Test & Reliability Engineer

Test & Reliability Engineer

Job Description

Hybrid

Description:

This engineer works within or on the test and reliability team and/or a project team, generally within the molecular R&D project group. This engineer will use experience and education to test and evaluate electromechanical medical devices to identify product limits and to identify and evaluate improvements throughout the products lifecycle. This engineer uses experience and education to perform the types of engineering activities which are generally considered within the realm of test and reliability engineering and any other expertise that might be held by this particular individual. This engineer is expected to work and communicate well with other team members and leadership as assigned in order to meet the goals of the project, the department, and the company.

Principal Job Duties and Responsibilities include but are not limited to the following:

1. Perform all work in compliance with company policy and within the guidelines of the client Quality System.
2. General: uses experience and education to perform the types of engineering activities which are generally considered within the realm of test and reliability engineering.
3. Description: Uses engineering concepts, company SOPs/WIDs, department SOPs/WIDs to solve a variety of difficult engineering problems across functional groups and disciplines.
4. Works on: problems of moderate scope and complexity. Generally works on a team with other engineers.
5. Influence: receives some oversight from a Senior/Principal Engineer and/or Manager, eligible to be a discipline lead on a project.
6. Makes design and technical decisions subject to review by Senior, Principal, and other engineers.
7. Perform Root cause analysis on failures observed during testing.
8. Participate in and conduct Engineering product design reviews and investigations
9. Responsible for development of testing for electromechanical medical device throughout its product life cycle, including:
a. Environmental testing (Temperature, Humidity, Altitude)
b. Shock and vibration testing
c. Reliability testing
d. Ship testing
e. Dust ingress
f. Water ingress
g. Electrical/EMC/EMI
10. Developing Test Fixture Designs.
11. Develop and maintain test protocols and test plans throughout the development cycle (utilizing Helix ALM) for electrical and mechanical sub level testing and electromechanical system level testing.
a. Design Verification Testing
b. Design Validation Testing.
12. Performs other duties as assigned.

Qualifications:
13. B.S. in Engineering or Equivalent.
14. 10+ years of experience in an engineering field, testing field preferred.

1. Travel: minimal travel required.
2. Team: usually works on a team with several engineers and a project manager.

Experience, Knowledge, Skills, and Abilities
Experience with the following is preferred:

Strong Analytical Skills

FDA Regulated Industry

MIL-STD-810

Design Verification/Validation Testing

Test Protocol Development

Proficient in test method/fixture development and execution for electromechanical devices:
o Environmental testing (Temperature, Humidity, Altitude)
o Shock and vibration testing
o Reliability testing
o Ship testing
o Dust ingress
o Water ingress
o Electrical/EMC/EMI

Root cause analysis (mechanical and electrical)

Solidworks

Design Controls

Excellent testing and “hands on” development aptitude

Experience designing, writing and analyzing engineering studies, and investigations

Developing life cycle tests and accelerated life testing

Ability to work effectively both in a team setting and individually

Statistics:
o Minitab experience
o Knowledge of Reliability demonstration test plans
o Hypothesis Testing
o Gage R and R
o Designing and Analyzing DOE’s

HALT test fixture development and analysis


Ability to adjust or move objects up to 50 pounds in all directions.

? Domestic travel required < 10 % of time
? International travel required < 10% of time

VIVA is an equal opportunity employer. All qualified applicants have an equal opportunity for placement, and all employees have an equal opportunity to develop on the job. This means that VIVA will not discriminate against any employee or qualified applicant on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status