Quality Engineer

Top skills needed:

1. Medical device experience
2. Complaint handling experience preferred
3. Product Risk Management experience/Post market quality experience preferred

Education Required: Bachelor’s/Master’s in Biomedical/ Mechanical/Electrical Engineering

Years’ Experience Required: 1-5

Does this position require the candidate to be onsite or remote, if hybrid what does the onsite vs remote schedule look like? Hybrid (2 days remote, 3 days on-site)

In this exciting role as Quality Engineer, you will develop, modify, apply, and maintain quality standards and protocols for post market analysis. Perform complex failure analysis of devices/components returned with alleged malfunctions. Collaborates with engineering, product development, complaint management, supplier quality and manufacturing functions to ensure returned product investigations fully address reported events. Develop and implement methods and procedures to assist in product analysis investigations. Provide direction for failure analysis technicians to ensure that field returns are evaluated appropriately to deliver clear investigation results and potential root causes for identified failures. Initiate discussions with management, Field Assurance, and QA when new failure mode(s) is(are) identified during failure analysis.

Mechanical Circulatory Support

The Mechanical Circulatory Support Operating Unit is responsible for the copmany's heart pump program. Called the HeartWare™ HVAD™ System, this business provides a left ventricular assist device (LVAD) that helps patients’ hearts pump and increases the amount of blood that circulates through their bodies. The HVAD System features the world's smallest, commercially available, centrifugal flow pump.

• Collaborates with engineering and manufacturing functions to ensure quality standards are in place.
• Ensures that corrective measures meet acceptable reliability standards, and that documentation is compliant with requirements.
• May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality
• Completes comprehensive review of HVAD log files to determine correlation between the reported event and electro-mechanic components.
• Reviews HVAD system testing results including but not limited to: profilometer measurements, front/back impeller pre-loads, axial gap measurements, in-vitro wet-test functional parameters, and stators conductivity results to determine a most probable root cause associated with a reported event.
• Determines potential interaction between reported event and all HVAD system components controller, batteries, pump, monitor, AC adapter, batterie charger, and surgical tools.
• Generates comprehensive HVAD product investigation reports to support findings, root cause, regulatory requirements and obtains the necessary release approvals.
• Creates and develops engineering projects for improvements of analysis/investigation process to eliminate process waste and reduce rework rates.
• Participates and/or conducts validation or qualifications tests of new or existing failure analysis equipment in accordance with internal procedures.

TECHNICAL SPECIALIST CAREER STREAM: An individual contributor with responsibility in our technical functions to advance existing technology or introduce new technology and therapies. Formulates, delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering R&D, systems or initiatives related to new technologies or therapies – from design to implementation - while adhering to policies, using specialized knowledge and skills.

DIFFERENTIATING FACTORS

• Autonomy: Entry-level individual contributor on a project or work team.
• Works with close supervision.
• Organizational Impact: Delivers work of limited scope, typically smaller, less complex projects or related activities.
• Innovation and Complexity: Identifies, defines and addresses problems that are not immediately evident but typically not difficult or complex.
• Makes minor changes in systems and processes to solve problems.
• Communication and Influence: Communicates primarily with internal contacts within immediate group.
• Contacts others to gather, confirm and convey information.
• Leadership and Talent Management: N / A – job at this level is focused on self-development.
• Required Knowledge and Experience: Requires broad theoretical job knowledge typically obtained through advanced education.
• Requires a Baccalaureate degree.