We are seeking an Advanced Manufacturing Engineer with automation experience to support the bring-up of a new medical device packaging assembly facility. This position requires an experienced professional with a track record of developing manufacturing processes from clean slate.
The successful candidate will have spent considerable time launching new manufacturing facilities and/or new products in a regulated manufacturing environment.
- Act as a subject matter expert (SME) for Automation-related topics.
- Participate and represent manufacturing operations in facilities planning, quality system planning and implementation, and integration meetings involving other stakeholders.
- Establish equipment requirements, coordinate and manage automation vendor deliverables and build schedule, including factory acceptance testing (FAT), site acceptance testing (SAT), equipment commissioning, routine preventive maintenance, service and repair arrangement.
- Perform design review with automation vendor to ensure design for manufacturability and maximized end-user experience.
- Collaborate with Sourcing, Product, and Supply Chain teams on product packaging and labeling requirements for automation.
- Lead discussion with component suppliers to improve packaging design and quality for optimal and sustainable automation efficiency.
- Create and maintain automation system and associated documentation, including automation specification documents and SOPs.
- Provide training to technicians and operators.
- Develop, review, and execute automation qualification and validation protocols and reports per FDA requirements.
- Familiar with selection and implementation of MES (Manufacturing Execution System), knowledge of computer system validation (CSV) requirements is desirable.
- Lead failure investigation and support internal CAPAs related to equipment and process nonconformances.
- Lead continuous improvement activities to optimize automation, reduce downtime, and improve process yields.
- Maintain a work environment in adherence to FDA cGMP and ISO13485 requirements.
- Up to 15% of domestic and international travel may be required
- B.S. in Mechanical, Electrical, or Manufacturing/Industrial Engineering, 5+ years of manufacturing operation experience, working knowledge of the automated packaging assembly and order fulfillment, or an equivalent combination of education or experience
- Hands-on experience in a regulated high volume manufacturing environment (concept through high-volume production), preferably medical device
- Proficient knowledge of automation systems - PLC, HMI, vision, robotics, MES, MRP, ERP, etc.
- Corrugated packaging assembly process experience is a plus
- Detail-oriented, with excellent written and verbal communication skills
- Strong technical writing and presentation skills
- Ability to be flexible and manage change
- Ability to work independently and collaboratively
- Experience with process validation for regulated industry, medical device experience strongly preferred
- Passion for finding new, innovative, non-traditional methods for accomplishing goals
- Flexibility to adapt to changing work environments, new priorities, new instructions, delays, or unexpected events
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