Reliability Engineer II

3 weeks ago

Minneapolis, United States LanceSoft Full time

Must Have:
1. Computer literacy in MS Word, Excel PowerPoint
Ability to navigate different software systems and manipulate data
Dynamic team player with good communication skills
Extremely detailed oriented
Organizational and planning skills

Nice to Have:
Document Control Specialist
Experience in medical devices or other highly regulated industry
Good documentation practices experience

JOB DESCRIPTION
Additional position details from the manager below:

Can you please confirm your top 3 skills sets required? Great Communicator ( Email, verbal, cross-functional, written/phone - possibly calling sites to follow-up, etc.), Organized, Fast Learner/Self-Starter, QMS knowledge is a plus ( understanding and experience with Quality in their background). Specifically post-market quality.
What products (if any) will this role support? Supporting the Neuromodulation and Pelvic Health Product portfolios at ***
What is your target years of experience? 1-5 years of experience
When do you plan to start interviewing? As soon as we have a selection of candidates (Target beginning of Sept when manager returns from PTO)
Will you be looking to hire and start ASAP or will the start date be delayed? Start date is not delayed - will plan to hire as soon as the appropriate candidate is identified to fill the role.
Will the contingent worker be working remotely or onsite, or both (if both, please confirm possible schedule)? Onsite to start for training. Then 3-4 days per week onsite thereafter.
As a Reliability Engineer II, you will maintain systems to support Field Corrective Action activities and Product Non-Conformances.
You will work with partners at the Enterprise level to ensure that our documentation is filed according to the plans and in a timely manner.
You will obtain information form our different databases to scope issues in support of Product Holds and Field Actions.
You will also play a key role in activities to ensure conformance to FDA regulations and *** procedures.
You will collaborate with all the Post Market Quality group in providing data to support non conformances product disposition.

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: Established and productive individual contributor. Works independently with general supervision on larger, moderately complex projects / assignments. Organizational Impact: Sets objectives for own job area to meet the objectives of projects and assignments. Contributes to the completion of project milestones . May have some involvement in cross functional assignments. Innovation and Complexity: Problems and issues faced are general, and may require understanding of broader set of issues or other job areas but typically are not complex . Makes adjustments or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area. Communication and Influence: Communicates primarily and frequently with internal contacts . External interactions are less complex or problem solving in nature. Contacts others to share information, status, needs and issues in order to inform, gain input, and support decisionmaking. Leadership and Talent Management: May provide guidance and assistance to entry level professionals and / or employee in Support Career Stream. Required Knowledge and Experience: Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience. Requires a University Degree and minimum of 2 years of relevant experience, or advanced degree with 0 years of experience.

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