Job Description

Company Description:

AtaCor Medical is committed to advancing the standard of care in cardiac rhythm management. This mission drives our innovative approach and guides our work to help physicians restore rhythm and preserve life.

Position Summary:

This position supports the design and development of new products and product improvements in the extravascular cardiac rhythm management space. Responsibilities will include creation and evaluation of design requirements, development and execution of design verification test methods/protocols/reports, supplier interface and multi-disciplinary project team participation. This position is a full-time, on-site role located at our San Clemente, CA office. 

Essential Functions:

• Provides engineering support for design and development of new products and product changes
• Use computer-assisted design software (i.e., SolidWorks) to perform engineering and design tasks
• Develops and tests prototypes based on design specifications, defines processes to properly manufacture and assemble the product, and optimizes the manufacturing process
• Analyzes test data to determine if designs meet functional and performance requirements and document findings in test reports
• Conduct engineering inspections of returned product from clinical studies to support complaint and CAPA investigations
• Support updates and improvements to QMS procedures
• Evaluate the impact of external standard changes on products and their Design History Files (DHFs)
• Leverage knowledge of Risk Management, Regulations, and Procedures to ensure continued product compliance
• Provides design verification test reports, drawings, and other requirements to Regulatory Affairs necessary for preparing regulatory notifications and submissions such as 510(k)s and PMAs for domestic and international approvals as required
• Determines realistic start and finish dates for action items imperative to project completion on the project schedule and submits to the project team leader. Provides updates to project schedule as required
• Identify areas for improvement in lab tooling and technical processes across all project phases and recommend changes to the appropriate management.
• Supports management of Engineering Lab and provides technical training for appropriate Lab personnel
• Reviews appropriate technical literature for the necessary background on specific assignments
• All activities must be performed in compliance with the Quality System
• Performs duties in compliance with environmental, health, and safety-related site rules, policies, or government regulations

Essential Qualifications:

• Education : BS in Biomedical Engineering, Mechanical Engineering, or equivalent combination of education and experience.
• Experience : 0-3 years industry experience, preferably in medical device design environment.
• Working knowledge of light machine shop practice and operation; ability to use shop tools such as drill press, drills, heat sealer, and pull test equipment.
• Working knowledge of current CAD tools
• Experience in the use of analytical tools and methods including statistics, DOE, and computer analysis packages.
• Excellent teamwork and interpersonal skills.
• Travel : Up to 15-25%

Desirable Skills:

• Experience with SolidWorks
• Experience working within an ISO or FDA type design control environment.
• Experience working with a contract engineering or manufacturing firm.
• Cardiac pacing/defibrillation, implantable, or surgical medical device experience

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