Process Development Engineer

United Pharma Technologies Inc; Town of Texas (WI); On-site; USD 90,000 - 135,000; Full time

Job summary

United Pharma Technologies Inc. is seeking an experienced Process Development Engineer to support the development, optimization, and validation of manufacturing processes for medical device products.

The role emphasizes cross-functional collaboration with R&D, Manufacturing, and Operations to translate designs into robust, manufacturable processes. The ideal candidate will have 8+ years in process development, strong process validation experience, and a hands-on problem-solving approach.

Qualifications

• 8+ years of Process Development Engineering experience.
• Strong experience with process validation and New Product Introduction (NPI).
• Medical Device industry experience required; Class II or Class III device experience preferred.
• Proven experience working with R&D, Manufacturing, and Operations teams.
• Strong problem-solving skills with a hands-on approach.
• Ability to quickly learn new processes and technologies.
• Must be willing to work fully onsite in Plano, TX.

Responsibilities

• Lead process development and improvement initiatives for new and existing medical device products.
• Support New Product Introduction (NPI), process validation, and manufacturing transfer activities.
• Partner with R&D teams to translate product designs into robust and manufacturable processes.
• Collaborate with Production and Operations teams to troubleshoot manufacturing issues and improve process performance.
• Develop and execute process qualification and validation activities, including IQ/OQ/PQ as applicable.
• Identify opportunities for process optimization, yield improvement, and cost reduction.
• Create and maintain engineering documentation, validation protocols, and reports in compliance with quality and regulatory requirements.
• Support root cause investigations, CAPA activities, and continuous improvement initiatives.

Skills

Process development

Process validation

NPI

Cross-functional collaboration

Problem solving

Hands-on

On-site

Job description

We are seeking an experienced Process Development Engineer to support the development, optimization, and validation of manufacturing processes for medical device products. The ideal candidate will have strong experience in process development, NPI, process validation, and cross-functional collaboration with R&D, Manufacturing, and Operations teams.

Key Responsibilities:

• Lead process development and improvement initiatives for new and existing medical device products.
• Support New Product Introduction (NPI), process validation, and manufacturing transfer activities.
• Partner with R&D teams to translate product designs into robust and manufacturable processes.
• Collaborate with Production and Operations teams to troubleshoot manufacturing issues and improve process performance.
• Develop and execute process qualification and validation activities, including IQ/OQ/PQ as applicable.
• Identify opportunities for process optimization, yield improvement, and cost reduction.
• Create and maintain engineering documentation, validation protocols, and reports in compliance with quality and regulatory requirements.
• Support root cause investigations, CAPA activities, and continuous improvement initiatives.

Required Qualifications:

• 8+ years of Process Development Engineering experience.
• Strong experience with process validation and New Product Introduction (NPI).
• Medical Device industry experience required; Class II or Class III device experience preferred.
• Proven experience working with R&D, Manufacturing, and Operations teams.
• Strong problem-solving skills with a hands-on approach.
• Ability to quickly learn new processes and technologies.
• Must be willing to work fully onsite in Plano, TX.