Manufacturing Engineer

Role: Manufacturing Engineer

Responsibilities:

• Design and develop manufacturing processes, tooling, and fixtures to meet production schedules while enhancing productivity and product quality.
• Evaluate and manage production equipment.
• Provide production support and perform process validations.
• Interface with vendors for incoming components and materials.
• Troubleshoot manufacturing processes and equipment issues.
• Utilize tools such as Gage R&R, Cp, Cpk, and SPC to improve processes.
• Analyze data using basic statistical methods and electronic data collection systems.
• Apply manufacturing concepts such as Value Stream Mapping, 5S, and Visual Workplace to improve quality, labor efficiency, and throughput.
• Write and update protocols, reports, and manufacturing process documentation.
• Collaborate with cross-functional teams to develop and implement process improvements.
• Identify root causes of issues and implement corrective actions to prevent recurrence.
• Support quality and regulatory initiatives, including Quality Management Systems (QMS) and Environmental Management Systems (EMS).
• Ensure compliance with FDA regulations, regulatory requirements, policies, procedures, and processes.
• Maintain positive and cooperative communication and collaboration across all levels of the organization.
• Perform other related duties and responsibilities as assigned.

Qualifications:

• Bachelor’s degree in Electrical, Mechanical, Chemical, Biomedical, or Manufacturing Engineering, or equivalent experience.
• 3-5 years of relevant engineering experience with semiconductor, MEMS, or medical device manufacturing processes, including cleanroom environments.
• Knowledge of solvent and acid cleans, wet and dry etch processes, PVD, sputtering metal deposition, wire-bonding equipment, and processes.
• Experience with wafer alignment and bonding, laser cutting, and various test and measurement equipment.
• Strong computer skills, including proficiency in Microsoft Word and Excel.
• Hands-on experience with SolidWorks, Minitab, and CAD systems.
• Excellent skills in wafer and individual device handling.
• Ability to work in a matrixed and geographically diverse environment.
• Effective in both individual and team settings in a fast-paced, dynamic environment.
• Strong verbal and written communication skills, with the ability to interact at multiple organizational levels.
• Multitasking and prioritization skills with the ability to meet deadlines.
• Strong organizational skills, attention to detail, and follow-up capabilities.
• Willingness to travel up to 5%, including internationally.