The Manufacturing Engineer is a non-supervisory individual contributor reporting to a Senior Manufacturing Engineer and supporting assembly and production lines across mixed medical device processes. This role is responsible for maintaining safe, compliant, efficient engineering practices while supporting production, driving process improvements, and delivering projects in a medical device manufacturing environment.
Responsibilities
- Provide timely support for day-to-day issues on assembly and production lines.
- Lead production line optimization, equipment implementation, corrective and preventive actions, and new product introduction projects.
- Drive process improvements using root cause analysis and Lean manufacturing principles.
- Develop and maintain work instructions and manufacturing documentation using quality management systems and spreadsheet-based tools.
- Plan and execute process validation activities in accordance with company policies, procedures, and customer requirements.
- Recommend and implement measures to improve productivity, product quality, and employee safety.
- Scope, organize, and deliver projects according to committed timelines.
- Maintain compliance with applicable FDA and ISO requirements.
- Communicate project status and ongoing activities to senior engineering, quality personnel, and cross-functional partners.
- Evaluate situations independently, make fact-based decisions, and perform duties with minimal supervision.
- Maintain cooperative working relationships, professional conduct, confidentiality, and a positive attitude.
- Perform other duties as assigned by the Senior Manufacturing Engineer.
Required Qualifications
- Bachelor’s degree in Engineering or a related field, or equivalent experience.
- At least 3 years of experience in manufacturing engineering.
- Experience in medical manufacturing or a similar industry.
- Valid driver’s license.
Preferred Qualifications
- Experience with Lean manufacturing and root cause analysis.
- Experience with process validation.
- Experience with CAD or SolidWorks.
- Knowledge of FDA regulations and ISO 13485.
- Experience preparing technical documentation.
- Experience collaborating cross-functionally.
CMM is a premier full service contract manufacturer. We specialize in mechanical and electrical/mechanical assembly of class 1 and class 2 sterile and non sterile devices. In addition to assembly work we also offer our partners a single source partner for purchasing, incoming inspection, warehousing, device testing , packaging, labeling and where needed management of the sterilization process through third party sterilization facilities.
