Mfg. engrs - Manufacturing Engineer
On-siteIndianapolis, Indiana, United States
Job Summary
Adhere to Viant Core Beliefs, FDA regulations, and quality management systems while creating lean processes for cellular manufacturing involving CNC Milling, Laser Cutting, and Assembly. Define standard work instructions, develop tooling and fixtures to optimize productivity, and execute root cause analysis for NCRs and CAPAs. Drive process improvements and cost-savings projects through data-driven decision-making, manage change records, and collaborate with programmers and suppliers to evaluate designs for manufacturability. Lead cross-functional teams to implement creative solutions and ensure internal and external customer expectations are met. Apply engineering principles to improve Quality, Delivery, Cost, Safety, and Morale in medical device manufacturing.
Required Qualifications
- Adheres to Viant Core Beliefs and all safety and quality requirements including, but not limited to: Quality Management Systems (QMS), Environmental Management Systems (EMS), U.S. Food and Drug Administration (FDA) regulations, company policies and operating procedures, and other regulatory requirements.
- Creates and implements lean processes in a cellular environment utilizing appropriate methods such as CNC Milling, CNC Punch, Punch Press, Waterjet, Laser Cutting, Laser Etch, Wire EDM, Deburr, Mass Finishing, Cleaning, Assembly, and Inspection.
- Defines, produces and implements documents including standard work and process work instructions.
- Investigates, develops and implements new process technologies.
- Successfully communicates complex issues with customers and internal team members.
- Leads NCR investigation, root cause analysis and corrective & preventative actions.
- Creates, reviews and approves engineering drawings; initiates and drives the Change Record process.
- Creates and evaluates manufacturing operations to maintain accurate standard rates.
- Identifies and drives process improvements and cost-savings projects through root cause analysis and data driven decision-making.
- Develop and complete manufacturing documentation (pFMEA, control plan, process flow, work instructions, and inspection plans).
- Develops tooling, fixtures and equipment to optimize productivity and cost.
- Effectively owns and manages CAPAs pertaining to their areas of responsibility.
- Collaborates with programmers, operators and suppliers to evaluate designs for manufacturability and cost reduction.
- Plan and execute projects on time and within budget to achieve tangible results.
- Participates in cross-functional project teams to implement creative solutions.
- Ensure internal Viant and external customer expectations are met or exceeded.
- Candidate shall have at least one of the following: 1) Engineering or Bachelor's degree in a technical field with applicable experience, 2) 20 plus years of applicable experience, or 3) Associate's degree with 15 plus years of applicable experience.
- 3 – 7 years of applicable engineering experience
- Strong problem-solving skills.
- Ability to provide solid rational and justification for process improvement change requests
- 2D and 3D drawing experience required.
- Ability to work in a team environment.
- Strong written and oral communication skills.
- Light work: Exerting up to 20 pounds of force occasionally, and/or up to 10 pounds of force frequently, and/or lift, carry, push, pull, or move objects.
- Limited travel may be required
- Position location: 100% On-site, Indianapolis, Indiana
Desired Qualifications
- Lean manufacturing and new product development or launch support experience is highly desirable.
- Understanding of sheet metal manufacturing preferred.
- Experience in medical device is preferred.
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