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.
COMPENSATION: $101,000-$145,000