Medical Device Process Engineer - Validation & Innovation (Onsite)

Pharmavise Corporation; Maple Grove (MN); On-site; USD 90,000 - 120,000; Full time

Job summary

Pharmavise Corporation in Maple Grove, MN seeks a Process Engineer to lead the clinical build line and own process development deliverables. The role focuses on process validation documentation and supporting commercialization activities.

You will collaborate with R&D, QA, Production, Regulatory, and Equipment Engineering on complex projects, designing tests, analyzing results, and communicating findings to the technical community.

Qualifications

• Leads process development and validation activities.
• Experience with Six Sigma methodologies and robust data analysis.
• Ability to work across R&D, QA, Production, Regulatory, and Engineering teams.

Responsibilities

• Leads clinical build line and owns process development deliverables.
• Manages process validation documentation from development through commercialization.
• Supports technology development, test of materials, and specification preparation.
• Selects process improvement techniques and recommends equipment changes.
• Summarizes and analyzes complex test results and communicates conclusions.

Skills

Process development

Six Sigma

Cross-functional collaboration

Tools

Keyance

Sensofar

Job description

Pharmavise Corporation in Maple Grove, MN seeks a Process Engineer to lead the clinical build line and own process development deliverables. The role focuses on process validation documentation and supporting commercialization activities.

You will collaborate with R&D, QA, Production, Regulatory, and Equipment Engineering on complex projects, designing tests, analyzing results, and communicating findings to the technical community.