Chameleon Technologies is supporting a search for a Senior Manufacturing Engineer in a 6+ month contract to support a growing medical device organization through a critical phase of product development, manufacturing scale-up, and supplier engagement.
This individual will play a key role partnering cross-functionally with engineering, operations, quality, and external contract manufacturers to support manufacturing readiness, product transfer activities, and process improvement initiatives within a regulated medical device environment.
Key Responsibilities
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Support manufacturing engineering initiatives for medical device products from development through production
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Partner with R&D and external contract manufacturers to support product transfer and manufacturing readiness activities
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Provide technical support and oversight to suppliers and contract manufacturing partners
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Evaluate manufacturability and support design-for-manufacturing/process improvement efforts
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Assist with process development, verification, validation, and continuous improvement initiatives
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Investigate manufacturing and supplier-related process issues and help drive corrective actions
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Collaborate closely with internal quality, operations, and engineering teams in a fast-paced environment
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Ensure manufacturing processes and documentation comply with FDA and ISO regulated environments
Required Qualifications
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Bachelor’s degree in Manufacturing Engineering, Mechanical Engineering, Industrial Engineering, or related field
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5+ years of manufacturing engineering experience within the medical device industry
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Strong understanding of FDA QSR, ISO 13485, and regulated manufacturing environments
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Experience supporting NPI, product transfer, and manufacturing scale-up initiatives
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Experience working with contract manufacturers and supplier partners
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Strong communication, collaboration, and problem-solving skills
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Ability to adapt quickly and operate effectively in fast-paced environments
Preferred Qualifications
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Experience supporting design transfer activities to contract manufacturers
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Familiarity with process validation, SPC, DOE, and Six Sigma methodologies
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Experience supporting molding, bonding, wire harness assembly, or final assembly/test operations
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Prior experience in high-growth or rapidly scaling medical device companies
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Six Sigma certification or related continuous improvement experience
Additional Information
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6+ month contract opportunity
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$70-80/hour W2
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Onsite role in Kirkland, WA
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Open/flex office environment
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Strong candidates only — prior medical device/FDA-regulated experience is required
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This role will interface heavily with external contract manufacturers from a technical/manufacturing perspective
