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 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