Manufacturing Engineer
Katalyst Healthcares and Life Sciences
Job Description:
Role Summary:
Role Summary:
- The Manufacturing Engineer will support equipment and process validation activities (IQ/OQ/PQ) for a medical device production facility.
- The role involves ensuring that manufacturing systems, equipment, and processes meet regulatory, quality, and performance standards while supporting production readiness and compliance.
- Execute and support Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) activities for manufacturing equipment and processes
- Develop, review, and execute validation protocols and reports in compliance with FDA and regulatory standards.
- Coordinate with cross-functional teams (Quality, R&D, Production, and Validation teams) for successful validation execution.
- Support equipment installation, commissioning, and troubleshooting activities
- Ensure adherence to Good Manufacturing Practices (GMP) and quality systems
- Perform risk assessments (FMEA) and contribute to process improvements
- Maintain accurate documentation, traceability, and validation records
- Participate in process optimization and continuous improvement initiatives
- Support audits, inspections, and regulatory submissions as needed
- Bachelor's degree in engineering (Mechanical / Electrical / Biomedical / Manufacturing) or equivalent experience with 3+ years' experience
- Strong understanding of IQ/OQ/PQ methodologies and validation lifecycle
- Knowledge of medical device regulations (FDA, ISO 13485)
- Experience in manufacturing processes, equipment qualification, and process validation
- Familiarity with GMP, CAPA, and change control processes
- Ability to read and interpret engineering drawings, P&IDs, and technical specifications
- Strong problem-solving and analytical skills
- Excellent communication and documentation skills
- Experience in medical device or regulated manufacturing environment
- Exposure to cleanroom manufacturing environments
- Familiarity with statistical tools and validation software
- Experience supporting automation systems or complex manufacturing equipment
- Full-time onsite role in a regulated medical manufacturing facility
- Requires collaboration with cross-functional teams and shop-floor presence
- Approved IQ/OQ/PQ protocols and reports
- Equipment qualification and validation documentation
- Compliance with regulatory and quality standards
- Timely execution of validation and production readiness activities
Vacancy posted 3 days ago
Similar jobs that could be interesting for youBased on the Manufacturing Engineer in Marietta, GA vacancy
- ...Title : Manufacturing Engineer Location : Marietta, GA Contract : 12Month Contract with potential extension Citizenship Requirement : US Citizenship required Shift : 4/10 1st Shift Pay : $60.00/hr - $80.00/hr on W2!...SuggestedFull timeContract workShift workDay shift
Trispoke Managed Services Pvt Ltd
Marietta, GA3 days ago - ...Job Description A well-established manufacturer is searching for a Manufacturing Engineer to join their team! A leader in their respective markets while also committed to both customers and employees. Great benefits and a fantastic work environment with long-term...Suggested
gpac
Marietta, GA5 days ago - Bachelor’s degree in Engineering (Mechanical / Electrical / Biomedical / Manufacturing) or equivalent experience with 3+ years experience Strong understanding of IQ/OQ/PQ methodologies and validation lifecycle Knowledge of medical device regulations (FDA, ISO 13485) Experience...Suggested
$140k - $180k
Senior Manufacturing Engineer needed for very reputable, high growth aerospace systems manufacturing leader! Salary: $140,000 - $180,000 per year Founded many decades ago and globally renowned for engineering excellence, we are a leader in bleeding edge aerospace systems...SuggestedLocal area- Jobot is seeking a Senior Manufacturing Engineer for a leading aerospace systems manufacturer in the United States. The role focuses on owning the manufacturing value chain, optimizing lean shop floor layouts, and driving improvements across design, manufacturing, and...Suggested
- ...Solutions is seeking a qualified candidate in Marietta, Georgia, who possesses a Bachelor's degree in Engineering and 3+ years of experience in validation and manufacturing processes. The ideal candidate should have a strong understanding of IQ/OQ/PQ methodologies and...
- Katalyst CRO in Marietta, Georgia is seeking a Manufacturing Engineer to support validation activities for medical device production. The role focuses on ensuring manufacturing systems and processes meet regulatory and quality standards. The ideal candidate will have a...Full time
- Overview Manufacturing Engineer - Electrical Planner Level 2 for the Electrical Pre‑Planning Team. This role initiates manufacturing planning activities and establishes the foundation for successful product‑interface execution. What You Will Be Doing Lead the early‑stage...Full timeWork at officeRemote workRelocationFlexible hoursShift work
- ...Manufacturing Engineer Established company with a very large market share in what they manufacture and that has a good working culture has an opportunity for a Manufacturing Engineer at a plant site in the southwest area of the Atlanta, GA metropolitan area. Much investment...Work at officeFlexible hours
McBride Executive Search and Selection
Atlanta, GA2 days ago - ...the United States most advanced drones and interceptors? PBS Aerospace is a rapidly growing designer and manufacturer of world-class small turbojet engines. These engines provide superior power-to-weight ratios with low fuel consumption making them the preferred choice...Internship
PBS AEROSPACE Inc
Roswell, GA5 days ago - ...Advanced Manufacturing Engineer You've discovered something special. A company that cares. Cares about leading the way in construction, engineering, manufacturing and renewable energy. Cares about redefining how energy is designed, applied and consumed. Cares about...Full timeMonday to FridayFlexible hours
Faith Technologies
Smyrna, GA5 days ago - ...Job Description Responsibilities The Manufacturing Engineer / Design Engineer will design, develop, and enhance manufacturing processes that meet product requirements. Collaborate with equipment vendors and conduct research to develop safe and efficient...
