NHS Human Services, Inc.

R&D - Test Method Validation Engineer

MUST HAVE: Minimum 5 years of experience designing, developing, and manufacturing plastic disposable kit products for regulated industry (medical device, class II and/or class III).

• Location : (ONSITE) - Marlborough, Massachusetts (01752)

• Duration : 4+ months - Desired Start Date: 8/1/2024 - End Date:12/31/2024 (Contract extension expectation)

• Type : W2 contract (NO C2C OR THIRD PARTY)

• Shift: 1st shift

• Pay: Negotiable depending on related direct experience

Summary:

The R&D - Verification and Validation Engineer is responsible for working with our expert Cell and Gene Therapy Disposables R&D team of more than 30 employees across the world who have a passion for developing products which will influence the future of medical technologies.

What you’ll do

• Write test protocol, setup design of experiments, execute tests, analyze results and document report for design verification and validation activities with focus on quality, compliance and execution rigor.

• Derive test requirements from the specifications, define test plan and methodology, estimate effort and resources plan to cover design verification and validation campaign.

• Establish acceptance criteria, sampling size, assess through modelling or qualitative/quantitative testing, evaluate the performance according to URS, SRS (design inputs and outputs).

• Develop good practice guidelines for performing disposables kit verification and validation activities and organize standardization and harmonization within the R&D disposables team.

• Mitigate project technical risks, resolve issues, deliver on-time and communicate effectively.

Who you are

• Master’s degree or equivalent in related engineering fields (mechanical, materials...).

• Minimum 5 year-experience in designing, developing and manufacturing plastic disposable kit products for regulated industry (medical device, class II and/or class III).

• Well-founded knowledge and practical experience of relevant regulations (ISO13485, FDA 21 CFR Part 820), specifically for the US and European market product submission.

• Demonstrated experience in defining and managing verification and validation plan, execution, statistical data analysis and report.

• Experience in verification activities related to disposable kits for medical device application associated to manufacturing processes as injection molding, compression molding, tube extrusion, thermoforming, heat staking, ultrasonic welding, laser welding, snap-fitting, UV gluing, solvent bonding.

• Strong organizational and communication skills in multisite, multidisciplinary, multicultural matrix organization.

Work Authorization:

• Must be able to work in the United States with current employment authorization documents.

Important information: To be immediately considered, please send an updated version of your resume to Deas172@kellyservices.com

* (Kelly does not expense relocation/interview costs)

In addition to working with the world’s most recognized and trusted name in staffing, Kelly employees can expect:

• Competitive pay

• Paid holidays

• Year-end bonus program

• Recognition and incentive programs

• Access to continuing education via the Kelly Learning Center

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here (https://www.mykelly.com/help-support-working-with-kelly-us/#Benefits) for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

Why Kelly ® Engineering?

Your engineering skills are in demand, but how do you find the right fit? Easy. At Kelly Engineering, our team creates expert talent solutions to solve the world’s most critical challenges. We connect you with leading organizations where you can collaborate on innovative projects, work with cutting-edge technologies and accelerate your growth. Whether you prefer the variety and flexibility of short-term projects or are looking for a long-term opportunity, we’re here to guide you to the next step in your engineering career.

About Kelly

Work changes everything. And at Kelly, we’re obsessed with where it can take you. To us, it’s about more than simply accepting your next job opportunity. It’s the fuel that powers every next step of your life. It’s the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.

Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly’s Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.

Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly’s Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.