Job description

Job Description

The client is seeking a hands-on Manufacturing Engineer with experience in Medical Device consumable manufacturing and a passion for shepherding new products to market.

Essential Job Responsibilities

• Oversee and manage design transfer and process transfer activities for a consumable product manufacturing.
• Optimize line layout, install new equipment, write IQ/OQ/PQ equipment protocols and assist and or oversee the execution and documentation of those protocols.
• Improve manufacturing processes by matching process output to product requirements and testing requirements to reduce cycle time and improve yield.
• Ensure test methods appropriately demonstrate product quality requirements.
• Improve existing Work Instructions. Train technicians to Work Instructions.
• Improve manufacturing efficiency and reduce cost by analyzing and planning workflow, space requirements, and equipment layout.
• Implement process metrics and track and report on metrics to monitor health of the manufacturing line.
• Communicate results effectively, guiding the team through data and observations on critical process decisions.
• Coordinate with cross-functional project teams to ensure timelines are met and assist the team to balance costs, timeline, and performance.

Essential Qualifications

• Experience with Design Transfer to Manufacturing and New Product Introduction
• Experience with Design for Manufacturability
• Experience working closely with contract manufacturing partners and vendors
• Experience with Scale up of consumable manufacturing in a GMP and ISO13485 environment
• Strong analytical and problem-solving skills
• Hands-on and able to set up processes and troubleshoot independently
• Ability to manage different priorities and plan experiments around various constraints
• Self-starter, ability to work without supervision
• Excellent verbal and written communication skills
• Computer skills such as setup of equipment software, standard Office programs such as Word, Excel, Powerpoint.

Job Requirements

• BS/MS in Engineering or related discipline
• Experience with CAD software such as Solidworks
• 7+ years work experience with fabrication and manufacturing of consumables in a regulated environment.Experience with laser welding of plastic components and assembly of microfluidic consumables a plus

Experience with injection molding and partnering with injection molding suppliers also a plus

Job Type: Full-time

Salary: $100,000.00 - $130,000.00 per year

Benefits:

• 401(k) matching
• Health insurance
• Life insurance

Schedule:

• 8 hour shift

Supplemental pay types:

• Bonus pay

Ability to commute/relocate:

• Jeffersonville, IN 47130: Reliably commute or planning to relocate before starting work (Required)

Work Location: One location

Speak with the employer
+91 +13022164931

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