Senior Process Engineer

About This Role

This role involves independently conducting development work on complex research and development projects, focusing on new or improved techniques and procedures in medical device manufacturing. The Senior Process Engineer will drive the development of novel medical devices and sub-assemblies, providing technical guidance and contributing to intellectual property.

Responsibilities

• Drive complex or novel assignments requiring the development of new or improved techniques and procedures
• Complete engineering work in technology development, product design, material testing, specification preparation, process study, research investigation, and report preparation
• Provide guidance to product and technology teams
• Assess the feasibility and soundness of alternative engineering processes, products, or equipment
• Coordinate, manage, and document project goals and progress, recommending appropriate revisions
• Develop and coach others on engineering documentation
• Train and/or provide work direction to technicians and less experienced engineers
• Lead engineering teams to the successful completion of project goals
• Demonstrate PDP/TPD system knowledge through coaching and delivery of high quality, high impact deliverables
• Lead test method development for conditioned testing on novel medical devices and sub-assemblies

Requirements

• Strong understanding of test method development processes and design including documentation and training
• Experience with sterilization and aging protocols for medical devices
• Test Method Process methodologies experience
• Experience working through medical device quality systems

Qualifications

• 8-13 years with BS, 6-11 years with MS, 4-8 years with PhD

Benefits