Medical Device Engineering & Research Lead

Polluxa, Inc.; Seattle (WA); On-site; USD 140,000 - 190,000; Full time

Job summary

Polluxa, Inc. in Seattle seeks an Engineering and Research Manager to oversee all engineering and research activities, guiding design, implementation, testing, and manufacturing oversight from prototype to commercial product.

The role requires leading cross-functional teams, developing validation strategies, managing vendors, and interfacing with clinical, marketing, and sales to refine inputs and ensure quality and timely product delivery.

Qualifications

• Minimum of 5+ years in the medical device industry, 8+ years desirable.
• Minimum 2+ product development and manufacturing projects completed (from prototype to commercial sale).
• Experience working with disposables and adhesive based products desirable.

Responsibilities

• Lead product development activities at contract design & manufacturing facilities. Interface with project teams and management at contract facilities to align activities with program requirements.
• Develop project plans, specifying goals, strategy, resource priority, and identification of program risks. Oversee activities throughout concept, development, verification, and launch.
• Develop validation and verification strategies for engineering projects. Ensure project design and manufacturing deliverables are in compliance with Quality System Requirements, and applicable Industry and Regulatory Standards and Guidance Documents.
• Design development and manufacturing plans with outside vendors.
• Manage vendors currently engaged in development and manufacturing functions.
• Provide clear communication to internal organization of product development activities, appropriate escalation of challenges to senior management, and data driven issue resolution.
• Provide medical device development expertise to resolve engineering and technical issues.
• Assist in identification of next generation product changes and development of product portfolio.
• Interface with physicians, marketing, sales, and clinical teams to refine design inputs. Ensure customer inputs are incorporated and maintained throughout the product development cycle.

Skills

Quantitative modelling

Test and validation planning

Project management

Product development lifecycle

Education

Bachelor’s Degree in Engineering

Master’s Degree desirable

Tools

Finite element analysis software

Job description

Polluxa, Inc. in Seattle seeks an Engineering and Research Manager to oversee all engineering and research activities, guiding design, implementation, testing, and manufacturing oversight from prototype to commercial product.

The role requires leading cross-functional teams, developing validation strategies, managing vendors, and interfacing with clinical, marketing, and sales to refine inputs and ensure quality and timely product delivery.