Senior Process Engineer job
Job Reference number: 225539
We are a global medical contract manufacturing leader specializing in the design, manufacture, assembly, and lifecycle management of components and finished devices. For nearly 30 years, medical device and healthcare companies worldwide have looked to our team to make a difference as the premier custom manufacturer that medical industry leaders can trust.
We are looking for a Senior Process Engineer who:
- has experience providing troubleshooting skills and trains shop floor personnel in problem solving methodology (Medical Device experience not required)
- is responsible to implement continuous improvement on the Production Floor and support the flawless launch of new products to production through the development, validation of new tools and processes
- is self-motivated and thrives in a fast –paced, team-driven, “lean” systems environment, where every day brings new projects and challenges.
Sound like you? Keep reading!
- Comprehensive benefits package
- 401k with company match
- Paid vacation and paid holidays
- 529 College Savings Program
- Paid short- and long-term disability plans
- Employee assistance program
What You Will Be Doing
- Trains production personnel on process enhancements and troubleshooting methodology
- Supports Production Floor in identifying root cause, and corrective action implementation of daily Production Related issues across all three shifts
- Participates as a team member on assigned projects using established APQP Project Management tools - Advises management of any cost related issues for assigned projects – makes recommendations to optimize mold/part design as required
- Interfaces with customers and suppliers on project matters as required
- Aids with short- and long-term planning for capital expenditures relating to future production requirements; leads projects involving new capital implementation
- Maintain a vigilance to identify new potential technologies for the company.
- Conduct internal audits and assists with maintaining the Quality System to ISO-13485 standards.
- Ability to support Production and New Business needs on Off-Shift and Weekends as required
What You Need for this Position
Additional expected qualifications:
- Scientific injection molding background
- Technical experience in Injection Molding processes, material behavior and mold design for mold ability
- Experience programming/troubleshooting/installing automation
- Experience writing procedures, work instructions, and other related documents
- Previous experience in managing multiple projects simultaneously
- Familiarity with statistical problem solving techniques
- Working knowledge of validation (IQ/OQ/PQ)
- Proven success at managing cost budget and achieving financial justification for Capital Purchases
- Previous experience working in a small manufacturing environment
- Experience with Injection Molding of silicone
- Previous experience in a manufacturing environment of medical or healthcare products and familiarity with ISO-13485 and FDA CFR 21 regulations
- Six Sigma Green Belt or Black Belt certification
Are you a fit for this position?
- Process Engineering
- Scientific Injection Molding Background
- Injection Molding of Plastics
- Plastics Engineering
- Mold Design
- Working Knowledge of Validation (IQ/PQ/OQ)
- Continuous Improvement on the Production Floor
- Injection Molding of Silicone
- ISO 13485 / FDA CFR 21
- Six-Sigma Green Belt/Black Belt