Sr Reliability Engineer - St Paul, United States - LanceSoft

Description

Must Have:
advanced data analysis
Database
Data presentation
data reporting
Statistics


Nice to Have:
complaints management
Complaint Trending
Medical device industry experience
Quality Assurance
risk management for medical devices


JOB DESCRIPTION
Additional detail from the hiring manager: please note that the alternate job title for this request is "Sr. Complaint Trending Engineer."
Can you please confirm your top 3 skills sets required?
Data analysis
Use of databases and obtaining data from a databases
Basic understanding of medical device complaints

Note:
previous experience in the medical device industry is highly preferred
Can you please confirm the 3 main responsibilities/day to day activities required for this role?
Create complaint trending reports based on a defined plan.
Identifies and assesses complaint monitor threshold breaches to identify trends and themes.
Collaborates with Product Performance Engineers to disposition complaint threshold breaches and determine whether additional investigation or actions are necessary.
What products (if any) will this role support? CAS products (cardiac ablation and mapping)
What is your target years of experience? 4
When do you plan to start interviewing? April 24th
Will you be looking to hire and start ASAP or will the start date be delayed? ASAP
Will the contingent worker be working remotely or onsite, or both (if both, please confirm possible schedule)? 3 days a week on site

Responsibilities may include the following and other duties may be assigned. Develops, coordinates and conducts technical reliability studies and evaluations of engineering design concepts and design of experiments (DOE) constructs. Recommends design or test methods and statistical process control procedures for achieving required levels of product reliability. Completes risk analysis studies of new design and processes. Compiles and analyzes performance reports and process control statistics; investigates and analyzes relevant variables potentially affecting product and processes. Ensures that corrective measures meet acceptable reliability standards. Analyzes preliminary plans and develops reliability engineering programs to achieve company, customer and governmental agency reliability objectives. May develop mathematical models to identify units, batches or processes posing excessive failure risks. As necessary, proposes changes in design or formulation to improve system and/or process reliability. May determine units and/or batches requiring environmental testing, and specifies minimum number of samples to obtain statistically valid data.


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:
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.


Organizational Impact:
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.


Innovation and Complexity:
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 indepth in nature and often provides recommendations on process improvements.


Communication and Influence:
Communicates with senior internal and external customers and vendors. Exchange information of facts, statuses, ideas and issues to achieve objective, and influence decisionmaking.


Leadership and Talent Management:
May provide guidance, coaching and training to other employees within job area. May manage projects, requiring delegation of work and review of others' work product .


Required Knowledge and Experience:
Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience. May have practical knowledge of project management.

Requires a University Degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.

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