Senior Medical Device Manufacturing Engineer – Scale-Up

Creative Solutions Services, LLC; Maple Plain (MN); On-site; USD 110,000 - 150,000; Full time

Job summary

Creative Solutions Services, LLC in Maple Plain, MN, is seeking a Sr Manufacturing Engineer to lead the development, validation, and scale-up of manufacturing processes for a medical device startup. The role focuses on process improvement, DFM, and ensuring patient safety and product quality in a fast-paced environment.

The engineer will drive cross-functional collaboration with R&D, Quality, and Supply Chain, manage special projects, and implement robust processes for high-volume production,

Qualifications

• 7–10+ years of engineering experience in manufacturing or process engineering.
• Understand manufacturing metrics and continuous improvement tools (e.g., Lean, DMAIC).
• Hands-on experience scaling products from prototype to production is a benefit.
• Skilled in fixture/tooling design and implementation.

Responsibilities

• Manage special projects and initiatives as assigned, driving them from planning through implementation and final completion.
• Lead development and optimization of manufacturing processes for soft-tissue repair device systems.
• Drive design for manufacturability (DFM) and transfer of robust processes into high-volume production.
• Develop and validate equipment, fixtures, and tooling for assembly and inspection.
• Partner cross-functionally with R&D, Quality, and Supply Chain to resolve technical issues and improve output.
• Execute structured root-cause analysis and corrective actions for production challenges.
• Support process validations, change controls, and documentation in compliance with ISO 13485/FDA QSR.

Skills

CAD

Problem-solving

Regulated environment

Teamwork

Communication

Multitasking

SolidWorks

5S

DMADV

Tools

SolidWorks

Job description

Creative Solutions Services, LLC in Maple Plain, MN, is seeking a Sr Manufacturing Engineer to lead the development, validation, and scale-up of manufacturing processes for a medical device startup. The role focuses on process improvement, DFM, and ensuring patient safety and product quality in a fast-paced environment.

The engineer will drive cross-functional collaboration with R&D, Quality, and Supply Chain, manage special projects, and implement robust processes for high-volume production,