Job Description

SUMMARY: Plans and coordinates work to higher level project schedules; develops longer term plans under guidance; analyzes complex problems independently, coordinates cross-functional development and supplier work. Responsible for creating, documenting, developing and implementing procedures used to assemble, process, test and /or manufacture products. Will design, implement, monitor and maintain manufacturing processes. Consult with design engineers in order to achieve the most efficient and cost effective way of producing the highest quality product possible.

ESSENTIAL FUNCTIONS: The incumbent may be required to perform all or a combination of the following essential functions as determined by business necessity.
 

• Perform and report on evaluation testing, verification and validation in accordance with ISO, FDA and corporate guidelines.
• Estimate production times, staffing requirements, and related costs to provide information for management decisions.
• Confers with management and other staff regarding manufacturing capabilities, production schedules and other considerations to facilitate production processes.
• Apply statistical methods to trouble shoot processes and conduct root cause analysis.
• Improve existing operations, incorporating new methods, processes and training.
• Handle equipment purchase and installation, perform IQ/OQ and PQ functions.
• Investigate operational problems affecting production and deal with them in a systematic, methodical manner.
• Prepare manufacturing documentation required for product manufacture.
• Coordinate projects.
• Identify ways to reduce production costs.
• Work with R&D and other departments to produce cost estimates for new designs.
• Work with regulatory bodies to ensure safety, environmental and design standards are met.
• Serve as a team member in support of ‘design for manufacturability’.
• Assist R&D in the transition of new products to production product status.
• Generate and update assembly documentation (travelers/work instructions).
• Process engineering changes (ECOs)
• Control manufacturing costs by employing creative manufacturing and assembly methods (fixture design).
• Determine and review product cost.
• Provide production floor support.
   

NON-ESSENTIAL FUNCTIONS: In addition to the essential functions listed above, the incumbent may be required to perform other non-essential functions. Employees are required to follow any other job-related instructions and to perform any other job related duties requested by their supervisor.

QUALIFICATIONS:
 

• BS in mechanical or manufacturing engineering. Strong background in interpretation of Engineering drawings/specifications and manufacturing process planning/evaluation.
• Prior experience in machine shop practices including milling, turning and grinding a plus.
• Experience with Six Sigma.
• Previous experience with automation a plus.
• Experience with mechanical design using SolidWorks.
• Minimum of 7 years of related experience – preferably in the medical device industry.
• Excellent written and verbal communication skills. Prior experience in technical writing and procedure development.
• Must have demonstrated ability to work as part of a team.
• Strong analytical and problem solving skills.
• Must be self-motivated.