Certification and Test Specialist
Posted on: August 7, 2022
Job Description: POSITION SUMMARY The Certification & Test
Specialist will work in collaboration with Project Design and
Quality/Regulatory stakeholders, principally creating documentation
deliverables that support the product certification and regulatory
requirements for medical equipment development. This position will
support assigned initiatives from kickoff through successful
implementation including post market support. They will partner
with leaders and teams to drive program initiatives, facilitate
best practices, and support successful achievement of project cost,
financial, schedule and performance goals. PRIMARY DUTIES AND
- Create Certification and Regulatory documentation as required
per IEC 60601 and ISO 13485. Includes Specifications, DFMEA, PFMEA,
Usability Studies, Product Labeling, Instructions for Use, and
Product Test Reports.
- Manage 3rd party test agency (Intertek) relationships during
certification and audit efforts.
- Conduct Clinical Verification studies in conjunction with
Product Strategy Team.
- Support the development of various test and tooling fixtures
related to Certification requirement testing.
- Proactively maintain currency with all relevant Certification
and Regulatory Standards.
- Participate in product certification, risk analysis,
evaluation, and testing efforts; ensuring quality standards.
- Collaborate with Engineering and Quality/Regulatory teams in
population and maintenance of Engineering Document Control
databases (MDR and DHF).
- Proactively identify and escalate issues/risks facing project
teams and work with cross functional management teams to develop
solutions to improve current emergent processes and
- Continuously improve the process by making recommendations for
- Maintain consistent messaging throughout including professional
- This job description in no way states or implies that these are
the only duties to be performed by the employee in this position.
It is not intended to give all details or a step-by-step account of
the way each procedure or task is performed. The incumbent is
expected to perform other duties necessary for the effective
operation of the department. REQUIRED EXPERIENCE
- Technical Bachelor's degree (BS) preferred.
- Prior Certification, Regulatory, or Medical Product development
experience a significant plus.
- Proven versatility as demonstrated by succession in
responsibilities and willingness to scale abilities to complete
- Strong interpersonal communication and presentation
- PMP (Project Management Professional) experience preferred.
REQUIRED SKILLS & ABILITIES
- Analytical Thinking - Capable of understanding a technical
problem or situation and developing effective solutions.
- Strategic Perspective - Needs to keep overall objectives and
strategies in mind, and not be deflected by matters of detail.
- Applying standards - Effective in the application of relevant
industry and process standards to all tasks undertaken.
- Industry Developments - Must take initiative to ensure skills
and specializations are kept up to date in line with industry
developments and ensure that all relevant skill sets are
- Ability to travel up to 25%. It is the policy of Agiliti to
provide equal employment opportunities to all employees and
applicants for employment without regard to race, color, religion,
gender identity, sex, sexual orientation, national origin, age,
physical or mental disability, genetic information, marital status,
status as a veteran, military service, or any other characteristic
protected by applicable federal, state, or local civil rights laws.
In addition, Agiliti will provide reasonable accommodations for
qualified individuals with disabilities. Agiliti strictly prohibits
any form of retaliation against individuals who make good faith
reports of alleged violations of this policy or who cooperate in
Agiliti's investigation of such reports. Affirmative Action Policy
Statements You may be required to obtain certain vaccinations, or
provide proof of current vaccination status, based on customer
and/or company requirements. If vaccination is required, Agiliti
will provide specific directions and cover the expense at a
participating clinic. Please note, this includes the COVID-19
vaccination. Agiliti is an equal opportunity employer and provides
reasonable accommodations to employees and applicants consistent
with state and federal law. If you require assistance with your
application, please contact email@example.com. Primary
Job Location: Milwaukee District Additional Locations (if
applicable): Job Title: Certification and Test Specialist Company:
Agiliti Location City: West Milwaukee Location State: Wisconsin
Keywords: Agiliti, Milwaukee , Certification and Test Specialist, Other , Milwaukee, Wisconsin
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