This role supports base business improvement and/or new product launches, develops tooling and fixtures, implements lean methodology, investigates issues using root cause analysis, implements improvements, manages CAPAs, and creates documentation such as standard work and validation protocols. Additionally, they will lead quoting efforts for new business opportunities by reviewing prints, determining efficient processes for manufacturing, identifying part and project risks, proposing DFM, and generating pricing through use of quote tools. They will be responsible for completion of quotes and will be a critical person to provide technical feedback. This position will collaborate cross-functionally to optimize designs for manufacturability, cost, and communicate effectively with internal teams and customers.
Responsibilities:
1. Base Business and NPI Engineering:
- Adheres to all safety and quality requirements including but not limited to: Quality Systems, 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 metals machining, sheet metal fabrication, and sub-processing such as assembly, powder coat, and metal finishing, welding, laser cutting, and electrical harness assembly.
- Performs root cause analysis to identify and implement needed process improvements eliminating waste
- Defines, produces and implements documents including standard work and process work instructions.
- Identifies, develops, justifies, and executes detailed project plans for engineering work with minimum supervision.
- Ability to launch new products effectively in a contract manufacturing environment.
- Investigates, develops and implements new process technologies.
- Successfully communicates complex issues with customers and internal team members.
- Creates, reviews and approves engineering drawings, equipment layouts, change orders and specifications.
- Develops tooling, fixtures and equipment used in manufacturing to optimize productivity and cost.
- Effectively owns and manages CAPAs pertaining to their areas of responsibility.
- Collaborates with development, programmers, machinists and suppliers to evaluate designs for manufacturability and cost reduction.
- Creates and executes validation protocols, processes and material evaluations.
2. Costing Engineer:
- Develop costing for new business opportunities across multiple sites to support small-format machining.
- Collaborate with company SMEs to determine optimal approaches for processes, machine cycle times, equipment selection, fixture design, and automation.
- Identify, document and communicate to the customer DFM opportunities to positively impact cost, quality, and delivery.
- Partner with Commercial to provide technical support when delivering customer proposals to build confidence in the manufacturing process quoted.
- Investigates new technologies and capabilities, with a focus on improving competitiveness in cost structure to increase value to customers and our business.
The successful candidate will:
- Plan and execute projects, with minimum supervision, on time and within budget to achieve tangible results.
- Drive improvements through root cause analysis and data driven decision-making.
- Participates in cross-functional project teams to propose and implement creative solutions.
- Ensure internal and external customer expectations are met or exceeded.
- Develop accurate quotes with a strategic mindset of how to best serve the customer and the business
- Manage assigned quotes to ensure timely completion
Requirements
- Engineering or bachelor’s degree in a technical field.
- 7+ years of work experience in similar technical roles including medical device manufacturing required
- Strong problem-solving skills.
- Ability to provide solid rational and justification for process proposals and improvement change requests
- Lean manufacturing and new product development or launch support experience is highly desirable.
- Understanding of metals machining, sub-processing, assembly, and inspection is strongly preferred.
- Ability to collaborate in a team environment.
- Strong written and oral communication skills.
- Experience in medical devices is preferred.
- Proficiency in Microsoft Office Suite
- Working knowledge of ISO and FDA regulations and GD&T
