Senior Manufacturing Engineer represents the Operations department on projects to support transfer of designs from R&D into Manufacturing. The individual will be a key member of cross-functional teams, performing activities associated with process development and design transfer. The individual will be responsible for presenting technical updates to the team, supporting the development team in areas such as Design for Manufacturability, process control/characterization, manufacturing documentation, and providing production support during engineering builds. Additionally, the individual will support manufacturing activities both internally and with contract manufacturers.

PRINCIPAL DUTIES AND RESPONSIBILITIES

• Design experiments, develop protocols, perform process validations and data analysis, draw conclusions, and communicate results.
• Troubleshoot/improve manufacturing processes.
• Design/select equipment & fixtures and qualify them for manufacturing.
• Establish process flow and production line layouts.
• Train assemblers, technicians, and engineers on new processes. Provide line support for internal manufacturing. Release and revise manufacturing documents.
• Qualify suppliers and contract manufacturers (CMs) to fabricate components, subassemblies. Travel (domestic) to support suppliers and CMs. Provide on-going technical support for suppliers and CMs.
• Support Quality technicians with incoming inspection of components and subassemblies.
• Design and maintain product label templates.
• Work with suppliers and consultants to develop product packaging.

EXPERIENCE REQUIREMENTS

• Minimum of 5 years of experience in a medical device manufacturing environment.
• Experience preferred with the following: vertical laminator; Minitab; BarTender, QAD.

EDUCATION REQUIREMENTS

• Bachelor’s degree in Mechanical, Materials, Manufacturing, or related engineering field.

OTHER QUALIFICATIONS

• Strong written and verbal communication skills
• Hands-on skills for training, process development, and troubleshooting.
• Attention to detail in process characterization and documentation.
• Ability to use Solidworks to design fixtures and to modify components & assemblies.
• Ability to design and execute experiments to characterize and improve processes.

Seniority level

Mid-Senior level

Employment type

Full-time

Job function

Engineering, Manufacturing, and Production

Industries

Medical Equipment Manufacturing, Biotechnology Research, and Hospitals and Health Care