Manufacturing Engineer

Every day, Kelly Services connects professionals with opportunities to advance their careers. We currently have an exciting contract opportunity with one of our leading clients!

Title : Manufacturing Engineer

Location : West Valley City, UT

Duration : 12 months +

Overview

• Will be working an EUMDR Special Project
• The position will need to help execute gap assessments against EUMDR.
• The individual should have a strong validations background. After the gap assessment, the validations will take place.

Responsibilities

• Generation and execution of validation plans, validation protocols (IQ / OQ / PQ), and completion reports, with a major focus on Test Method Validation and EUMDR Validation Remediation of medical devices.
• Provide statistical analysis of the date to support the reports.
• Troubleshooting equipment / processes that do not perform as intended during validation runs.
• Recommend process / quality improvements as part of validation runs.
• Evaluate, investigate and document non-conformances incidents and / or protocol deviations.
• Complete assigned Non-Conformance and CAPA investigations and prepare investigation reports.
• Develops and maintains an effective cross-functional working relationship with plant and corporate Manufacturing, Engineering, Regulatory, and Quality Assurance personnel.
• Work on project teams with other internal departments, external vendors, and customers as required.
• Assure that existing processes and assigned activities fully comply with regulatory and / or international agencies, such as FDA, ISO, OSHA, EPA, among others.
• Participate in the compilation and review of technical documentation for both domestic and international regulatory submissions.
• Participate in external audits such as : FDA, Notified Body (BSI) and Corporate, among others.
• Performs other related duties as necessary.

Required Qualifications

• BS in Engineering, preferably Mechanical, Manufacturing, Industrial, Electrical, Chemical, or Biomedical (Professional Engineer License) or sciences related field.
• Minimum of 4-6 years of experience in the medical device and / or pharmaceutical manufacturing environment.
• Experience in validations such as : manufacturing equipment, manufacturing processes, Test Method validation, stability or aging
• Knowledge of FDA, OSHA, EPA, and GMP's and ISO requirements.
• Knowledge in Organizational Excellence and Lean / Six Sigma.
• Strong Project Management skills
• Able to develop technical documentation such as : Change Controls, Validation Plans, Validation Protocols, Technical / investigation reports, SOP, and others.
• Lean / Six Sigma Green or Black Belt Certification is a plus.

Competencies Required

• Excellent communication skills and a strong track record of working cross-functionally.
• Demonstrated ability to think strategically.
• Ability to lead teams through complex projects and provide departmental technical leadership.

Additional Information

• Monday Friday
• Flexible Work Model : will be required onsite in the beginning and for executions. Opportunity to work remote a few days a week
• Interview process : onsite interview and site tour.

Important information : This position is recruited for by a remote Kelly office, not your local Kelly branch. Applicants must be legally permitted to work in the United States.

Please contact Taryn Carbone ( taryn.carbone@kellyengineering.com ) for immediate consideration.

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.