Responsibilities
- Lead and execute cost reduction and continuous improvement initiatives.
- Act as primary technical point of contact for engineering projects and oversee project execution.
- Propose practical ideas aimed at reducing manufacturing costs and enhancing process efficiency.
- Write, review, and revise assembly and test procedures in collaboration with end users.
- Establish and manage documentation for production, testing, and inspection workflows.
- Design, build, and qualify equipment used in manufacturing and testing operations.
- Collaborate with plant and division teams to assess and roll out product and process changes.
- Provide regular updates on change implementation status to stakeholders and management.
- Maintain accurate specifications and work instructions for manufacturing and quality processes.
- Design and refine production methods to enhance workflow, reduce variation, increase capability, and ensure workplace safety.
- Develop and revise process failure mode and effects analyses (PFMEA) and risk assessments.
- Determine when manufacturing systems or processes require validation to meet regulatory and quality standards.
- Manage validation activities including installation, operational, and performance qualification (IQ/OQ/PQ).
- Stay current with internal policies, ISO standards, and FDA regulations affecting manufacturing operations.
- Acknowledge that job duties may evolve over time with or without notice to meet business needs.
Work Arrangement
On-site
Other
- Standard work schedule is Monday through Friday, 8 AM to 4 PM.
- Flexibility may be required to align with off-shift teams and cross-functional partners.
- Travel within and outside the United States may be necessary for project coordination.
- Must adhere to all relevant quality and compliance regulations as defined by the organization.
- Employment may require proof of full vaccination against COVID-19, depending on role.
- Requests for reasonable accommodation will be reviewed in accordance with applicable laws.
- Work shift listed as US BD 1st Shift: 8am-5pm (United States)
