Job Number: 32770
Job Summary: The incumbent in this role plans and coordinates work according to higher-level project schedules. They develop long-term plans, analyze complex problems, and coordinate cross-functional development and supplier work. Their main responsibility is to create, document, develop, and implement procedures for assembling, processing, testing, and manufacturing products. They also design, implement, monitor, and maintain manufacturing processes, working with design engineers to ensure efficient and cost-effective production of high-quality products.
- Perform and report on evaluation testing, verification, and validation in compliance with ISO, FDA, and corporate guidelines.
- Estimate production times, staffing requirements, and related costs to provide information for management decisions.
- Consult with management and other staff to facilitate production processes, considering manufacturing capabilities and production schedules.
- Apply statistical methods for troubleshooting processes and conducting root cause analysis.
- Improve existing operations by incorporating new methods, processes, and training.
- Handle equipment purchase and installation, performing IQ/OQ (Installation Qualification/Operational Qualification) and PQ (Performance Qualification) functions.
- Investigate operational problems affecting production and resolve them systematically and methodically.
- Prepare manufacturing documentation required for product manufacture.
- Coordinate projects.
- Identify ways to reduce production costs.
- Collaborate with R&D and other departments to estimate costs for new designs.
- Ensure compliance with safety, environmental, and design standards by working with regulatory bodies.
- Contribute to the "design for manufacturability" process as a team member.
- Assist R&D in transitioning new products to production status.
- Generate and update assembly documentation (travelers/work instructions).
- Process engineering changes (ECOs).
- Control manufacturing costs through creative manufacturing and assembly methods, including fixture design.
- Determine and review product costs.
- Provide production floor support.
- Bachelor's degree in mechanical or manufacturing engineering, with a strong background in interpreting engineering drawings/specifications and manufacturing process planning/evaluation.
- Prior experience in machine shop practices, including milling, turning, and grinding, is a plus.
- Experience with Six Sigma.
- Previous experience with automation is 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, with 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.