What are the responsibilities and job description for the Reliability Engineer II position at ATR International?
Job Title : Reliability Engineer II
Type : Contract - 8 Months
Location : 880 Technology Park Drive, Billerica, MA
Pay : Can Be Flexible
We are seeking a Reliability Engineer II for a very important client.
Perform design verification activities including test method development, sample size rationale, and product acquisitions to support all products (as needed).
Perform test method validation activities using appropriate statistical methodologies.
Perform reliability activities to resolve product related issues (manufacturing, field complaints, etc.)
Apply critical thinking to determine the need for further actions or to document audit defendable rationales when no further actions are required.
Update Risk Management files (Risk Management Report, Product Hazard Analysis
Responsibilities may include the following and other duties may be assigned. Perform reliability activities to resolve product related issues (manufacturing, field complaints, etc.). 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.
The ideal candidate must possess the following qualifications :
TECHNICAL SKILLS
Must Have
Bachelor’s degree in Engineering, Science, or a related technical discipline
Reliability Testing, Design Verification, and / or Test Method Validation
Nice To Have
1-3 years of Medical Device industry experience, Familiar with FDA 21 CFR Part 820, EU 217 / 745 (EU MDR),
- Familiar with these standards : ISO 13485, ISO 14971, IEC 60601, Knowledge of Microsoft Office Applications (Word, Excel, Access, and PowerPoint) and Windows OS, and Strong written and verbal communication skills and ability to work cooperatively as part of a cross-functional team.
Top 3 technical skills that are required for the role :
Reliability Engineering
Test Method Development
Test Method Validation
Education Required : Bachelor’s degree in Engineering, Science, or a related technical discipline.
Years’ Experience Required : 2-4 yrs
Benefits include :
