What are the responsibilities and job description for the Manufacturing Engineer position at Protingent?
Job Description
Job Title: Manufacturing Engineer
Position Description: Protingent Staffing has an exciting direct hire Manufacturing Engineer with our client.
Job Description:
Job Title: Manufacturing Engineer
Position Description: Protingent Staffing has an exciting direct hire Manufacturing Engineer with our client.
Job Description:
- The Manufacturing Engineer develops, maintains, and continuously improves the manufacturing lines, equipment, processes, and training used on the production floor.
- As a hands-on owner of how manufacturing is done, this role ensures that production can reliably meet the business demands while manufacturing high quality products.
- The Manufacturing Engineer oversees and maintains process and equipment improvements, supports new product introductions, and partners with cross-functional teams to optimize production efficiency, quality, and consistency.
- Creates, maintains, and continuously improves the manufacturing systems (processes, equipment, training, etc.) used to manufacture the medical devices, for both existing and new designs
- Specifies, develops, and maintains production line test methods, processes, and fixtures; ensures test approaches are repeatable, scalable, and support the business needs
- Troubleshoots production line issues to eliminate equipment and material as a source, and implements corrective and preventive actions on the production floor; escalates issues to engineering teams as necessary to
- Identifies, scopes, and justifies capital equipment needs for manufacturing investments
- Stays current with manufacturing industry practices and technologies to help keep the production environment robust, efficient, and scalable
- Ensures processes and systems align with applicable regulations (FDA 21 CFR Part 820, ISO 13485, 2017/745/EU Medical Device Regulation); supports internal and external audits from FDA and Notified Bodies
- Supports the development and continuous improvement of equipment calibration program, executing in-house and outsourced calibration activities to ensure compliance and efficiency
- Partners with other departments such as R&D, Supplier Quality, IT, Production, Regulatory Affairs, and Quality Assurance to ensure smooth design transfers and efficient day-to-day operation of the production environment
- Supports the Manufacturing Engineering team through the NPI and design transfer processes; helps ensure that designs and their manufacturing processes are robust and repeatable
- Perform other duties as assigned.
- Working knowledge of Process Engineering and Optimization to improve efficiency, utilization, throughput and yield
- Working knowledge of the device manufacturing environment and problem solving within its unique technical, regulatory, and operational challenges
- Knowledge of and experience with change control processes and activities
- Knowledge of design-for-manufacture concepts and their practical application during the engineering development process
- Knowledge of the Manufacturing Engineering discipline as it applies to NPI, including production line setup, test procedure development, and measurement of manufacturing system performance against defined acceptance criteria
- Familiarity with New Product Introduction (NPI) and the design lifecycle, with hands-on experience supporting programs from engineering development through manufacturing validation, production release, and ongoing manufacturing support of active designs
- Working knowledge of Continuous Improvement processes (i.e. Lean Manufacturing - Six Sigma, Kaizen, 5S, etc.)
- Familiarity with Automation and Technology Integration; exposure to practical applications of technologies and smart manufacturing integration to increase quality and reduce rework
- Ability to analyze data and situations, exercise sound judgment, plan and organize work, and communicate effectively across teams
- Ability to identify and communicate risk with appropriate urgency, helping keep manufacturing programs on schedule with consistent follow-through on execution
- Bachelor’s degree in engineering or equivalent experience
- Typically has greater than two (2) years of relevant professional or technical engineering experience
- Typically has experience manufacturing regulated equipment. Ideally this experience is in a medical or similar safety-conscious, highly regulated industry.
- Job Type: Direct Hire
- Salary Range: $79-100K.
- Location: Kennewick, Washington (Onsite)
- Due to government contract requirements, this position is restricted to U.S. Citizens/GC Holder only.
Salary : $79,000 - $100,000