Principal Engineer

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Principal Engineer

@ Tides Medical

Description

• Under the direction of the Director of Manufacturing, the Principal Engineer will lead engineering staff, process improvement initiatives, and manage multiple organization projects.
• The Principal 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
• Use of root cause analysis tools
• Use engineering principals and scientific expertise to provide solutions to a broad range of problems
• Project Management
• 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
• 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
• Functional management and leadership of direct reports within team
• Technical Project management and meeting facilitation
• Frequently communicate status updates across the organization
• Work collaboratively and cross-functionally with various departments
• Personnel Development
• Provide mentorship and guidance to engineers 
• Work with direct reports to establish goals and objectives related to company goals

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Qualifications:

Requirements

• BS in Engineering (biomedical, chemical, or related concentration); MS Degree preferred
• 5+ years in a regulated industry, preferred medical device or pharmaceutical industry in Quality, R&D, or Engineering roles.
• Strong interpersonal and organizational skills; excellent attention to detail
• Preferred knowledge relevant regulations and standards (GMP, ISO, FDA, Medical Device etc.)
• Excellent oral, written, and interpersonal communication skills
• Experience with Root Cause Analysis and Failure Analysis
• Experience in PFMEAs or other Risk Management Systems
• Knowledge of project organization and management tools
• Covid-19 vaccination required, reasonable accommodations as per the ADA are considered.

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

This job requires close contact and potential exposure with biohazardous materials containing blood and human tissue. All employees will be properly trained on the dangers and hazards of the job as well as safety precautions for handling and disposal of wastes.

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How to Apply:

Apply online at https://www.tidesmedical.com/careers/

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