Staff Manufacturing Engineer

Key Role Responsibilities

• Develops process excellence techniques to identify systematic issues. Tracks trends, develops and implements equipment and/or process enhancements that will improve efficiency, product yield, and equipment reliability.
• Leads and executes projects and/or programs of moderate to high level of complexity ensuring safety, regulatory compliance, company standards, operation requirements and business needs.
• Provides technical support to peers and production areas in evaluating process deficiencies, process changes, modifications, and process optimization. Defines, analyzes, reviews, and evaluates problems for prompt solutions.
• Sets the engineering standard and direction for the group and is recognized as the source for mentorship in a field. Reviews evaluations and advice on the selection of suitable equipment for optimized, balanced line performance and makes final recommendations to management.
• Financial management and scheduling – Prepare project estimates for design, equipment, installation, labor, materials, and other related costs. Prepare project forecast, schedules, and tracks costs.
• Challenges the "status quo" on a routine basis and develops new ideas within incoming processes.
• Drive phases of work with different site functions and with other divisions.
• Technical support for Non-conformance issues in the manufacturing area generating investigation reports and corrective action identification (Coordinates and participates on Multi-functional Investigation).
• Follows Standard Operating Procedures (SOP), Good Manufacturing Practices (GMPs), Company Policies and Federal, State and Local Government Regulations.
• Writes, develops, and execute validation strategies.
• Works independently. Plans and develops own methods. Takes actions in the absence of specific instructions. Develops and presents new or improved methods. Solves manufacturing problems in a timely manner.
• Stay in sync with all environmental, safety and occupational health policies.

Qualifications

Required Skills

• Bachelor's Degree in Engineering
• Minimum of 6 years of experience is required in a maintenance manufacturing environment, R&D or Process Development
• Demonstrated experience in Project Management
• Proven experience with validation cycle (FAT, IQ, OQ and PQ)
• Must be fully bilingual: Spanish & English
• Proficiency with Microsoft Office: Word, Excel, PowerPoint

Preferred Skills

• Preferred experience with data analysis tools: Minitab
• Experience working at medical device industry or pharmaceutical preferred

Other

• This position will require up to 10% travel
• The attendance policy for this requisition is Fully Onsite