POSITION SUMMARY:

Performs complex activities in the design and testing of class II and class III mechanical circulatory support products including VADs, extracorporeal blood pumps, oxygenators, and CPB cannula. Provides technical solutions to a wide range of difficult problems. Exercises considerable latitude in determining technical objectives and solutions of assignments. May direct projects and activities of other Engineers and Technicians.

RESPONSIBILITIES:

• Research, design, develop, and test electromechanical devices for VAD and CPB applications

• Work with cross-functional teams for development of new products, and improvement to existing products driven by corrective and preventative actions (CAPA)

• Establish requirements (User Needs and Design Input Requirements) and specifications for these products

• Use experimental, empirical, and numerical analysis to evaluate designs.

• Develop and qualify (IQ/OQ) fixtures/equipment for verification testing

• Investigate issues and identify root causes in complex systems where analysis of situations or data requires an in- depth evaluation of various factors

• Identify and mitigate both technical risks and program (scope, schedule, budget) risks

• Create/review technical drawings for appropriate assembly, dimensioning, and tolerancing

• Support projects in various capacities: i.e. as an individual contributor, as technical lead of a small team, or a subject- matter expert/consultant

• Maintain a detailed understanding of the developing clinical environment (e.g. current treatment methods, evolving clinical needs etc.).

• Provide input and support to Regulatory Affairs for FDA/global regulatory submissions

• Aid in vendor evaluations such as manufacturing capability and capacity, engineering support, and quality controls

• Complies with FDA regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors

• Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.

MINIMUM QUALIFICATIONS:

• B.S. in Mechanical, Biomedical, or Manufacturing Engineering.

• 8+ years engineering experience including product development, process development, risk assessment, and V&V verification related to class II/III medical devices

• Industry experience with FDA design controls 21 CFR 820.30

• Strong communication and presentation skills (e.g. versatility communicating with peers, management, auditors/regulators, and customers)

• Ability to travel approximately 10%, primarily in the US, but may include international)

PREFERRED QUALIFICATIONS:

• Design and V&V of class II/III electromechanical medical devices, such as VADs, extracorporeal blood pumps, oxygenators, CPB cannula, or other implantable devices

• Experience with medium to high volume medical device manufacturing

• Experience with a variety of manufacturing processes and designing for manufacturability Industry experience with EU MDR, ISO 13485, and standards for medical devices (e.g. biocompatibility, sterilization, labeling, packaging, etc)

• Experience with CAD design, SPC/six sigma, DOE, and project management