Operations Engineer sought by Axonics, Inc. in Irvine, CA.

Operations        ·      Irvine, CA       ·       Full time

Job Title: Operations Engineer
FLSA: Salary Exempt
Department: Operations
Reports To: Director of Operations

Job Responsibilities:

Responsible for contributing to the design, development and manufacturability of specific product(s) in accordance with the company’s Quality System and customer requirements. Ensure that assigned projects and/or product(s) are designed for technology transfer from R&D to manufacturing and facilitate improved manufacturability. Comply with the Quality System by engaging in appropriate levels GMP/ISO test methodologies, adherence to Quality System Design Controls and apply proper documentation skills.

Specific duties include:

• Refine existing specifications, develop process improvements, create validation testing and make product yield enhancements and cost reductions.
• Research and recommend vendor and material choices for product.
• Prepare and deliver status reports.
• Develop and implement quality inspection procedures, including sampling plans, for production level components and finished goods.
• Review and approve assigned controlled documents (e.g. work instructions, quality specification, engineering specification, procedures and validation protocols); as well as ensure that product documentation is in accordance with Quality System requirements.
• Maintain compliance of quality related logs and records, including but not limited to, CAPA, NCR, ASL, CAL/PM and Training.
• Establish, implement and maintain company Quality System in compliance with FDA, International Standards (ISO) and other regulatory agencies.
• Manage communication and act as supporting liaison with regulatory agencies on compliance issues, including registration and licensing of facilities and regulatory agency audits and inspections.
• Work directly with the company/customer representative to determine needs to product repairs, complaints analysis and user interface; and provide assembler/operator training and contribute to the development of support materials as required.
• Research, design and develop new processes and current product enhancements in accordance with Quality System requirements.
• Provide input regarding appropriate statistical methods, test methodologies, test facilities and equipment.

Job Requirements:

• Requires a Master’s degree in Biomedical Engineering, Medical Device and Diagnostic Engineering, Engineering or related field, plus six (6) months of experience in research, design, development, testing, troubleshooting, and documentation of products and processes in compliance with Quality System and Regulatory requirements in the medical device industry.

Specific skills:

Position also requires education or experience in the following:

• Experience in Class II or III medical devices;
• Experience working under regulated quality systems such as cGMP’s, FDA, ISO and MDD;
• Experience using multiple tools and equipment to support Regulatory Affairs submissions;
• Knowledge of laser welding and brazing;
• Knowledge of ERP and EDI; and
• Knowledge of CAPA, Complaint and NCMR

Any level of knowledge, experience and/or coursework in the specific skills is acceptable.

To apply, e-mail your resume to sthomson@axonics.com

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