Manufacturing Engineer: Medical Device Process & Compliance

Equinox It Solutions LLC.; Dallas (TX); On-site; USD 92,415 - 125,031; Full time

Job summary

Equinox It Solutions LLC. is seeking a Manufacturing Engineer to design controls, remediate design history files, and optimize processes for healthcare or pharmaceutical products. The role involves developing verification tests, performing reviews, and drafting reports to meet industry standards.

Travel and relocation to client sites across the USA are required. A Master's degree in a related field with six months of experience is needed to qualify for this position.

Qualifications

• Master's degree in Manufacturing/ Chemical/ Industrial engineering or closely related field.
• Six months of experience in manufacturing engineering, chemical engineering, validation engineering or industrial engineering.
• Willingness to travel/relocate to client sites across the USA.

Responsibilities

• Design controls methodologies and optimize design/process requirements for healthcare or pharmaceutical industry.
• Develop design verification test plans and perform tests per design input requirements.
• Draft verification test reports for various tests and ensure compliance with medical device standards.
• Support manufacturing process development & qualification for new product commercialization and changes.
• Manage IQ/OQ/PQ protocols and reports for existing and new processes.
• Evaluate environmental health and safety for tools and products.

Education

Master's degree in Manufacturing Engineering or Chemical Engineering or Industrial Engineering or closely related field

Job description

Equinox It Solutions LLC. is seeking a Manufacturing Engineer to design controls, remediate design history files, and optimize processes for healthcare or pharmaceutical products. The role involves developing verification tests, performing reviews, and drafting reports to meet industry standards.

Travel and relocation to client sites across the USA are required. A Master's degree in a related field with six months of experience is needed to qualify for this position.