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Process Validation Engineer (Medical Devices)

Kelly Services • Waltham, MA • 1h ago

Location : 100% ONSITE - Waltham, MA (02451)

Duration: 12 month contract - (extension potential)

Pay : Negotiable depending on DIRECT related experience Up to $45 - $50/hr

Type: W2 contract ONLY - (C2C OR THIRD-PARTY arrangements will NOT be considered)

Work Authorization: Must be currently located and authorized to work in the United States without sponsorship requirements.

Job Summary and Required Experience:

Strong understanding of medical device manufacturing process development, transfer, optimization, and validation (IQ/OQ/PQ).

Demonstrated experience supporting both internally developed and externally sourced manufacturing processes within regulated environments.

Solid foundation in statistical methods and data-driven problem solving, including DOE, process characterization, process capability analysis, and root cause investigation.

Proficient in use of Minitab, or similar statistical software.

Working knowledge of risk management and design control methodologies, including FMEA, control plans, and design transfer activities.

Experience with complex medical device manufacturing processes such as catheter assembly, balloon processing, laser processing, extrusion, thermal forming/heat setting, bonding, precision assembly, and/or injection molding preferred.

Familiarity with electro-mechanical and capital equipment manufacturing processes preferred.

Ability to troubleshoot complex manufacturing and process-related issues and implement effective corrective and preventive actions.

Ability to read, understand, and create engineering drawings using common engineering software, including GD&T interpretation for tight-tolerance components.

Ability to conduct complex statistical, geometric, and mathematical calculations.

Demonstrated project and task management skills across multiple concurrent initiatives.

Strong technical communication skills, including the ability to write and review protocols, reports, specifications, and technical documentation.

Kelly does not expense relocation/interview costs. *

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

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 is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly 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.

Kelly may use AI-powered tools during the recruitment and hiring process. For full details, including how Kelly uses AI, your rights, and how to request a reasonable accommodation, visit the Recruitment Artificial Intelligence Notice (https://www.kellyservices.com/hubfs/myKelly/Resources/Employment_Policies/Recruitment-Artificial-Intelligence-Notice.pdf?hsLang=en) .

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.

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