Sr Reliability Engineer

Location:

Santa Ana, California, United States of America

Salary range: $107K - $161K (USD)

Responsibilities may include the following and other duties may be assigned.

• Lead as a quality extended team member responsible for driving design, development, and implementation of testing methods and equipment.
• Compile data and define changes required in testing equipment, testing procedures, manufacturing processes, or new testing requirements.
• Participate in risk management activities including system risk analysis (ISO
  14971), Failure Mode and Effects Analysis, product risk assessments and assessing specific product issues for impact to patient and/or user safety.
• Participate in design reviews for the system as well as review and approve design input/design output artifacts including requirements, design documents, test results, verification and validation reports.
• Develop, coordinate and conduct technical reliability studies and evaluations of engineering design concepts and design of experiments (DOE) constructs.
• Recommend design or test methods and statistical process control procedures for achieving required levels of product reliability.
• Ensure that corrective measures meet acceptable reliability standards.
• Propose changes in design or formulation to improve system and/or process reliability as necessary.
• Determine units and/or batches requiring environmental testing, and specify minimum number of samples to obtain statistically valid data.

• Medical device industry experience
• Quality Engineering experience
• ASQ-CQE, CQA, CBA or equivalent certifications

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.

Seasoned individual contributor. Works independently under limited supervision to determine and develop approach to solutions. Coaches and reviews the work of lower level specialists; may manage projects / processes.

May be responsible for entire projects or processes within job area. Contributes to the completion of work group objectives, through building relationships and consensus to reach agreements on assignments.

Problems and issues faced are difficult, and may require understanding of multiple issues, job areas or specialties. Makes improvements of processes, systems or products to enhance performance of the job area. Analysis provided is in-depth in nature and often provides recommendations on process improvements.

Communicates with senior internal and external customers and vendors. Exchanges information of facts, statuses, ideas and issues to achieve objective, and influence decision‑making.

Provides guidance, coaching and training to other employees within job area. May manage projects, requiring delegation of work and review of others' work product.

Requires a Baccalaureate degree and minimum of 4 years of relevant experience OR Master’s degree with a minimum of 2 years relevant experience OR PhD with 0 years relevant experience.

For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.

The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to…