Manufacturing Engineering Manager

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 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

• 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 e 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

• 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

• Ensure compliance with FDA and ISO 13485 requirements
• Maintain manufacturing documentation and work instructions

• Bachelor's degree in Engineering or related technical field
• 8-10 years of manufacturing, sustaining, or product engineering experience
• Experience in sterile, disposable medical device and global contract manufacturing

• 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