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Reliability Engineer II

5 months ago

St Paul, United States LanceSoft Full time

Nice to Have:
1. Experience supporting, coordinating and / or leading projects 2. Remediation experience (DHF, Regulatory compliance, e.g., EU MDR, UKCA) 3. Experience in development of new or existing medical devices 4. Knowledge of industry standards (ISO 13485) and regulations, specifically EU MDR and UKCA
Analytical and Problem Solving Skills
a Reliability Engineer

JOB DESCRIPTION
Additional position detail from the manager below:
Can you please confirm your top 3 skills sets required? See job description details.
Can you please confirm the 3 main responsibilities/day to day activities required for this role? See job description details
What products (if any) will this role support? This role will support products from the Cardiac Rhythm Management group
What is your target years of experience? 1+
When do you plan to start interviewing? Plan to start interviewing within a month
Will you be looking to hire and start ASAP or will the start date be delayed? Delayed start, start dates likely in August (see request dates)
Will the contingent worker be working remotely or onsite, or both (if both, please confirm possible schedule)? Hybrid required, working both in office and remote. Projects that they will be supporting will require them to be in office. The days in office can vary from day to day but per our groups requirements, we need everyone in the office a minimum of 3 days a week.

Required: Bachelor degree in electrical engineering, biomedical engineering or chemical engineering. One or more years' experience in medical device product development or equivalent is required.
•Solid understanding of engineering fundamentals and proven hands-on electronic/mechanical skills. •Demonstrated ability to perform as a contributing member of cross functional teams, including quality, electronic, and mechanical engineers. •Analytical with strong problem-solving abilities and creative resolution skills •Proficient in Microsoft office programs including Excel and Word •Organize and be able to prioritize workload, meet multiple deadlines simultaneously in a fast paced environment •Strong communication skills [oral and written] including listening; and ability to maintain clear project status and interlocks with internal project teams and external test agencies •Strong interpersonal skills: function as a "team player" and work constructively and cooperatively with all team members in the best interests of the program.

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 1 years of relevant experience, or advanced degree with 0 years of experience.