Job Title: Manufacturing Engineer
Location: Brooksville, FL (Relocation assistance available)
Job Type: Direct Hire
Salary: $120,000 - $150,000
Work Authorization: Must be able to work in the U.S. without sponsorship
Position Overview
We are seeking a proactive and detail-oriented Manufacturing Engineer to serve as a key link between Engineering and Production within our ISO 13485-compliant medical device manufacturing environment. This role is responsible for developing, validating, and sustaining robust manufacturing processes, as well as maintaining accurate documentation and leveraging quality systems to ensure product reliability, regulatory compliance, and operational efficiency.
Key Responsibilities
Process Development & Documentation
Develop, implement, and maintain manufacturing routers, work instructions, and Standard Operating Procedures (SOPs).
Create and update process flow diagrams and Process Failure Mode and Effects Analyses (PFMEAs).
Lead and support process validation activities (IQ/OQ/PQ) in compliance with ISO 13485 and FDA requirements.
Conduct First Article Inspections (FAI) and ensure complete documentation and traceability.
Collaborate with Quality to develop and maintain Production Part Approval Process (PPAP) documentation.
Evaluate existing tools and fixtures for effectiveness; design and develop new tooling and fixtures using CAD software (e.g., SolidWorks) as needed.
Design and implement incoming inspection processes for raw materials and components.
Monitor nonconforming materials, lead root cause investigations, and define appropriate rework or corrective actions.
Support and actively participate in Corrective and Preventive Action (CAPA) processes.
Conduct and analyze Statistical Process Control (SPC) studies to monitor, control, and improve process performance.
Training & Production Support
Train production personnel on new and revised manufacturing processes, procedures, and equipment.
Provide hands-on technical support to resolve production issues and improve process capability and efficiency.
Continuous Improvement
Partner with cross-functional teams to identify, prioritize, and implement process improvements.
Drive initiatives to reduce waste, improve efficiency, and enhance overall manufacturing performance.
Required Qualifications
Bachelor's degree in Mechanical, Manufacturing, Biomedical Engineering, or a related field.
3-5 years of experience in a regulated manufacturing environment, preferably within the medical device industry.
Strong working knowledge of ISO 13485 and FDA regulatory requirements.
Hands-on experience with process validation (IQ/OQ/PQ), FAI, PFMEA, SPC, and PPAP documentation.
Proficiency with CAD software, ERP systems, and Microsoft Office Suite.
Excellent technical documentation, communication, and organizational skills.
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.
