Manufacturing Engineering Manager

Magnolia Medical Technologies; Seattle (WA); Hybrid; USD 120,000 - 180,000; Full time

Job summary

Magnolia Medical Technologies is seeking a Manufacturing Engineering Manager to provide technical leadership for commercial products and outsourced manufacturing partners. The role ensures product quality, manufacturing excellence, regulatory compliance, and continuous improvement across the product lifecycle.

Based in downtown Seattle, onsite with up to 20% travel. Responsibilities include coordinating with contract manufacturers, leading transfers and capacity expansion, and advancing quality

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 device and global contract manufacturing.

Responsibilities

• Technical liaison with contract manufacturers.
• Lead manufacturing transfers, change management and capacity expansion.
• Support supplier sourcing, qualification, audits, process reviews and issue resolution.
• Develop and optimize manufacturing processes; implement DFM/DFA improvements.
• Validate IQ/OQ/PQ and ensure compliance with FDA/ISO 13485.
• Maintain DHF and DMR; lead CAPA and root cause investigations.
• Actively manages intercompany resources and outside vendors for prototype fabrication and validation.
• Provide cross-functional program and project leadership.

Skills

Project management

Cross-functional collaboration

Problem solving

Quality systems

Statistical methods

Communication

Education

Bachelor's degree in Engineering

Tools

SolidWorks

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

• 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 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 device 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