Manager, Device Engineering

ROLE SUMMARY
• Technical leader and people manager responsible for global Medical Device and Combination Product Lifecycle management including product and process change management and risk management
• Responsible for maintaining compliance between on-market products and their respective Design History File (DHF)
• Production site facing role; establishes priorities and communicates deliverables and timing

ROLE RESPONSIBILITIES
• Provide technical guidance for design changes, good documentation practices, process changes, risk management
• Plan design change projects, track progress, and communicate status to management
• Assess complexity of change, priority, and assign appropriate resources
• Determines and manages resource needs for projects across the network
• Manages direct or indirect reports through a matrix organization
• Liaison between Global Technology & Engineering, production sites, external supply, quality, co-development, tech transfer, and launch teams
• Identify, communicate, and develop mitigation strategies for
technical risks with key stakeholders per appropriate escalation thresholding
• Leads Design History File (DHF) enhancements / updates for specific device presentation / platform
• Identifies and executes continuous improvement activities for device presentation / platform and processes
• Train PGS site colleagues on product and process change management and risk management activities for product lifecycle
• Contributor to Annual Product Record Review (APRR)
• Represent device engineering on change / CAPA review board (CRB)

QUALIFICATIONS

Education:
• BS in Packaging/Mechanical/Chemical or related Engineering Science. Advanced degree preferred.

Experience:
• Minimum 5-8 years' experience in Medical Device or Combination Products Design Controls, Production, equivalent Technical Project Management or related field

Other:
• Ability to work independently and as a member of a team and in collaboration with other functional groups
• Strong technical knowledge of complex Medical Device and Combination Products technologies
• Ability to advance new processes and moderately complex methodologies
• Leverages excellent interpersonal and communications skills to review, discuss, and inform key stakeholders of concepts to drive informed decisions
• Analyzes complex technical issues and uses technical judgment to impact decision
• Agile learner of new processes
• Knowledge of regulations and ability to work within complex quality system requirements (design controls)
• Strong technical project manager, critical thinking, and problem solving skills
• Understanding of production and production systems in a GMP regulated environment
• Ability to build effective relationships with key site colleagues
• Demonstrated experience in project planning, management, and budgeting with an orientation towards building and leading effective teams

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Must be able to travel up to 30%

Other Job Details

• Last Date to Apply: October 1, 2020
• Telecommuting will be considered for the right candidate

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Engineering