What are the responsibilities and job description for the Manufacturing Engineer II (Medical Device Project Management) position at Planet Pharma?
Manufacturing Engineer II (Medical Device Project Management)
Location: Draper, UT (On-site; open to non-local candidates willing to relocate at own expense)
Position Type: 1-Year Contract (May extend or convert to permanent)
$42/hour W2
Position Overview
In this hybrid hands-on and project leadership role, you will split your time between desk-based project coordination/documentation and on-the-floor manufacturing line support.
Working closely under the direct mentorship of senior leadership, you will help drive new product development (NPD), execute process validations, coordinate manufacturing builds, and optimize catheter manufacturing processes in a fast-paced medical device environment.
Key Responsibilities
- Project Management & Coordination (50%): Lead and support cross-functional project deliverables in collaboration with R&D, operations, and commercial teams using tools like MS Project. Track timelines, coordinate raw material allocations, and schedule builds.
- Engineering & Technical Documentation (25%–30%): Author and review high-quality engineering documentation, technical summaries, worker logs, specification sheets, and process validation protocols (IQ/OQ/PQ) ensuring strict FDA quality and compliance standards.
- Hands-on Line Support & Process Improvement (20%–40%): Spend active time in the manufacturing facility/cleanroom running builds, troubleshooting line issues, and supporting new product launches. Apply Lean and Six Sigma methodologies to continuously optimize processes, equipment, fixtures, and layouts.
Qualifications & Requirements
Education & Experience
- Education: Bachelor’s Degree in Engineering (Required).
- Experience:
- Ideally 2 to 4 years of professional engineering experience.
- Open to consideration: Candidates with strong internship background up to mid/senior-level experience (8–10 years), provided rate expectations fit within the target range.
Technical & Practical Skills
- Project Management: Proven experience or exposure using Microsoft Project to track deliverables, organize timelines, and support cross-functional team execution.
- Manufacturing & Compliance: Practical, hands-on experience in manufacturing operations.
- Prior experience in catheter manufacturing or medical devices is strongly preferred.
- Experience in other highly regulated, FDA-adjacent, or high-compliance industries (e.g., Aerospace, Food & Beverage) will also be considered.
- Cleanroom experience is a major plus (trainable on the job).
- Process Improvement: Practical experience applying Lean Manufacturing and Six Sigma tools (certifications are a plus, but practical application is key).
- Documentation & Technical Ability: Strong ability to read, interpret, and create engineering drawings, schematics, and process flow diagrams. Excellent technical writing skills for summary reporting and quality compliance.
Soft Skills
- Highly organized self-starter with excellent attention to detail.
- Adaptable and agile when project priorities or timelines shift.
- Exceptional written and verbal communication skills; natural team player.
Salary : $42