Sr. Industrial Engineer

Sr. Industrial Engineer

Responsibilities:

• Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors. Demonstrates good judgment in selecting methods and techniques for obtaining solutions. Networks with senior internal and external personnel in own area of expertise.
• Applies the education and experience to develop, maintain and resolve any issues with assigned systems of responsibility. 
• Is familiar with and follows FDA/ISO Design Control principles and regulations in product development.
• Act as a Project Leader for major projects assigned (concept through release).
• Develops and establishes detailed Design (engineering) input specifications to ensure product function, minimized patient risk and cost effective manufacturing.
• Develops and maintains the documentation necessary to ensure the consistent manufacture of products (processes, drawings, and shop floor paperwork).
• Influence design for assembly accessibility and fabrication of all materials including plastic injection molding, machining, welding, etc…
• Provides engineering support for troubleshooting efforts for any process issues in designated area. Summarizes and draws conclusions from test results leading to effective technical resolution of process problems.
• Focus on planning and executing the transfer of products from design-to-production in a proactive and highly-collaborative manner
• Ensures design for manufacturing elements are incorporated into new product development activities.
• Identifies, justifies, and implements multiple significant data driven projects to reduce manufacturing costs, improve processes, increase product reliability, and enhance process capability.
• Designs and evaluates new and existing fixtures and equipment, test methods, specifications, layouts, and standards.
• Identifies and recommends manufacturing technologies to strategically develop business objectives and potential opportunities.
• Interfaces regularly with vendors/consultants based on responsibilities and assignments.
• Collaborates with manufacturing staff and management in other disciplines to develop, evaluate, and improve manufacturing methods.
• Conducts in-depth research to develop and introduce improved manufacturing methods. Analyzes assembly processes to ensure quality results are achieved and sustained. Analyzes data to determine return on investment.
• Works with production personnel, suppliers and contract manufacturers to establish or revise work instructions and production procedures.
• Ensures quality outcomes in device manufacturing areas by working with suppliers, quality systems, procurement and sustaining engineering.
• Performs hazard analysis on new equipment and systems to insure safe working conditions.
• Establishes validation protocols related to assembly and test processes.
• Design impact on Cost of Production (COP) reduction and recommend cost-saving measures
• May escalate issues to supervisor/manager for resolution, as deemed necessary.
• Provide mentoring and assistance to Engineer II and I level staff.

Qualifications:

• Bachelor’s Degree in related engineering or scientific discipline required; Advanced Degree desirable
• Bilingual English/ Spanish (Excellent English communication skills) German skills desirable
• 5 – 8 years’ related experience; or a Master’s degree with 3 years’ experience; or a PhD with 1-year experience; or equivalent directly related work experience.
• Related experience in medical device preferred.
• Related experience in design for manufacturability and extensive experience with CAD software.
• Test protocol generation, execution, and reporting.
• Knowledge of current statistical and analytical methods.
• Knowledge of manufacturing documentation.
• Knowledge of design control and product development cycle
• Experience with design and process FMEA, Process Validation and variability reduction applications.
• Implementation and support of Advanced Manufacturing, Lean Manufacturing, Demand Flow, Total Quality tools.
• Application of statistical and analytical methods such as SPC, SQC, and DOE.
• Development and qualification of tooling/equipment (IQ/OQ/PQ, support, design).
• Independent design creation of parts and assemblies taking into account the requirements.
• Independently detail design, create CAD models and technical drawings, and describe design output and create component design documents.
• Independent coordination to achieve DFM (Design for Manufacturing) and DFA (Design for Assembly)
• Excellent interpersonal, verbal and written communication skills.
• U.S.A Visa required.