Manufacturing Engineering Manager

Manufacturing Engineering Manager
Position Summary
The Manufacturing Engineering Manager is responsible for providing technical leadership and engineering support for commercialized products and outsourced manufacturing partners. This role ensures product quality, manufacturing excellence, regulatory compliance, and continuous improvement throughout the product lifecycle.
This role reports to our downtown Seattle Corporate Office, onsite, with the ability to travel (up to 20% as needed.)
Primary Responsibilities
Contract Manufacturing Management
Primary technical liaison with contract manufacturers
Support supplier sourcing, negotiation, qualification, audits, process reviews and issue resolution
Lead manufacturing transfers, change management, and capacity expansion activities
Cross functional program and project leadership
Sustaining Engineering
Experienced project management and design control / stage gate development processes
Provides specification analysis, component
selection and product structure organization
Utilize Solidworks and other software tools to execute design changes as necessary, updates, Drawings, BOM’s and ensure DHF and DMR are updated
Lead root cause investigations and CAPA activities
Analyze quality and field performance data
Drive yield improvement and scrap reduction initiatives
Manufacturing Engineering
Support IQ/OQ/PQ validations
Develop and optimize manufacturing processes
Identify and Implement DFM/DFA improvements
Actively manages intercompany resources and outside vendors in support of prototype fabrication, assembly, and validation testing
Quality & Compliance
Ensure compliance with FDA and ISO 13485 requirements
Maintain manufacturing documentation and work instructions
Required Qualifications
Bachelor's degree in Engineering or related technical field
8-10 years of manufacturing, sustaining, or product engineering experience
Experience in sterile, disposable medical devices and global contract manufacturing
Competencies
Familiarity with a variety of prototyping processes
Experience identifying and working with suppliers for a wide variety of medical device components.
Working understanding of FDA Quality Systems Regulations and product development within the regulated environment
Knowledgeable of statistical methods
Strong problem solving, technical leadership, communication, project management and cross-functional collaboration skills
Ability to analyze and provide simple solutions to challenging situations
Expertise in materials such as silicone, PVC, MABS, polypropylene, polycarbonate, TPEs highly desired
Ability to work onsite in our downtown Seattle office; some minimal travel (up to 20%) may be required occasionally
Ability to work in an office and laboratory setting, using computers, fine motor skills and excellent hand dexterity with the ability to lift up to 25 lbs. occasionally

Employment type
Full-Time

Work arrangement
No