JOB DESCRIPTION

JOB TITLE:

Senior Design Engineer Lead design and testing of complex Class III catheter based cardiac medical devices, develop performance specifications of products and implement innovative solutions to meet product requirements, evaluate drawings and mechanisms for form, fit, and function, and interface with mold-makers, tooling suppliers and outside resources.

ESSENTIAL DUTIES AND RESPONSIBILITIES

(List of 8 - 10 key tasks required of the job which occupy greater than 5% of the incumbent's time) Design class III medical device systems, components and accessories to meet quality, schedule, and COGs targets. Perform rapid prototyping in a dynamic environment, including use of 3D printing technology Develop detailed CAD models and technical drawings Research and procure components for design prototypes and commercial products Create and maintain accurate documentation of design concepts, test results, and concepts in accordance with the company procedures. Test and evaluate products according to quality standards and performance specifications. Perform Root Cause Analysis on device failures and implement corrective actions Design and develop manufacturing processes, fixtures, and tooling. Providing engineering support in the production department.

SUPERVISOR RESPONSIBILITIES

(IF ANY) - (List of subordinate jobs for which this job has direct hire/discipline/budget responsibility) This position has no supervisory responsibility.

MINIMUM QUALIFICATIONS

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements 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.

EDUCATION AND/OR EXPERIENCE

BS or MS in Mechanical Engineering or equivalent experience 5-10 years of experience in product design

CERTIFICATES, LICENSES, REGISTRATIONS

None required.

ESSENTIAL KNOWLEDGE, SKILLS AND ABILITIES

Experience in new product conceptualization, design, and implementation. High proficiency with Solidworks CAD software. Experience with injection molding, machining, 3d printing. Extensive experience in component and mechanism design. Design for manufacturability. Experience with technical writing (ideally test protocol development and execution). Documenting root cause analysis (ideally also performing investigation). Familiarity working within a regulated environment (ideally Class III medical device design using catheters for cardiac and structural heart).

TRAINING REQUIREMENTS

(INTERNAL/EXTERNAL): Quality System knowledge. Anatomy training. SOP training as identified on the MID Training Matrix.

PHYSICAL DEMANDS

(e.g., expectations of such items as weight needed to move or lift) none

WORK ENVIRONMENT

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