Medical Device Sustaining Engineering Lead

Protingent; Kennewick (WA); On-site; USD 140,000 - 165,000; Full time

Job summary

Protingent is seeking a Sustaining Engineering Manager to lead the Engineering Laboratory team in maintaining and improving medical device designs. You will guide sustaining efforts, support prototyping and testing for development projects, and drive design verification, failure analysis, and change control.

You will mentor technicians and engineers, grow a technically versatile team, and coordinate with Production, Procurement, and Manufacturing Engineering to ensure product quality and

Qualifications

• Engineering leadership and development of procedures and work instructions.
• PCB design knowledge from concept to manufacturing transfer including DFM/DFT.
• Electrical engineering principles including failure analysis and reliability.
• Knowledge of embedded circuits and sensors.
• Regulatory compliance and QMS for Medical Device.
• Hardware development lifecycle including deployment to production.
• Strong planning, organization, and risk management.

Responsibilities

• Lab Team Ownership: Oversees and leads the Engineering Laboratory team in supporting both new development and post-release sustaining of the medical devices; includes failure analysis, design verification testing, component management, production/procurement support, design improvements, and releasing new and updated engineering design
• Team Leadership & Growth: Provides mentorship and guidance to Laboratory Technicians and Engineers, assisting in their technical development and strategically growing and diversifying skills and team composition to best support the success
• Manage and Monitor Resources: Oversees and actively manages Engineering Laboratory resources to ensure they are efficiently applied to both projects and smaller supporting activities; continuously evaluates team, outputs, and workload to proactively identify and communicate resource needs and schedule impacts, adjusting plans and priorities as needed
• Reactive Work Management: Ensures timely resolution of engineering support escalations from other departments, as well as externally sourced escalations from the vendors
• Sustaining Change Planning and Oversight: Leads engineering change control efforts for released designs, chairing change control activities and crossfunctionally coordinating with Production, Procurement, and Manufacturing Engineering as necessary to ensure success
• Laboratory Systems Ownership: Provides leadership on and direction for the systems (standards, processes, checklists, and tools) used by the Engineering Laboratory team; continuously monitors and manages the performance of the Engineering Laboratory team and systems against set goals
• Technical Expertise: Maintains strong technical skillset to evaluate, guide, and continually improve the team’s produced work; ensures that work quality meets the design standards and industry best practices
• Inter-team Collaboration: Partners with other departments such as Procurement, Manufacturing, Service, Software & Hardware Engineering, Regulatory Affairs, Quality Assurance, and Supplier Quality Engineering to ensure they are supported as needed
• Regulatory and Process Compliance: Ensure the team’s processes, trainings, and outputs align with applicable regulations (FDA 21 CFR Part 820, ISO 13485, etc.) and the processes; supports internal and external audits from FDA and Notified Bodies
• Perform other duties as assigned.

Skills

Engineering leadership

PCB design

Electrical engineering principles

Embedded circuits

Regulatory compliance

Hardware development lifecycle

Planning & leadership

Risk management

Education

B.S. in Electrical Engineering

10+ years engineering management experience

Experience designing regulated equipment

Job description

Protingent is seeking a Sustaining Engineering Manager to lead the Engineering Laboratory team in maintaining and improving medical device designs. You will guide sustaining efforts, support prototyping and testing for development projects, and drive design verification, failure analysis, and change control.

You will mentor technicians and engineers, grow a technically versatile team, and coordinate with Production, Procurement, and Manufacturing Engineering to ensure product quality and