POSITION SUMMARY:
The Manufacturing Engineer III participates in R&D, Operations, and Engineering initiatives. Directly responsible for leading the metals fabrication Processes include robotic assembly , welding, laser marking, polishing, passivation and packaging of small complex medical devices. This position will be working closely with external technology partners in new manufacturing and automation processes for manufacturing Medical Devices.
PRIMARY RESPONSIBILITIES:
This position will lead efforts to develop manufacturing processes in a high mix low volume environment. . Specific responsibilities will include:
: Determine optimal production process to meet unit volume requirements and finished product specifications
: Identify and work with suppliers and/or consultants to develop manufacturing processes and determine equipment requirements
: Run trials to confirm efficacy of selected processes. Develop analysis to support process selection.
: Design and or Select, purchase and install equipment that will reliably and repeatedly meet finished product specifications.
: Develop processes that will reliably and repeatedly meet finished product specifications.
: Perform analysis to determine space, utilities and human resource requirement to meet unit volume requirements
: Using Lean concepts develop production layout for efficient process flow.
: Create process documentation that satisfies GMP requirements.
: Work with Quality and Regulatory to ensure ISO 13485 and GMP compliance.
: Perform process validations to certify repeatability of selected processes.
: Solve manufacturing problems.
: Develop job descriptions and train operators on new processes. Develop training programs and material.
: Develop detailed project plans identifying key resources requirements and project risks along with mitigation options.
: Present manufacturing analysis and plan to senior management along with recommended actions.
: Directly manage project team to achieve completion of project objectives and milestones as per project documentation.
: Communicate project progress and alert stakeholders when key milestones will not be achieved.
REQUIRED KNOWLEDGE, SKILLS, and ABILITIES:
: 10 years of experience in a manufacturing environment.
: 3 to 5 years of experience in medical device manufacturing environment.
: 3 to 5 years of intelligent automation design experience.
: 3 to 5 years project management experience.
: Knowledge of Orthodontic bracket manufacturing is a heavy plus.
: Knowledge of welding, brazing, laser marking and polishing of metals
: Knowledge of ceramics a plus
: Experience working in a high mix low volume environment
: Strong communication skills, written & verbal
: Solid team building skills
: Lean manufacturing and advanced statistical analysis.
: Computer literacy, knowledge of Microsoft Windows, Solidworks, Minitab and Microsoft Office tools.
: Understanding of Bill of Material (BOM).
: Capable of creating drawings, manuals, and engineering specifications.
: Self-starter with enthusiasm and ability to work in a team environment.
: Familiarity with ISO standards, GMP, and OSHA regulations.
: Process Validations and Risk Analysis FMEA / DFMEA.
EDUCATIONAL QUALIFICATIONS:
: Minimum of BS degree in Engineering discipline.
ENVIRONMENTAL REQUIREMENTS:
: Primarily an office environment; must be able to use all office equipment (PC, phone, fax, copier, etc)
: Limited temperature fluctuations, air conditioned environment
: Frequently in manufacturing environment for extended period of time.
PHYSICAL REQUIREMENTS:
: Must be able to sit for long periods of time
: Must be able and willing to travel via car or plane to designated areas
: Must be able to stand for at least 4 hours at a time
: Must be able to transport, lift, and demonstrate equipment weighing up to 40 lbs.
Search Solution Group - 9 months ago
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