Engineer II, AME

Position Summary    Conducts process validation activities related to design transfer and manufacturing improvement projects. Supports strategic initiatives such as CAPAs, remediations, and continuous improvement. Collects BOMs, drawings, and work instructions from Agile for product transfers, including translations.

Essential Duties & Responsibilities
Works with the Advanced Manufacturing Engineering team to understand and localize production processes and test requirements.
Supports sample builds and the development of local Work Instructions.
Supports and/or owns Design Verification and Process Validation build preparation for New Product Introduction (NPI) projects, or as part of CAPA investigations and corrective actions.
Validates development tools of moderate complexity and compiles metrics and engineering data, including validation testing outputs.
Supports verification and validation protocols issued under NPI projects.
Supports and/or leads process validation activities per Master Validation Plans (IQ, Process Characterization, TMVs, CSV, OQ, and PQ), as well as BOM creation, manufacturing procedures, and product unit cost definition.
Troubleshoots production line issues, including performing root cause analysis for product, equipment, and system failures.
Collaborates with internal departments, vendors, and equipment suppliers to resolve issues and coordinate efforts in support of business objectives.
Ensures safety procedures are followed and leads by example.
Performs various industrial engineering technical tasks of intermediate scope and complexity, under limited supervision from the direct supervisor or engineering staff.
Knowledge & Skills

Good analytical , problem solving and project management skills
Ability to work in a geographically diverse business environment
Ability to leverage and/or engage others to accomplish projects
Good verbal and written communications with ability to effectively communicate at multiple levels in the organization
Multitasks, prioritizes and respects deadlines.

- Good organizational and follow-up skills, as well as attention to detail
Site best practices (routings, manufacturing layouts, validations)

Minimum Qualifications , Education & Experience
Bachelor’s engineering degree from an accredited college or university is required.
3-5 Years of experience similar role in medical device industry.
Demonstrated experience with lean principles
Advanced English communication skills