Sr Console Manufacturing Engineer

Gentuity•Bedford, MA

12d

About The Position

Lead Console Manufacturing operations ensuring adequate staffing, training and adherence to workmanship standards in a regulated medical device environment. Establish and enforce manufacturing controls to ensure strict procedural compliance, prevent non-conformances and maintain accurate, timely Device History Records (DHR’s). Plan and execute manufacturing builds to achieve monthly labor utilization and production targets. Supervise and develop a team of electronic equipment assemblers and technicians including task prioritization, training, qualification and performance management. Own and drive Non-Conformance (NCR) and CAPA processes end-to-end including investigation, root cause analysis, cross-functional action planning and timely closure. Troubleshoot returned goods and field failures including failure analysis, repair/rework definition, execution, verification testing and compliant documentation. Own electronics test strategy for production and service including: Defining test requirements and acceptance criteria Developing and maintaining test procedures Selecting and qualifying test equipment and fixtures Analyzing failures and ensuring traceable test records Lead equipment and process validation (IQ/OQ/PQ) activities ensuring compliance with regulatory and quality requirements. Manage product scale-up and design transfer from R&D to Manufacturing ensuring readiness for production. Provide Design for Manufacturability (DFM) input during product development including development of test methods and testbeds. Develop and maintain manufacturing documentation (BOMs, routers, work instructions, rework processes). Own supplier and component changes to support manufacturing continuity including: Identification of alternate suppliers/components Technical assessment and risk evaluation Qualification planning and execution Change control and documentation approvals Collaborate cross-functionally with R&D, Quality, Supply Chain and Finance to achieve departmental and organizational objectives. Drive continuous improvement initiatives focused on Quality, productivity, efficiency and cost reduction. Analyze and report manufacturing performance using metrics such as control charts, process capability, reliability, histograms and Pareto analysis. Investigate production issues and implement corrective and preventive solutions.

Requirements

Minimum of 7 years of experience in medical device manufacturing engineering or another regulated industry.
Demonstrated ownership of complex, cross-functional initiatives at a senior engineer level.
Experience manufacturing capital equipment (medical device preferred).
Experience in: Electronics test development and sustainment (test plans, procedures, fixtures, equipment qualification), Failure analysis and troubleshooting, Test data traceability and documentation compliance
Experience leading supplier/component changes including: Risk-based qualification approaches, Verification and validation impact assessment, Supplier evaluation and approval, Implementation via formal change control
Strong knowledge of FDA Medical Device Regulations (21 CFR Part 820), ISO 13485 and ISO 60601.

Nice To Haves

Six Sigma and IPC certifications are a plus.

Responsibilities

Lead Console Manufacturing operations ensuring adequate staffing, training and adherence to workmanship standards in a regulated medical device environment.
Establish and enforce manufacturing controls to ensure strict procedural compliance, prevent non-conformances and maintain accurate, timely Device History Records (DHR’s).
Plan and execute manufacturing builds to achieve monthly labor utilization and production targets.
Supervise and develop a team of electronic equipment assemblers and technicians including task prioritization, training, qualification and performance management.
Own and drive Non-Conformance (NCR) and CAPA processes end-to-end including investigation, root cause analysis, cross-functional action planning and timely closure.
Troubleshoot returned goods and field failures including failure analysis, repair/rework definition, execution, verification testing and compliant documentation.
Own electronics test strategy for production and service including: Defining test requirements and acceptance criteria, Developing and maintaining test procedures, Selecting and qualifying test equipment and fixtures, Analyzing failures and ensuring traceable test records
Lead equipment and process validation (IQ/OQ/PQ) activities ensuring compliance with regulatory and quality requirements.
Manage product scale-up and design transfer from R&D to Manufacturing ensuring readiness for production.
Provide Design for Manufacturability (DFM) input during product development including development of test methods and testbeds.
Develop and maintain manufacturing documentation (BOMs, routers, work instructions, rework processes).
Own supplier and component changes to support manufacturing continuity including: Identification of alternate suppliers/components, Technical assessment and risk evaluation, Qualification planning and execution, Change control and documentation approvals
Collaborate cross-functionally with R&D, Quality, Supply Chain and Finance to achieve departmental and organizational objectives.
Drive continuous improvement initiatives focused on Quality, productivity, efficiency and cost reduction.
Analyze and report manufacturing performance using metrics such as control charts, process capability, reliability, histograms and Pareto analysis.
Investigate production issues and implement corrective and preventive solutions.