Responsible for managing all aspects of a new product launch for surgical instruments, implantable devices, and delivery systems from opportunity review to production transfer. The position will lead customer and internal activities facilitating the product launch between the customer, supply chain, and company.
- Drives opportunity assessment and project proposals at project initiation.
- Oversees quoting activities including the process outline and costing.
- Leads project requirement checklists through justification and/or rationalization of activities associated with product launch.
- Owns project planning and timeline execution.
- Leads Design for Manufacturability (DFM) with the Client.
- Supervises Device Master Record (DMR) development and accuracy with associated process development and testing.
- Guides pFEMA development and team discussions along with managing the risk mitigation activities and testing.
- Supports purchasing in supply chain integration.
- Leads pre/post production meetings.
- Responsible for profitability of process and overall financial performance of the project within the control of AMG.
- Responsible for accurate information released to production to include, but not limited to, router, inspection sheets, in process prints, and fixtures.
- Assists in project tracking and metric development to monitor ongoing performance.
- Primary technical representative for the company with Client to negotiate product design and process deliverables.
- Practical implementation and monitoring of systems and procedures for meeting ISO standards and FDA quality system regulations.
- Works proactively with the team to share best-practices, and lessons learned.
- Fosters close and productive relationship with cross-functional counterparts.
- Understands project schedules for all projects that are within the department.
- Manages project team workload and activities.
- Work and travel with Business Development to solicit new program opportunities and maintain alignment of overall business strategies and long term goals.
- Drives the implementation of the Advanced Manufacturing Group methodologies corporate-wide.
Bachelor’s degree in Engineering preferred (Mechanical Engineering or Biomedical Engineering)
Minimum 5 years experience in new product development and commercialization within medical device manufacturing, ideally in orthopedics, is preferred.
Experience with tight tolerance methods in machining and measurement system applications, blueprint reading, GD&T, working knowledge of short run process control methods, statistical analysis, DOE, ISO standards and FDA quality system regulations.
Previous experience in similar leadership role is required.
Windows-based computer knowledge is required.
Minimum 2 years of experience in project management (strategic/tactical planning and implementation capabilities) coupled with strong technical and conceptual aptitude required. Knowledge of Design for Manufacturability (DFM) principles, biocompatibility requirements for materials, ISO 13485 and US QSR 21 CFR, Part 820 Medical Devices, and basic knowledge of the human anatomy preferred.
Knowledge of various metal and polymer materials as well as testing specifications preferred.