R&D Process Development Engineer

Summary: Seeking an R&D Process Development Engineer to design and optimize processes for manufacturing new medical devices.

Job Requirements:

• Bachelor's degree in Engineering

• Must be a US Citizen

• 3-5 years of solid engineering experience

• Experience in Class II/III medical device manufacturing or GMP regulated environment

• Knowledge of process validation, design for manufacturing, statistics, and lean manufacturing principles

• Familiarity with ISO 13485/FDA practices and GMP standards

• Experience with CREO and process development

Preferred Skills:

• Knowledge of 3D Modeling software (Creo, SolidWorks, etc.)

• Proficiency in Microsoft Office Software (Word, Excel, Visio, PowerPoint, MS Project)

Job Responsibilities:

• Design and optimize processes for new medical device manufacture

• Identify and evaluate innovative processing options based on product attributes

• Execute cost-effective systems to enhance processing speed and quality while ensuring compliance with regulations

• Collaborate with R&D team, Operations, and Production engineering for effective project completion

• Responsible for process documentation (PFMEAs, Production Instructions, Drawings)

• Define, identify, and procure new equipment for manufacturing processes

• Adhere to Quality Management System processes to meet regulatory requirements

Pay Details: $38.00 to $51.00 per hour

Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.

Equal Opportunity Employer/Veterans/Disabled

To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to https://www.entegee.com/candidate-privacy-information-statement/

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