Manufacturing Process Engineer-Medical Device

Job Description

Job Summary:

The Manufacturing Engineer will support production operations by leading and executing technical engineering activities within a regulated manufacturing environment. This role focuses on equipment qualification, process validation, and line capacity expansion. The position requires strong problem-solving skills, hands-on engineering experience, and the ability to work both independently and collaboratively in a cleanroom setting.

Key Responsibilities:

• Lead and execute manufacturing engineering activities related to line capacity expansion initiatives

• Perform equipment qualification and ensure compliance with established validation standards

• Develop, implement, and support process validation activities

• Identify technical issues proactively and recommend effective solutions using engineering judgment

• Collaborate with cross-functional teams to support manufacturing operations and project goals

• Review and validate engineering approaches through peer discussions and technical assessments

• Support continuous improvement initiatives within manufacturing processes

• Maintain accurate documentation for validation, qualification, and engineering activities

• Work in a cleanroom environment following gowning and compliance requirements

Required Qualifications:

• Bachelor’s degree in Electrical, Mechanical, Software Engineering, or related engineering field

• Minimum 2–5 years of experience in manufacturing engineering or related discipline

• Experience with equipment qualification and process validation

• Strong understanding of manufacturing operations and engineering principles

• Ability to solve complex technical problems and apply innovative solutions

• Experience working in regulated or controlled environments

Preferred Qualifications:

• Experience supporting line capacity expansion projects

• Familiarity with cleanroom manufacturing environments

• Knowledge of validation documentation and compliance practices

• Strong communication and collaboration skills

Benefits:

The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long-term disability insurance, short-term disability insurance, paid parking/public transportation, paid time off, paid sick and safe time, hours of paid vacation time, weeks of paid parental leave, and paid holidays annually – as applicable.

Pay Range: $30/hr to $35/hr