Job Summary:
Under the supervision of the Manufacturing Engineering Manager, the Manufacturing Engineer is responsible for supporting manufacturing by managing & executing assigned projects. This individual will serve as the technical lead on projects and will plan, schedule, organize, and drive completion of project activities. The Manufacturing Engineer is responsible for supporting manufacturing by developing, qualifying, implementing and maintaining manufacturing equipment, processes and procedures.
Job Responsibilities : (Primary Duties, Roles, and/or Authorities)
Assist CTW (cost saving efforts)/continuous improvement initiatives.
Generate actionable cost savings/continuous improvement ideas.
Serve as the technical lead for projects.
Lead technical project execution.
Develop assembly and test procedures. Create written instructions. Review with document users & update as necessary based on review comments.
Develop and maintain specifications and procedures for manufacturing, test and inspection processes.
Develop, create and qualify manufacturing and test equipment.
Coordinate with divisional and plant functional groups to evaluate and implement changes to products & processes.
Communicate status of changes to functional groups as well as plant management.
Evaluate projects
Develop and maintain specifications and procedures for manufacturing, test and inspection processes.
Responsible for designing and developing processes to optimize process flow, reduce variability, improve operating capabilities, and ensure operator safety.
Responsible for creation/update of PFMEA/Risk analysis.
Identify need for validation of manufacturing equipment/process and support systems to meet product requirements, regulations, quality and company policies.
Lead the validation/qualification effort for equipment and processes (IQ, OQ & PQ).
Maintain working knowledge of company policies and procedures, ISO and FDA requirements.
This job description is not a comprehensive listing of activities, duties or responsibilities that are required of the employee for their job. Duties, responsibilities, and activities may change at any time with or without notice to support the business.
Education and Experience:
Bachelor's degree in an engineering discipline.
Preferred: Experience in a manufacturing environment in a regulated industry, medical device.
Knowledge and Skills:
Experience with troubleshooting electromechanical systems.
Excellent communication (verbal & written) and interpersonal skills
Ability to read and understand mechanical drawings and electrical schematics.
Detail oriented with high level of problem solving and analytical skills
Familiarity with project management methodologies. Experience with leading technical projects preferred.
Experience working closely with design engineering, quality engineering and production personnel.
Familiarity with FDA regulatory requirements, GMP, ISO, lean, process validation and six sigma methodologies.
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 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.
