PURPOSE OF JOB

This role is responsible for the following areas: In-house and contracted manufacturing, Process Development, New Product Introduction, equipment and process controls/qualification, and ensuring all activities follow GDPGMP guidance and are compliant to the Inquis Quality Management System. This position will ensure that projects/products/processes are designed to facilitate manufacturability and will be responsible for technology transfer to manufacturing and scalability.

MAJOR DUTIES AND RESPONSIBILITIES

• Develop manufacturing processes, Manufacturing Process Instructions (MPI’s) and lot history records (LHR’s) in collaboration with R&D and Quality.
• Oversee the design, development, and qualification of fixtures, equipment, and processes for Inquis products (IQ/OQ/PQ).
• Manage assigned in-house and contract manufacturing activities and relationships to ensure products are manufactured in accordance with product plans and quality/regulatory requirements.
• Refining and optimizing existing manufacturing processes to improve product variability and reduce Cost of Goods
• Manage New Product Introductions into manufacturing and commercial ramp
• Assist in supplier development and component specification improvements to ensure component reliability.
• Manage materials necessary for qualifications/validations for assigned engineering projects. Ensure accurate inventory, raw materials, and component specifications and requirements.
• Develop metrics and execute studies necessary to characterize and improve operation processes (time studies, production metrics, etc.).
• Ensure that all products are manufactured in compliance with the company Quality System, customer needs, budgetary requirements, schedule requirements, and the Regulatory requirements.
• Work with Quality, Regulatory, and R&D teams to define required verification inspections and validation protocols/systems and continuous monitoring systems necessary to meet scalability requirements.
• Resolve quality and yield issues through continuous improvement projects.
• Create, maintain, and manage manufacturing tasks of project schedule, and ensure that critical timelines and/or budgets are established and met.
• Participate in manufacturing team meetings to ensure adequate communication between members and develop positive, proactive working relationships with other staff.
• Work with R&D staff to ensure smooth transition of products into manufacturing while assuring manufacturability, achieving cost targets and conformance with regulatory and quality requirements.
• Work with suppliers to ensure parts/services are properly documented and meet specifications.
• Train/Certify the MPI Trainer for manufacturing process instructions; may train other staff as needed.

EDUCATION REQUIREMENTS

• BS or MS in Engineering or related discipline or equivalent experience in the medical device industry

EXPERIENCE REQUIREMENTS

• Minimum 10 years manufacturing experience in FDA regulated medical devices or

related industry

• Experience in manufacturing and controlling sterile product
• Experience in manufacturing catheter and delivery systems
• Experience with procuring and working with braid, coiled, and laser cut hypotube reinforced polymeric shafts.

REQUIRED SKILLS/ ABILITIES

• Knowledge of and experience in pilot/production line set-up and validation in Controlled Environments
• Experience working under quality system designed to meet governmental regulations such as FDA QSR, ISO 13485, the MDR, and knowledge of relevant standards
• Ability to detail project plans effectively
• Familiar with developing Master Validation Plans & executing operational and performance validations
• Familiar of GMP, GDP procedures and requirements
• Familiar with Design Control procedures and requirements
• Excellent verbal and written communication skills are required

• Experience working to environmental health and safety regulations
• Project management experience preferred