Southern Recruiting Solutions Inc
Atlanta, GA1 day ago $53 per hour
Manufacturing Engineer (Contract-to-Hire Potential) Pay Rate: $53.00+/hour based on experience Ready to make a real impact in a regulated, high-performance manufacturing environment? We are seeking a Manufacturing Engineer to support production operations, improve...Contract workFor contractorsLocal areaAdvantage Technical
Johns Creek, GA4 days ago- As the Manufacturing Engineer you will be responsible for designing, improving, and supporting hand‑assembly manufacturing processes for electronic IOT cameras and video products, solar power systems and mounting solutions to provide documentation and security services...Contract workFor contractorsCasual work
- Manufacturing Engineer - Stamping, Die Cast or Finishing Atlanta, Georgia Job ID: j-13169 | Type: Direct Hire | Remote: On‑Site | Compensation: $1 - $1 / yr GENERAL SUMMARY Established company with a very large market share in its manufacturing industry and a strong...Work at officeRemote workFlexible hours
- A well-established manufacturing company in Atlanta seeks a Manufacturing Engineer to design manufacturing processes and implement improvements. The role emphasizes teamwork and a mix of automation and tooling experience. Ideal candidates should possess a Bachelor's Degree...
$111k - $167k
..., sensor fusion, and networking technology to the military in months, not years. About The Team Anduril’s Manufacturing team is seeking a Manufacturing Engineer to join our team. The Manufacturing Team is responsible for rapidly iterating and building cutting‑edge defense...Contract work$85k - $140k
Hermeus is a high-speed aircraft manufacturer focused on the rapid design, build, and test of high-Mach and hypersonic aircraft for the... ...vehicle that will fly. We provide crucial design feedback to our engineering team and can rapidly iterate on design and assembly. The...Weekly payPermanent employmentWork at officeWeekend work$68.91k - $161.54k
At Capgemini Engineering, the world leader in engineering services, we bring together a global team of engineers, scientists, and architects... ...in Mobile, Alabama. About The Job You're Considering As a Manufacturing Engineer, you’ll play a key role in optimizing manufacturing...Local area- We’re Hiring: Manufacturing Engineer | U.S. Assignment Opportunity. Are you ready to take your manufacturing expertise to an international level? We are looking for a Manufacturing Engineer to lead the implementation and start-up of assembly and manufacturing lines for...For contractorsLocal areaRelocation packageWeekend work
- Capgemini is seeking a Manufacturing Engineer for an onsite role in Mobile, Alabama. You will optimize manufacturing systems to enhance productivity and quality across clients’ operations. Your responsibilities include developing industrial engineering strategies, conducting...
$68.91k - $161.54k
Manufacturing Engineer (Onsite: Mobile, Alabama) At Capgemini Engineering, the world leader in engineering services, we bring together a global team of engineers, scientists, and architects to help the world’s most innovative companies unleash their potential. About the...Full timeLocal area$120k - $172k
Minimum Qualifications Bachelor's degree in Electrical Engineering, Computer Science, or equivalent engineering experience. 5 years... ...engineering or equivalent. Experience developing and integrating manufacturing test hardware using custom electronics, fixturing, and...Local area$25 - $33 per hour
...need to maintain a durable, asymmetric advantage. About The Role: Hermeus is seeking talented students to join our Manufacture Engineering team in Atlanta. Fall: Around 16 weeks (August - December) Responsibilities: Work with experienced engineers...Hourly payWeekly payPermanent employmentInternshipWork at officeHermeus
Atlanta, GA3 days ago$30 - $40 per hour
...Manufacturing Engineer Intern Anduril Industries is a defense technology company with a mission to transform U.S. and allied military capabilities with advanced technology. By bringing the expertise, technology, and business model of the 21st century's most innovative...Full timeWork experience placementSummer workInternshipImmediate startColorwave Inc
Atlanta, GA2 days ago- ...in aerospace propulsion systems, including advanced turbojet engines such as the TJ80 and TJ100, auxiliary power units (APUs), and... ...Defense drone and missile systems. With the launch of our new U.S. manufacturing facility in Roswell, Georgia, we are assembling a world-class...Work experience placementLocal area
$130k - $180k
...ourselves. Because of this, we have a very tight loop between engineering and our customers (our own internal operations), and so can... ...worked thus far but won’t scale because the load of caring about manufacturing throughput and tooling maintenance has grown large enough...Work at officeFlexible hours1 day per week- ...diagnostics at the point of need, expanding availability and changing how healthcare is delivered. In-Person Position The Manufacturing Quality Engineer is responsible for ensuring that manufacturing processes meet applicable regulatory and internal quality requirements....
OXOS Medical
Atlanta, GA3 days ago $130k - $180k
WindBorne Systems in Redwood Shores is seeking a Manufacturing Engineer to own the engineering processes for newly designed parts. You will oversee the transition from design to manufacturing, ensuring quality and efficiency. The ideal candidate will have 5+ years of experience...- ...automated intralogistics solutions. With over 2,000 employees worldwide and a reputation for engineering excellence, Stow enables the backbone of global logistics and manufacturing, from advanced storage systems to large-scale warehouse optimization. Backed by a strong...WorldwideRelocation packageWeekend work
stow Group
Atlanta, GA2 days ago
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Manufacturing Engineer. Be the first to apply!
Related searches
- fabrication estimator Marietta, GA
- manufacturing positions Marietta, GA
- entry level manufacturing positions Marietta, GA
- manufacturing customer service representative Marietta, GA
- vice president manufacturing operations Marietta, GA
- controller manufacturing Marietta, GA
- project manager fabrication Marietta, GA
- manufacturing analyst Marietta, GA
- fabrication technician Marietta, GA
- aircraft manufacturing Marietta, GA