Test Engineer II - Exempt

JOB DESCRIPTION
Additional position details from the manager:
Can you please confirm your top 3 skills sets required? The ones from the job description that are critical: Medical Device testing, Test method Validation and statistical analysis
Designs, develops, and implements mechanical/electrical testing methods, fixtures, and equipment based on user needs.
Performs test method validation and equipment qualifications per current quality procedures.
Compiles data and performs statistical analyses following current quality procedures (DOE, capability analysis, gage R&R, ANOVA, 2-sample t-test, etc).
What is your target years of experience? 2-5 years
When do you plan to start interviewing? As soon as possible
Will you be looking to hire and start ASAP or will the start date be delayed? end of October
Will the contingent worker be working remotely or onsite, or both (if both, please confirm possible schedule)? Expected to be on site, this team is usually in 5 days a week. We can be flexible and allow some work from home but expect them to be available in the lab everyday when tests are being executed.
ESSENTIAL FUNCTIONS:
Designs, develops, and implements mechanical/electrical testing methods, fixtures, and equipment based on user needs.
Performs test method validation and equipment qualifications per current quality procedures.
Performs/oversees testing for component and assembly-level devices throughout all product development phases.
Compiles data and performs statistical analyses following current quality procedures (DOE, capability analysis, gage R&R, ANOVA, 2-sample t-test, etc).
Effectively communicates test plans and results to key stakeholders.
Troubleshoots test failures and proposes efficient and quality-driven solutions.
Develops subject matter expertise of product use conditions and applied stresses to products during entire implant lifecycle.
Supports animal and human cadaver studies to help define clinically accurate use condition requirements for verification testing or to demonstrate that products meet requirements (GLP study).
Provides team leaders with accurate test timeline and cost estimates.
Represents test function in project teams; responsible for entire testing deliverables for projects and reporting to project teams.
SKILLS/QUALIFICATIONS
Strong technical communication skills both verbal and written
Experience in test development or product development in a highly regulated environment
Experience with test fixture design and materials (3D printing and machining)
Experience in engineering environment with cross-functional engineering teams
Experience in using engineering statistical tools/methods such as DOE, Monte Carlo, Minitab, or JMP.
Experience with Creo, Solidworks, or equivalent CAD software
Experience with test method validation (TMV), gage R&R, Equipment IQ/OQ.
Lean sigma or DRM (design for reliability and manufacturability) or design for lean sigma training preferred.
Experience with mechanical test platforms (Instron, and MTS Universal) preferred.
Experience with fatigue testing (LCF and HCF) preferred.
Experience with data acquisition and analysis software such as LabView, MATLAB preferred.
Experience with X-Ray, CT, and MRI image processing software (i.e.,Mimics, 3-Matic, Amira, and 3D Slicer) preferred.


Responsibilities may include the following and other duties may be assigned. Designs, develops, and implements testing methods and equipment. Plans and arranges the labor, schedules, and equipment required for testing and evaluating standard and special devices. Provides test area with parameters for sample testing and specifies tests to be performed. Compiles data and defines changes required in testing equipment, testing procedures, manufacturing processes, or new testing requirements. Responsible for testing all customer samples and for special tests that cannot be performed in the test area. 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.