Manufacturing Engineer

Akkodis; Plano (TX); On-site; USD 62,000 - 66,000; Full time

Job summary

Akkodis is seeking a Sr. Manufacturing Engineer for a 12-month contract in Plano, TX. The role leads technical investigations, supports daily manufacturing operations, and ensures compliant, efficient processes in a regulated environment.

You will implement and validate new equipment, automation, and processes using IQ/OQ/PQ; mentor junior engineers; and collaborate with Production, Quality, R&D, and Supply Chain to drive quality, productivity and cost improvements.

Qualifications

• Bachelor's degree in mechanical or related engineering discipline.
• 5+ years of manufacturing engineering experience in a regulated industry.
• Experience leading manufacturing support activities and cross-functional projects.
• Experience performing IQ/OQ/PQ validations.
• Experience with root-cause analysis methodologies.

Responsibilities

• Lead troubleshooting of complex manufacturing, process, and equipment issues.
• Analyze yield, scrap, defect, and process data to drive improvements.
• Lead root cause investigations using structured methods.
• Plan and execute IQ/OQ/PQ validations.
• Mentor junior engineers and coordinate cross-functional teams.

Skills

Technical troubleshooting

Data analysis

Cross-functional leadership

Root cause analysis

Communication skills

Education

Bachelor's degree in Mechanical Engineering

Tools

Minitab

JMP

MES/ERP systems

Job description

Akkodi's is seeking a Sr. Manufacturing Engineer for a 12 Months contract position with a client located in Plano, TX (75024). Medical device, pharmaceutical, biotechnology, or other highly regulated manufacturing experience comes as a plus.

Job Title : Sr. Manufacturing Engineer

Duration : 12 Months

Pay Range: $45/hour - $48/hour on w2 (without benefits); the rate may be negotiable based on experience, education, geographic location and other factors.

Job Summary:

The Manufacturing Engineer serves as a technical leader supporting daily manufacturing operations through advanced troubleshooting, data-driven decision making, yield improvement, defect reduction, and implementation of robust manufacturing processes. This engineer independently leads complex investigations, drives cross-functional problem solving, and identifies opportunities to improve operational performance, quality, and cost.

The engineer will lead the implementation and validation of new equipment, automation, and manufacturing processes utilizing the IQ/OQ/PQ framework and applicable regulatory requirements. They will partner closely with Production, Quality, R&D, Supply Chain, and other cross-functional teams to ensure compliant, efficient, and scalable manufacturing operations. The engineer is expected to serve as a subject matter expert, mentor junior engineers, and communicate technical findings and business impacts to all levels of the organization, including senior leadership.

• Lead troubleshooting of complex manufacturing, process, and equipment-related issues to minimize downtime and maintain production objectives.
• Analyze yield, scrap, defect, and process performance data to identify trends and drive sustainable improvements.
• Lead root cause investigations using structured problem-solving methodologies such as 6M, 5 Why, Fishbone, DOE, and statistical analysis tools.
• Drive continuous improvement initiatives focused on quality, productivity, cost reduction, capacity expansion, and process robustness.
• Lead cross-functional teams in the execution and implementation of corrective and preventive actions (CAPA).
• Plan, execute, and document equipment and process validations using IQ/OQ/PQ methodologies.
• Develop and optimize manufacturing processes, work instructions, control plans, and standard operating procedures.
• Provide technical mentorship and guidance to junior engineers and manufacturing personnel.
• Assess and implement automation, tooling, and process improvements to enhance operational efficiency.
• Communicate project status, technical findings, recommendations, and business impact to stakeholders and leadership.
• Ensure compliance with FDA, ISO, GMP, and internal quality system requirements.

Must Have:

• Excellent or native English language fluency due to all meetings, procedures, and technical communications being conducted in English.
• Demonstrated ability to influence and collaborate effectively with cross-functional teams and stakeholders at all organizational levels.
• Proven experience leading technical investigations and driving issue resolution in a manufacturing environment.
• Strong analytical and problem-solving skills with the ability to make data-driven decisions independently.

Required Experience:

• Bachelor's degree in Mechanical Engineering (preferred), Industrial Engineering, Electrical Engineering, Chemical Engineering, Bioengineering, or related engineering discipline.
• 5+ years of manufacturing engineering experience, preferably in a regulated industry.
• Experience leading manufacturing support activities, process improvements, and cross-functional projects.
• Experience performing equipment and process validations (IQ/OQ/PQ).
• Experience utilizing structured root cause analysis methodologies and implementing corrective actions.

Top 5 Key Skills:

• Advanced technical problem-solving and troubleshooting
• Statistical data analysis and process optimization
• Cross-functional leadership and project management
• Root cause analysis and corrective action implementation
• Strong verbal, written, and presentation communication skills.

Preferred Experience:

• Medical device, pharmaceutical, biotechnology, or other highly regulated manufacturing experience.
• Lean Manufacturing, Six Sigma Green Belt or Black Belt certification.
• Advanced statistical analysis using Minitab, JMP, or similar software.
• Experience with automation, robotics, vision systems, or advanced manufacturing technologies.
• MES, ERP, and manufacturing data systems experience.
• Design of Experiments (DOE), process characterization, and validation expertise.
• Experience mentoring engineers, technicians, and production personnel.
• Experience leading capital equipment implementation projects.

Equal Opportunity Employer/Veterans/Disabled

Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, an EAP program, commuter benefits, and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable. Disclaimer: These benefit offerings do not apply to client-recruited jobs and jobs that are direct hires to a client.

To read our Candidate Privacy Information Statement, which explains how we will use your information, please visit https://www.akkodis.com/en/privacy-policy.

The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:

The California Fair Chance Act

Los Angeles City Fair Chance Ordinance

Los Angeles County Fair Chance Ordinance for Employers