Project Engineer

Kelly Services; Añasco (PR); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Telemedicine

Term life insurance

Whole life insurance

Accident insurance

Critical illness insurance

Legal plan

Short-term disability

Retirement savings plan

Service bonus

Holiday pay (up to eight paid holidays

Transit spending account

Paid sick leave

Job summary

Kelly Services is seeking a Contractor Project Engineer to lead labeling update initiatives within a regulated medical device environment. You will partner with Project Engineering, Quality, Regulatory Affairs, and Operations to drive changes from initiation through validation and closure.

The role requires strong project management, technical writing, and communication skills, with readiness to support multiple shifts and weekends as needed. English proficiency is essential.

Qualifications

• Bachelor’s degree in engineering field.
• Minimum 5 years in validation, labeling, quality, manufacturing, or regulated environments.
• Experience leading labeling update projects.
• Experience with change control processes and project lifecycle management.
• Experience validating labeling equipment (printers, barcode systems, vision systems, labeling software).
• Working knowledge of FDA QSR, ISO 13485, ISO 9001, GMP or equivalent regulated environments.
• Experience creating and executing validation protocols and reports.
• Experience using Microsoft Project for planning and tracking.
• Experience with PLM systems (e.g., Agile PLM) and ERP platforms (Oracle).
• Strong analytical, problem-solving, risk assessment, organizational, and technical writing skills.
• Strong verbal and written communication skills and ability to work effectively within cross-functional teams.
• Proficiency in MS Office applications including Excel, Word, PowerPoint, and Project.
• Ability to work in ISO Class 7 and Class 8 cleanroom environments with gowning.
• Ability to support multiple shifts and weekends.
• Demonstrated initiative, accountability, adaptability, and continuous learning.

Responsibilities

• Lead and execute labeling update projects from initiation through implementation and closure.
• Manage labeling-related change controls and assess risks and compliance impacts.
• Validate labeling equipment and systems as required.
• Coordinate project activities with cross-functional teams (Engineering, Quality, Regulatory).
• Maintain documentation and prepare validation protocols and reports.

Skills

Project management

Technical writing

Problem solving

Cross-functional collaboration

Analytical thinking

Education

Bachelor’s degree in Industrial/Mechanical/Biomedical Engineering

Tools

Microsoft Project

Excel

Word

PowerPoint

PLM systems (e.g., Agile PLM)

ERP systems (Oracle)

Job description

Position Summary

We are seeking a Contractor Project Engineer to lead and execute labeling update projects supporting the Project Engineering Department within a regulated medical device manufacturing environment. This role partners closely with Project Engineering, Quality, Regulatory Affairs, Operations, and other cross-functional teams to implement labeling changes, coordinate project activities, execute validation efforts, and ensure compliance with quality and regulatory requirements.

The specialist will be responsible for managing labeling-related change controls, assessing risks and compliance impacts, validating labeling equipment and systems as required, and driving projects from initiation through implementation and closure. The ideal candidate is a hands-on professional with strong project management, technical writing, problem-solving, and communication skills, along with a continuous improvement mindset.

Candidates must be proficient in English (written and verbal) and be available to support multiple shifts and weekend activities as business needs require.

Required Qualifications

• Bachelor’s degree in Industrial Engineering, Mechanical Engineering, Biomedical Engineering, or a related technical discipline.

• Minimum of 5 years of experience in validation, labeling, quality, manufacturing, or other regulated industry environments.

• Demonstrated experience leading and executing labeling update projects.

• Experience with change control processes and project lifecycle management.

• Experience validating labeling equipment, including printers, barcode systems, vision systems, and labeling software.

• Working knowledge of FDA Quality System Regulations (QSR), ISO 13485, ISO 9001, GMP requirements, or equivalent regulated environments.

• Experience creating and executing validation protocols and reports.

• Experience using Microsoft Project for planning, scheduling, tracking, and executing projects.

• Experience with Product Lifecycle Management (PLM) systems such as Agile PLM and ERP platforms such as Oracle or equivalent systems.

• Strong analytical, problem-solving, risk assessment, organizational, and technical writing skills.

• Strong verbal and written communication skills and ability to work effectively within cross-functional teams.

• Proficiency in Microsoft Office applications, including Excel, Word, PowerPoint, and Project.

• Ability to work in ISO Class 7 and Class 8 cleanroom environments while wearing required gowning for extended periods.

• Ability to support multiple shifts and weekends, as required by project and operational needs.

• Demonstrated initiative, accountability, adaptability, and commitment to continuous learning.

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Please note: The following benefits reflect Kelly's general offerings. Eligibility may vary by assignment, location, and job type. 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.