Type:

full-time

Job Description:

Title:

Manufacturing Engineer Location:

Maple Plain, MN 55359 (Onsite)

Duration:

06 Months (Contract/Possible Extension)

Shift:

M-F 1st Shift (8AM-5PM)

Payrate:

$35 to $36.7/hr on W2 (depending on experience) Job Description This is an exciting opportunity for a well-rounded engineer to join a small team supporting a recently acquired medical device startup As a Manufacturing Engineer, you will support the development, validation, and scale-up of manufacturing processes for our innovative surgical device - directly contributing to product quality, efficiency, and patient outcomes In all actions, the Manufacturing Engineer will demonstrate a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented processes and procedures Entry to 5+ years engineering experience in manufacturing or process engineering, understand manufacturing metrics and continuous improvement tools (e.g., lean, DMAIC), Have hands-on experience scaling products from prototype to production is a benefit, skilled in fixture/tooling design and implementation Strong CAD and problem-solving skills, Familiarity with regulated medical device environments, Strong problem-solving skills, attention to detail, self-starter with proven ability to successfully work with minimal supervision, good teamwork and interpersonal skills, good written and verbal communication, ability to multitask, prioritize, and meet project deadlines with high attention to detail, SolidWorks proficiency desired, familiarity with 5s and

DMADV Physical Demands:

• Ability to lift up to 30 pounds Must be able to wear clean room clothing and work in a cleanroom environment as needed 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

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Manufacturing Engineer - Medical Devices