Senior Operations Engineer II

Senior Operations Engineer II

Job Title Senior Operations Engineer II FLSA Salaried Exempt Department Operations Reports To Operations Manager Download the job description

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Job Responsibilities:

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 focus on vendor management. 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.

• Supports and leads manufacturing process improvements for both internal manufacturing facilities and in partnership with external suppliers.

• Refines existing specifications, leads process improvement projects, creates validation testing, and makes product yield enhancements and cost reductions.

• Researches and recommends vendor and material choices for product. Prepares and delivers status reports.

• Develops and implements quality inspection procedures, including sampling plans, for production level components and finished goods.

• 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.

• Maintains compliance of quality related logs and records, including but not limited to, CAPA, NCR, ASL, CAL/PM, and Training.

• Establishes, implements, and maintains company Quality System in compliance with FDA, International Standards (ISO), and other regulatory agencies.

• Provides assembler/operator training and contribute to the development of support materials as required.

• Manages communication and acts as supporting liaison with regulatory agencies on compliance issues, including registration and licensing of facilities and regulatory agency audits and inspections.

• May work directly with the company/customer representative to determine needs in product repairs, complaints analysis and user interface.

• Researches, designs, and develops new processes and current product enhancements in accordance with Quality System requirements.

• Provides input regarding appropriate statistical methods, test methodologies, test facilities, and equipment.

Projects and Other Duties:

• Perform other duties as assigned.

Position Qualifications

• Skilled in the use of CAD software such as Auto cad, SolidWorks, and/or Pro E.

• Knowledge of and exposure to product testing and data collection.

• Familiar with Design Control procedures and requirements.

• Ability and willingness to travel.

Minimum Education:

• Bachelor's degree in a relevant engineering discipline such as Mechanical Engineering, Biomedical Engineering, or equivalent.

Minimum Experience:

• 4+ years in medical device design or similar products, Class II or III devices preferred.

• Highly motivated and target driven with a proven track record.

• Prioritizing, time management and organizational skills.

• Ability to create and deliver presentations tailored to the needs of the audience.

• Relationship management skills and openness to feedback.

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 $110,000 to $130,000 (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.