Reliability Engineer II

About the role

This position requires a Bachelor's Degree in Engineering, Science, or a technical field with 1+ years of work experience in Engineering and/or Quality. Must have experience in Reliability Testing, Design Verification, Test Method Validation, and strong written and verbal communication skills.

Responsibilities

• Setup and execution of test methods for Test Method Validation or Design Verification
• Report writing and approval
• Review of design, manufacturing and supplier change orders

Requirements

• Reliability Engineering
• Test Method Development
• Test Method Validation

Qualifications

• Must Have:
• Bachelor's Degree in Engineering, Science or technical field
• 1+ years of work experience in Engineering and/or Quality
• Experience in Reliability Testing, Design Verification, Test Method Validation
• Strong written and verbal communication skills
• Nice To Have:
• 1+ years of Medical Device industry experience
• Familiar with FDA 21 CFR Part 820, EU 217/745 (EU MDR)
• Familiar with ISO 13485, ISO 14971, IEC 60601
• Knowledge of Client Office Applications (Word, Excel, Access, and PowerPoint) and Windows OS

Products Supported

Affera Disposable products: Sphere-9, Tubing Set, and Extension Cable

Target Years of Experience

2-4 years

Interview Planning

Will be interviewing in March

Start Date

Starts ASAP

Work Arrangement

Onsite

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.

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.
• 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 decision making.
• 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.