Manufacturing Process Engineer

TechDigital Group; Liberty (SC); On-site; USD 90,000 - 125,000; Full time

Job summary

An established industry player is seeking a skilled Manufacturing Engineer with a strong background in medical devices. In this role, you will leverage your expertise in process validations and data analysis to develop and enhance manufacturing processes. Your ability to work collaboratively in a fast-paced environment, coupled with your attention to detail and strong communication skills, will be key to your success. Join a forward-thinking company that values innovation and compliance with regulatory standards, providing you with the opportunity to make a significant impact in the medical device sector.

Qualifications

• 5+ years of experience in Medical devices manufacturing engineering.
• Strong communication skills and ability to work in a team.

Responsibilities

• Develop manufacturing processes and technologies including process characterization.
• Comply with FDA regulations and company policies.
• Experience developing manufacturing processes and technologies, which includes process characterization.
• Experience in PFMEA.
• Experience in Data analysis (Minitab).
• Evaluate process and design alternatives based on Design for Manufacturability principles.
• Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
• Multitasks, prioritizes and meets deadlines in timely manner.
• Strong organizational and follow-up skills, as well as attention to detail.
• Understand principles of "Cost of Goods Sold".
• Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.

Skills

Medical devices - Manufacturing Engineering

Process Validations (IQ, OQ, PQ)

Data analysis (Minitab)

Process characterization

PFMEA

Verbal and written communication

Organizational skills

Tools

Minitab

Job description

Job Responsibilities

Minimum 5 years of Medical devices - Manufacturing Engineering experience.

Good Experience working on Process Validations (IQ, OQ, PQ).

Experience developing manufacturing processes and technologies, which includes process characterization.

Experience in PFMEA.

Experience in Data analysis (Minitab).

Evaluate process and design alternatives based on Design for Manufacturability principles.

Ability to work within a team and as an individual contributor in a fast-paced, changing environment.

Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.

Multitasks, prioritizes and meets deadlines in timely manner.

Strong organizational and follow-up skills, as well as attention to detail.

Understand principles of "Cost of Goods Sold".

Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.