Senior Manufacturing Engineer - Spectrum Staffing Services/HRStaffers Inc.

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 to achieve the most efficient and cost-effective way of producing the highest quality product possible.

RESPONSIBILITIES

• 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.

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.