Pay Range: 27-37/hr
depending on exp
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
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
7-10+ years engineering experience in manufacturing or process engineering, understand manufacturing metrics and continuous improvement tools (e.g., lean, DMAIC)
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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
