Under the direction of the Director of Manufacturing, the Senior Engineer will lead engineering staff, process improvement initiatives, and manage multiple organization projects.
The Senior Engineer will remain up-to-date on all applicable regulations and standards, ensuring the processes maintain compliance.
Essential Functions
Engineering Systems Development & Management of Processes
Process Improvement and Troubleshooting
Provide data analysis, including statistical analysis, when required
Development of policies or standard operating procedures (SOP's)
Use of root cause analysis tools
Use engineering principals and scientific expertise to provide solutions to a broad range of challenges
Project Management Leadership and/or Support
Serve as a Point-of-Contact (POC) on multiple projects as the technical lead
Ensure project plans comply with B&L, FDA, other regulatory agency, and ISO design control requirements
Ensure projects adequately meet design, development, technology transfer, validation, and post launch requirements
Validations and Design Controls
In conjunction with R&D, work through product development and/or commercialization
Technology Transfer and Scale-Up
Drive and apply principles for new product/manufacturing process development activities to ensure effective, efficient and complaint transfer to manufacturing operations
Review and approve equipment qualification protocols, product/process specifications, analytical method qualifications, development engineering protocols, validation strategies/protocols
Communication & Leadership within department and company-wide
Functional management and leadership of direct reports within team
Work collaboratively and cross-functionally with various departments
Provide mentorship and guidance to engineers
Personnel Development: Work with direct reports to establish goals and objectives related to company goals
Qualifications:
Requirements
BS in Engineering (biomedical, chemical, or related concentration)
Mid-level career, 5+ years in a regulated industry, preferred medical device or pharmaceutical industry
Strong interpersonal and organizational skills; excellent attention to detail
Preferred knowledge relevant regulations and standards (GMP, ISO, FDA, Medical Device etc.)
Experience with Root Cause Analysis and Failure Analysis
Experience in PFMEAs or other Risk Management Systems
Knowledge of project organization and management tools
Excellent oral, written, and interpersonal communication skills
Physical demands:
Must be able to stand for the full duration of a shift
Must be able to lift a minimum of 25 pounds
Mental demands:
Must be able to manage multiple tasks and prioritize workload
