R&D - Test Method Validation Engineer Job Listing at Kelly Services in Marlborough, MA (Job ID US3537492_BH9739923)

Description

R&D - Verification and Validation Engineer  

MUST HAVE: Minimum 6 years of experience designing, developing, and manufacturing plastic disposable kit products for regulated industry (medical device, class II and/or class III).

 

• Duration: 12+ months – estimated to end 2/2026 (contract extension expectation)
• Type: W2 contract (Third-party or C2C "Corp-to-Corp" arrangements WILL NOT be considered for this role)
• Pay: Negotiable depending on direct-related experience
• Work Authorization: Must be currently in the United States with active employment authorization documents. Visa sponsorship is not available, now or in the near future, for this position.
• Shift: 1st shift

 

Job Description Summary:

We are looking for a Verification and Validation R&D Engineer – Contingent Worker. This position is responsible for driving new product release which advances Cell Therapy.

 

What you will do:

• Lead and execute Verification and Validation (V&V) activities for disposable kit development.
• Define test plans, methodology, test equipment, and resources to support design Verification and Validation activities.
• Set-up design of experiments (DOE) and/or review plan and results to support product evaluation and process development.
• Establish acceptance criteria and sampling plans through statistical analysis or qualitative and quantitative testing.
• Perform and document technical root cause investigations in collaboration with R&D hardware, software, application, manufacturing, biology, and disposable kit system matter experts (SMEs).
• Support Risk Analysis activities within the R&D team and contribute to product Risk Management File (RMF).
• Advise R&D team members on execution of process validation (IQ/OQ/PQ) activities and metrology best practices.
• Mitigate project technical risks, resolve issues, deliver on-time, and establish strong communications with internal and external stakeholders.
• Assess product specifications and change control documentation for improving the manufacturing of new and existing devices.

 

Requirements:

• Bachelor's degree or equivalent in related engineering or scientific fields (mechanics, micro-mechanics, materials...).
• Long lasting experience (e.g. 6-10+ years) in designing, developing and manufacturing plastic disposable kit products for a regulated industry (e.g. medical device, class II and/or class III).
• Experience in verification activities related to disposable kits for medical device application associated to manufacturing processes such as injection molding, compression molding, tube extrusion, thermoforming, heat staking, ultrasonic welding, laser welding, snap-fitting, UV gluing, solvent bonding.
• Expertise in test method validation (e.g. DOE, OQ, Gage R&R, ), mechanical testing (e.g. pull/peel test, burst test, leak test, dye test, bubble test,...), in packaging design, transportation conditions simulation (e.g. ISTA) and stability study (e.g. pre-conditioning, aging test,...).
• Experience with test method validation (TMV), Gage R&R and process capability analysis.
• Familiar with disposable product manufacturing processes such as injection molding, compression molding, tube extrusion, thermoforming, heat staking, ultrasonic welding, laser welding, snap-fitting, UV gluing, solvent bonding and ISO class 7 & 8 cleanroom operations.

 

 

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)**

 

 

Work Authorization: Must be able to work in the United States with current employment authorization documents without VISA status that require Visa sponsorship now or in the future.

 

 

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 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 participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.

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