Operations Engineer – Change Management

Operations            ·             Irvine, CA              ·              Full time

Job Title: Operations Engineer – Change Management
FLSA: Salary Exempt
Department: Operations 
Reports To: VP Operations/ Manager of Operations 
To apply, e-mail your resume to careers@axonics.com

Job Scope and Quality Impact:

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

General Description and Duties:

To perform this job successfully, an individual must be able to perform each essential job task satisfactorily. The tasks listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Reviews and approves assigned controlled documents (e.g., work instructions, quality specifications, engineering specifications, procedures and validations protocols). Ensures that product documentation is in accordance with Quality System requirements. Responsible for executing document control activities including document control processing from number issuance to reviewing, approving, collecting approval signatures, and executing implementation activities.
• Collaborates with engineering and operations teams to update or create drawings, specifications, and process documentation.
• Performs impact analysis of documentation changes and updates other affected documents as required.
• Verifies that document updates follow a standardized process for accuracy, formatting, and content presentation.
• Maintains changes of documents and associated CAD assembly drawings, ensuring alignment between PLM and PDM systems.
• Communicates product structure changes to Finance and Operations teams to aid in cost accounting and inventory management.
• Maintains compliance of quality related logs and records, including but not limited to, CAPA, NCMR, APSL, CAL/PM, and Training. Establishes, implements, and maintains company Quality System in compliance with FDA, International Standards (ISO), and other regulatory agencies.
• Understands and participates in performing risk assessments (dFMEA, pFMEA, etc.) and process validations, including writing and execution of protocols and reports.
• Participates in resolution of NCMRs, complaints, CAPAs, and root cause investigations.

Projects and Other Duties:

• Perform other duties as assigned.

Position Qualifications

• Knowledgeable in the use of CAD and associated Product Data Management (PDM), such as SolidWorks, AutoCAD, Creo, etc.
• Knowledge of electronic change management (PLM) systems.
• Familiar with Design Control procedures and requirements.
• Familiarity with ISO 13845 and FDA 21 CFR 820 and applications in a medical device space.
• Ability to reliably commute or planning to relocate before starting work.

Minimum Education:

• Biomedical, Chemical, Mechanical, Electrical, or any engineering or technical degree or equivalent experience.

Minimum Experience:

• 2-5 years’ experience in related engineering/manufacturing of Class II or III medical devices is preferred based on the engineering level. Equivalent experience in other regulated environments is acceptable. Prior manufacturing experience is preferred but not required.
• Experience working under regulated quality systems such as cGMP’s, ISO, and the MDR.

Salary:

Aligning our overall business objectives with performance and merit based pay, Axonics offers competitive salaries, performance-based incentives, and Employer paid benefits programs to address the diverse individual needs of our employees and their families. At Axonics, our employees come first!

For California, the base pay range for this position is $80,000 to $100,000 (highly experienced).

The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience).

Axonics is an Equal Opportunity Employer, included protected Veterans and individuals with disabilities.

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