Job Description

Job Title: Prin Quality Engineer with Electromechanical Medical Devices

Duration: 12 Months

Location: Irvine, CA - 92617

Must Skill:

• Experience with Risk Management for medical devices.
• Experience with electrophysiology/electrical/electromechanical medical device.
• Experience with Regulations for electromechanical medical devices.
• Ensures product development activities are conducted in accordance with FDA, QSR, ISO 13485 and internal Quality System requirements.

Nice to Have:

• Experience with exploratory, early stage in-human clinical trials.
• Self-motivated, driven and committed to a team approach
• Strong interpersonal, organizational and project management skills
• Strong oral, presentation and technical writing skills.
• Ability to dissect, condense, and disseminate information appropriately to key stakeholders.

JOB DESCRIPTION:

• Responsibilities may include the following and other duties may be assigned.
• Collaborates with cross OU to harmonize the design quality requirements/deliverables/procedures and implement to the program.
• Experienced in the areas of electrophysiology/electrical/electromechanical engineering design medical device / regulation
• Develops, modifies, applies and maintains quality standards and protocol for verification and validation during design/development process.
• Collaborates with engineering and manufacturing functions to ensure quality standards are in place.
• Advices and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment.
• Create and maintain the risk register on a developing product and communicate to the stakeholders.
• Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications.
• Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.
• May specialize in the areas of electrophysiology, electrical engineering design, incoming material, protocols, performance evaluation and reliability, research and development as they apply to product or process quality.

SPECIALIST CAREER STREAM:

• Typically, an individual contributor with responsibility in a professional discipline or specialty.
• 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 and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University).

DIFFERENTIATING FACTORS Autonomy:

• Recognized expert, managing large projects or processes. Exercises considerable latitude in determining deliverables of assignments, with limited oversight from manager. Coaches, reviews and delegates work to lower level specialists.
• Organizational Impact: Contributes to defining the direction for new products, processes, standards, or operational plans based on business strategy with a significant impact on work group results. May manage large projects or processes that span outside of immediate job area.
• Innovation and Complexity: Problems and issues faced are difficult, moderately complex and undefined, and require detailed information gathering, analysis and investigation. Develops solutions to moderately complex problems, and/or makes moderate to significant improvements of processes, systems or products independently to enhance performance of job area. Implements solutions to problems. Communication and Influence: Represents organization as a primary contact for specific projects and initiatives; communicates with internal and external customers and vendors at various levels. May negotiate with others to reach understanding or agreement, and influence decision-making.
• Leadership and Talent Management: Typically provides guidance, coaching and training to other employees within job area. Typically manages major / moderately complex projects, involving delegation of work and review of work products, at times acting as a team leader.

Required Knowledge and Experience:

• Requires mastery of a specialty area and full knowledge of industry practices, typically obtained through advanced education combined with experience.
• May have broad knowledge of project management. Requires a University Degree and minimum 7 years of relevant experience, or advanced degree with a minimum of 5 years of relevant experience.

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