14 Aug
Staff Operations Engineer
Vacancy expired!
- Optimize manufacturing processes and productivity leveraging production data.
- Ensure effective product life cycle management
- Daily Engineering support/communication/coordination of instrument production and metrics
- Read, write, train, and interpret instructions/specifications for electromechanical, high tech medical device including safety precautions
- Creation and use of process engineering data and statistics to evaluate/improve processes.
- Develop, maintain, and process changes to manufacturing procedures, maintenance instructions, and specifications used in manufacturing.
- Identify, Lead and implement projects to reduce cost and supply chain risk, improve quality and instrument reliability.
- Establish and lead governance, SOPs, program management and KPI including root cause investigation and correction.
- Execute CAPA resolutions in manufacturing including at OEM
- Lead process FMEA to optimize efficiency and flow of laser manufacturing lines
- Leverage tools like 5 whys, fishbone, FMEA, etc for risk mitigation and corrective action
- Develop Gannt charts and Visio process flows to effectively manage projects
- Drive manufacturing quality and 5S
- Facilitate design for manufacturability/assembly/test and seamless execution of new product/process/equipment introductions at OEM, contract manufacturer and in-house
- Provide thorough engineering solutions aligned with business needs leveraging process mapping
- Serve as ops engineering lead to facilitate effective introduction of new products to manufacturing
- Represent Supply Chain Operations on cross-functional initiatives.
- Develop and execute validation plans for process and design changes.
- Develop and execute test plans/ root cause troubleshooting analysis at product and process levels.
- Develop measurements and goals aligned with the business; monitor performance to identify support needs in addressing performance gaps in plant yields, OEE, machine/personnel utilization and process controls.
- Drive analysis and continuous improvement of material use (yield performance).
- Review analysis of equipment time use (OEE), identifies areas of opportunity and guides continuous improvement.
- Develop innovative solutions to problems and present status to executive team
- Provide development support and guidance on process control systems to optimize process performance and functionality for the operator.
- Work cooperatively with Sustaining Engineering to develop project scopes and process engineering packages for improvement programs.
- Create and implement significant cost savings annually via continuous improvement programs
- Enhance 6S and other lean principles by empowering/training the workforce
- Prepare and maintain the detailed layouts, and designs for manufacturing floor and fixtures
- Embody and deliver the "Exceptional Everyday"
- Specific Area of Study: BSEE, BSME or BSIE, biomedical engineering
- Specific Related Experience: Instrument manufacturing engineering experience or equivalent, preferably medical device or other regulated industry. Produce related experience within manufacturing operations preferred, including an increasing level of responsibility.
- Strong project management experience and Lean/Continuous improvement experience
- SAP/PLM experience beneficial
- Excellent soft skills - interpersonal savvy, listening, organizing, planning, time management, Learning on the fly, execution, focus, approachability, independence and good judgment, positive attitude
- High energy
- Hands on Mechanical/Electrical Engineering skills critical.
- Software and optics knowledge beneficial
- Communication-must be able to effectively communicate in both written and verbal forms, and at all levels in the organization
- Familiarity with various advanced manufacturing process technologies
- Demonstrated proficiency in time and project management
- Teamwork - must be able to work effectively with fellow colleagues
- Experience managing OEM and contract manufacturers in addition to in-house manufacturing
- Failure Mode Effect Analysis, statistical process control, CAPA experience
- Experience with regulatory, ISO and FDA with electromechanical medical devices extremely beneficial
- Advanced portfolio management
- Strong skills working across global cultures.
- Detail oriented with strong organization and time management skills to meet deadlines in a rapidly changing environment
Vacancy expired!