Certification and Test Specialist

Company: Agiliti
Location: Milwaukee
Posted on: August 7, 2022

Job Description:

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 RESPONSIBILITIES

• 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 roadblocks.
• Continuously improve the process by making recommendations for change.
• Maintain consistent messaging throughout including professional communication deliverables.
• 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 objectives.
  • Strong interpersonal communication and presentation skills.
  • 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 current.
    • 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 recruiting@agilitihealth.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 v2

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