The Sr. Manufacturing Engineer plans, directs and coordinates manufacturing processes for medical device products and supports Operations to assure a quality product is produced in a timely manner. Works with multiple departments such as Lean, Leadership, Operations, Quality Assurance, R&D, Procurement, and Regulatory Affairs to improve existing product designs and processes to increase throughput, decrease operational costs, and improve quality.
PRIMARY DUTIES AND RESPONSIBILITIES:
- Provide improvement and sustaining engineering support for existing production lines.
- Develop, maintain, and improve manufacturing and inspection processes and procedures.
- Support and/or perform equipment, process validations and testing to internal procedures.
- Provide process development engineering support for new product development.
- Initiate equipment modifications to improve productivity and product quality.
- Work with outside vendors to coordinate the development of manufacturing equipment.
- Work closely with maintenance department to improve machine reliability, reduce downtime, and define equipment maintenance requirements.
- Assist with procurement
- Assist with resolving issues with suppliers.
- Assist with repairing equipment and tooling.
- Assist with performing process failure mode effects analyses.
- Work with Operations and outside vendors to create methods/process to improve production capacities.
- Document Cost Savings
- Work with management to establish project timeliness, project justification, and budget forecasts.
- Act as resource for operational departments for materials, equipment and process upgrades.
- Must demonstrate responsibility for the quality and financial aspects of the company.
- Pursue and participate in company LEAN initiatives.
- Bachelor's degree (B.S.) in Mechanical or Manufacturing Engineering from a four-year college or university.
- Minimum 5 years of experience working in a manufacturing environment.
- Minimum 5 years of experience with Solid Works.
- Experience in Lean Manufacturing
- Experience working in manufacturing for medical devices
- Exposure to CNC, molding, and grinding equipment
- CNC programming and troubleshooting
- PLC programming and troubleshooting
- Experienced in the design, development and assembly of fixtures, automation workstations for manufacturing
- Effective interpersonal communication skills and able to interface with cross functional teams
- Strong technical writing skills; able to explain technical terminology in layman's terms to Product Development groups, peers and senior management
- Possess critical thinking skills and able to be assertive, & challenge the process in a diplomatic manner
- Knowledge of statistical techniques like Gage R&R Studies, Design of Experiments, Failure Mode and Effects Analysis
- Working knowledge of Microsoft Office (Word, Excel, Access, and PowerPoint)