees. We provide Total Talent Solutions, Global staffing, SOW, RPO, Direct Sourcing, and Global Payroll with physical offices in US, Canada, and India. GTT Digital headquartered in Toronto specializes in providing high-tech digital and banking talent to some of the nation’s largest financial institutions. As a leader in the staffing industry for over 22 years, we have become one of the largest staffing firms in the New England region, working with Fortune 500 clients and cutting-edge, technology-driven recruiting infrastructure. We are a Native American-owned, economically disadvantaged corporation that highly values diverse and inclusive workplaces. Our clients and partners are among the most successful and innovative organizations in the world. Our top clients are Fortune 500 banking, insurance, and financial services firms, some of the nation’s largest life sciences, biotech, utility, and retail companies, and prestigious educational institutions in the Ivy League tier. There is always a new opportunity for success when you look through all of the open job opportunities on our website’s career page. Just click on this link : https : / / bit.ly / gttcareers Awards SIA’s Fastest Growing Staffing Firm : 2023 and 2015 SIA’s Best Staffing Firm to Work for : 2019 -2023 Inc 5000 Fastest Growing Private Company : 2023, 2022, 2016, 2015 Randstad Preferred Supplier : 2020 - 2023 TechServe Alliance Excellence Award. 2019 NH Business Magazines Fast 5 fastest growing companies Ernst & Young Entrepreneur of the Year Finalist : 2015

Salary : $45 - $70

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