Principal Mechanical Engineer

Actalent - Germantown, MD

Full-time - Senior

Germantown, MD

10,001+ employees

Administrative and Support Services

About the position

The Principal Mechanical Engineer at Actalent is responsible for leading mechanical design and implementation efforts for manufactured systems and manufacturing processes. This role encompasses working on mechanical engineering projects from conception through implementation and fielding. The engineer will focus on process improvement, design optimization, and the implementation of new manufacturing processes and assembly techniques to scale manufacturing efforts effectively. In this position, the engineer will engage in the design and development of tooling and fixtures for manufacturing equipment, ensuring that changes to standard operating procedures are made for replicable equipment and processes within a regulated quality system. A critical aspect of the role involves performing Finite Element Analysis (FEA) to assess the structural integrity and durability of components, systems, and manufacturing tooling/fixtures. The Principal Mechanical Engineer will also lead the design and implementation of manufacturing equipment for device manufacturing at contract manufacturer sites, supporting equipment and process qualifications, including protocol development and execution. The engineer will be responsible for developing and maintaining project timelines, providing updates and feedback to management, and creating production test systems and test plans in accordance with regulatory standards. Additionally, the role requires planning and performing design of experiments to improve and develop new processes through tooling design. Data analysis tasks will also be a part of the job, where the engineer will conduct statistically robust analyses of data and report findings for the development of test method validations for new tools. Support for regulatory submissions and quality compliance for medical device design and manufacturing is also a key responsibility of this position.

Responsibilities

• Lead mechanical design and implementation efforts for manufactured systems and manufacturing processes.
• Work on mechanical engineering projects from conception through implementation and fielding.
• Focus on process improvement, design optimization, and implementation of new manufacturing processes/assembly.
• Design and develop tooling and fixtures for manufacturing equipment.
• Create changes to standard operating procedures for replicable equipment and processes within a regulated quality system.
• Perform Finite Element Analysis to analyze structural integrity and durability for components, systems, and manufacturing tooling/fixtures.
• Lead the design and implementation of manufacturing equipment for device manufacturing at contract manufacturer sites.
• Support equipment/process qualifications including protocol development and execution.
• Develop and maintain project timelines and provide updates and feedback to management.
• Develop production test systems and test plans in accordance with regulatory standards.
• Plan and perform design of experiments for improved and new processes through tooling design.
• Conduct data analysis tasks to perform statistically robust analysis of data and report findings for test method validations for new tools.
• Support activities for regulatory submissions and quality compliance for medical device design/manufacturing.

Requirements

• Mechanical Engineering design experience with Solidworks SW - 3D CAD.
• Experience with Matlab for programming and data analysis.
• Experience with component inventory, SAP, and working with component numbering or logistics.
• 7+ years of experience in a regulated environment.
• Experience in the Medical Device field.
• Minimum Bachelor's Degree in Engineering, with a Master's preferred.