Address
Form of workResponsibilities:
Qualifications:
- Coordinate and manage new complex process introduction schedule and activities, and cross-product issues throughout the product life cycle.
- Work closely with product engineers and product development engineers during Design Control phases to conceptualize, develop and implement processes. Responsibility includes debugging processes, reliability qualification, cycle time optimization and yield enhancement.
- Validate and document intricate process control systems, testing equipment, and manufacturing equipment using methods such as SPC, process capability, R&R and software test cases to satisfy GMP and FDA requirements.
- Coordinate and lead the identification, development and implementation of new or improved product manufacturing and inspection processes.
- Communicate technical product status to management, including executive level. These can include new or existing processes.
- Support Product Engineering, Product Development, Production, Quality Control, Quality Assurance, and Regulatory Affairs to assure assigned processes successfully produce components or sub-assemblies that conform to applicable drawings, specifications, and/or procedures.
- Maintain and expand in-depth knowledge of pertinent Manufacturing Technologies and disseminate this information as requested to various engineering and production groups.
- Develop, implement and maintain complex PLC controlled processes, including design, PLC programming and development of monitoring methods.
- Stay current with various CAD, programming, inspection, and manufacturing system technologies and philosophies
- Provide various component cycle time estimates for product costing
- Provide cost and return on investment estimates for new equipment
- Perform additional duties that may be assigned by Supervisor
- Support and improve ongoing manufacturing processes
- Develop software or work with IT to develop software systems and databases
- Relate to other people beyond giving and receiving instructions: (a) can get along with co-workers or peers without exhibiting behavioral extremes; (b) perform work activities requiring negotiating, instructing, persuading or speaking with others; and (c) respond appropriately to criticism from a supervisor
- Manage time effectively; prioritize and make good business judgments and decisions in relationship to efficiency
Qualifications:
- Bachelor's of Science in engineering
- At least 5-8 years of Process Engineering experience medical device industry preferred
- Detailed understanding of diagnostic, product test, failure analysis, and debug techniques.
- Proven ability to take complex process designs into production.
- Solid understanding of circuit design, as well as fault modeling and isolation.
- Experienced with CAD software, preferably SolidWorks
- Experience with Visual Basic and CMM programming preferred
- Green Belt in 5S/Lean Manufacturing preferred
- Self-starter with strong leadership, communication skills and proven problem solving ability
- Strong interpersonal and communication skills
- Ability to read, analyze, interpret and follow written instructions
- Ability to interpret and follow oral instructions
- Ability to work in a team environment to achieve a common goal
- Strong computer skills including at minimum, be adept in use of MS Office and Microsoft Outlook
- Demonstrated ability to define problems, collect data, analyze information, establish facts, and draw valid conclusions.
