The Project Engineer employs both technical and project management skills to engineer state of the art process and assembly technologies that enable new product development efforts for next generation personal drug delivery devices. As a team member of the Advanced Engineering Group this engineer will execute assignments and own areas of projects for product and process development, product design for manufacturability, machine automation, tooling design, and/or supplier selection and development. As required, the Project Engineer generates documentation in accordance with applicable company practices and FDA, ISO, GMP, and QMS regulations.
location: Scottsdale, Arizona
job type: Permanent
work hours: 9 to 5
- Partner with internal and external team resources to execute assignments in any of the following project areas:
- Product/Process Development - Identify customer, design, and manufacturing requirements to drive engineering activities related to DfX, manufacturing process selection, feasibility testing, equipment/tooling design and procurement, test method development, process characterization & validation, manufacturing work instructions, and/or operator training.
- Process Automation - Provide engineering and project support for developing semi and fully-automated process equipment. Generate project-driving documentation, facilitate procurement, and enable successful equipment installation and qualification activities.
- Supplier Selection/Development - As directed, find and engage suppliers for assigned projects requiring procurement of materials and/or services. Communicate requirements and perform supplier evaluation according to pre-determined protocols and standard practices. Provide incoming receiving inspection with needed tooling and equipment to ensure acceptability.
- Project Management - maintain scope and timeline documentation for communicating knowledge and status of project assignments. Contribute this information to Program Management Organization for overall program management.
- Customer Engagement - As required, support technology program initiatives with customer interaction to understand requirements and/or communicate status.
- Ensure technical and customer requirements for assigned projects are achieved.
- Ensure that all required documentation deliverables are satisfied and delivered.
- Develop and maintain required quality records and project management documents associated with assigned projects.
- Follow applicable product development and project management processes & methods.
- Maintain clear communication paths with stakeholders.
- Conduct routine project reviews with Project Teams and Management.
- Interface with customers and external support services, e.g. suppliers and contract vendors, to facilitate the development and execution of assigned projects.
- BS in Engineering, Materials, Chemistry, or equivalent technical degree.
- Minimum 3 years of experience working as an engineer in medical device, pharmaceutical, or similarly regulated industry.
- Demonstrated ability to:
- Prioritize and complete multiple technical projects and daily tasks
- Learn and apply new skills
- Understand and communicate technical ideas with technical and non-technical audiences (written and verbal)
- Translate ambiguous customer needs into defined requirements
- Proficient with Microsoft Office Suite software, and project management software such as Microsoft Projects.
- 3-5 years of experience in medical device product and manufacturing process development
- Familiarity with process automation (vision systems, robotics, controls, or electronics)
- Working knowledge of applicable federal and international regulations (i.e. 21CFR Parts 210, 211, and 820).
- Working knowledge of 3D design applications preferred.
skills: Process Engineering
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.