Supports medical device manufacturing, test method validation, equipment qualification, design transfer, and regulated documentation for catheter and disposable product development. Job Requirements 2-5 years of medical device manufacturing engineering, R D engineering, or related regulated manufacturing experience. Knowledge of Good Manufacturing Practices (GMP). Experience evaluating, operating, and documenting mechanical test fixtures and jigs. Experience performing Gage R&R studies and confirming measurement system accuracy. Experience with test method development and test method validation. Experience implementing manufacturing or process improvements. Experience supporting vendors, supply chain activities, or procurement logistics. Knowledge of injection molding, polymers, and materials commonly used in medical devices. Working knowledge of metal processing. Experience creating and managing Bills of Materials (BOMs), Engineering Change Requests (ECRs), and controlled documentation within a Quality Management System (QMS). Experience with disposable medical device manufacturing processes. Experience with mechanical design for medical devices. Proficiency with CAD software. Experience with equipment validation in a regulated manufacturing environment. Experience with Failure Modes and Effects Analysis (FMEA). Preferred Skills SolidWorks experience. Catheter development or manufacturing experience. Experience supporting design verification activities. Experience supporting design transfer to contract manufacturers. Experience with

IQ/OQ/PQ

equipment validation. Experience managing laboratory inventory and prototype materials. Experience developing inspection procedures for production environments. Experience supporting contract manufacturing operations. Job Responsibilities Develop and maintain manufacturing procedures for catheter prototypes and disposable medical devices. Generate, organize, and analyze manufacturing and test data. Develop and validate test methods for product and process verification. Establish inspection procedures for manufacturing operations. Perform Gage R&R studies and verify measurement system capability. Evaluate, operate, and document mechanical testing fixtures and jigs. Prepare fixture evaluation reports and usage documentation. Support equipment qualification and validation activities, including IQ, OQ, and PQ. Support design transfer of product and process changes to contract manufacturers. Manage BOMs, ECRs, procedures, test records, and related documents within the QMS. Maintain inventory controls for prototype and design verification materials. Coordinate materials and procurement activities to prevent shortages during development and verification. Support vendor and supply chain activities related to prototype and manufacturing materials. Apply knowledge of injection molding, polymers, metal processing, and disposable manufacturing processes to product development and manufacturing activities. Support mechanical design activities using CAD tools. Develop and maintain FMEA documentation as required. Support cross-functional product development activities involving engineering, quality, regulatory, clinical, manufacturing, and supply chain functions.

Pay:

40-60/hr Benefit offerings include medical, dental, vision, term life insurance, short-term disability insurance, additional voluntary benefits, commuter benefits and 401K plan. Our program provides employees the flexibility to choose the type of coverage that meets their individual needs. Available paid leave may include Paid Sick Leave, where required by law; any other paid leave required by Federal, State or local law; and Holiday pay upon meeting eligibility criteria.

Disclaimer:

These benefit offerings do not apply to client-recruited jobs and jobs which are direct hire to a client.

Pay Details:

The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable: The California Fair Chance Act Los Angeles City Fair Chance Ordinance Los Angeles County Fair Chance Ordinance for

Employers San Francisco Fair Chance Ordinance Massachusetts Candidates Only:

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.