Job description

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 e xecute 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 m edical device s 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

Requirements

Must-haves

Manufacturing Engineering Manager
This role reports to our downtown Seattle Corporate Office, onsite, with the ability to travel (up to 20% as needed.)
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 e xecute 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
Bachelor's degree in Engineering or related technical field

Nice-to-haves

None flagged.

Application prep

Use the role’s language and application details while tailoring your materials.

Platform: bamboohr
Effort: medium