The Sr. Manufacturing Engineer will provide focused project leadership and technical support to Operations with an emphasis on project management, equipment qualification, standard operating procedures, standard costing, capacity analysis, yield improvements, cost reduction, planning, validations and metrology.
The specific duties of the Sr. Manufacturing / Process Engineer include:
- Supports production to maintain inventory flow and levels to meet demand
- Addresses issues (e.g. NCR, CAPA) quickly and effectively
- Plans, leads, and executes complex cross functional projects impacting operations and other areas of the business
- Leads continuous improvements activities of productivity, quality, cost, cycle time and yield of raw material
- Leads efforts to maintain and improve quality of existing operations, processes, and products
- Represents operations on new product development teams. Develops and implements associated processes.
- Analyzes product or equipment specifications and performance requirements to determine feasibility of new plant equipment or modifying existing equipment
- May include reporting duties for multiple interns and/or engineers
- Analysis and recommendations for capital equipment investments
- Being a focal point for technical communications on quality issues
- Utilizing root cause analysis methods and statistical tools to resolve processing issues.
- Using statistical methods to determine in-control/out-of-control processes.
- Developing and implementing methods and procedures for inspecting, testing and evaluation of products for acceptability
- Leads the development and execution of equipment installation and operational qualifications.
- Leads in the development and execution of process validations.
- Leads in developing and maintaining support systems for production work processes
- Supporting integration of new business work processes
- Maintenance of the calibration program
Experience / Qualifications
- (Bachelors degree in Engineering or related science with 5 years experience.
- Medical device, biologic or HCTP experience required.
- 5 - 9 years in Manufacturing Engineering, Process Design Engineering, Process Optimization, or Process Development preferably with a regulated medical product.
- Proven project leadership / management skills required.
- Oral & written communications skills,
- Computer software skills including but not limited to: MS Office, database, Excel, and MS Project
- Lean manufacturing and/or process controls experience a plus.
- Willingness to process and handle human and animal tissue based products,
- Includes but is not limited to: verbal communication, typing, standing, sitting, walking, pushing, pulling, stooping, and seeing.
- Position will require travel up to 20% .