The Cardiac Management Solutions division of ZOLL Medical Corporation develops products to protect and manage cardiac patients, including the LifeVest® wearable cardioverter defibrillator (WCD), the ZOLL cardiac monitor, and associated technologies.

Heart disease is the leading cause of death for both men and women in the U.S. At ZOLL, your work will help to ensure cardiac patients get the life-saving therapy they need. To date, the LifeVest WCD has been worn by hundreds of thousands of patients and saved thousands of lives.

ZOLL has been Pittsburgh’s Manufacturer of the Year, one of Western PA’s Healthiest Employers, and even one of Pittsburgh’s Coolest Offices. But it’s our unique opportunity to impact people’s lives that makes ZOLL the ideal place to build your career.

Job purpose

This position will serve as the subject matter expert on risk management within our quality management systems and will support risk management collaboration throughout the project team and organization This position will be responsible for the maintenance of risk management quality documentation. Daily tasks for this role will be based around risk management documentation, risk analysis, failure mode effects and analysis, authoring risk controls and traceability mapping for identified risk controls including their verification of effectiveness, risk-based V&V methodology and objective evidence, residual risk review and risk benefit analysis
Duties and responsibilities

• Maintain the risk management process including Risk Identification, Risk Analysis, Risk Mitigation, Risk Monitoring and Risk Reduction.
• Support Risk Management activities for assigned projects and establish system risk documentation including the Risk Management Plan, Risk Management Report, Post Market Risk Evaluation etc.
• Coordinate across functional teams in the development & execution of design risk analyses for Design Plans, Design Reviews, Change Orders and dFMEA, pFMEA and uFMEA, and product risk assessment documentation
• Advise R&D personnel on risk management activities throughout the product lifecycle, including those associated with corrective and preventive actions (CAPA). This includes risk management plans and reports, hazard analysis, design and process risk assessment
• Collaborate with Medical Affairs on determination of severity of harms and benefit/risk analyses, and for input to clinical evaluations.
• Perform risk assessment as part of post-market surveillance in support of complaint risk analysis, field corrective actions, design changes, product life cycle sustaining efforts, and supplier risk assessment evaluation and manufacturing non-conforming materials
• Identify potential continuous improvement efforts by collaborating with cross functional teams
• Keep abreast of emerging regulatory/industry trends regarding risk management

Qualifications

• Must have a Bachelor's degree in a technical or engineering discipline
• 1-3 years of risk management design controls, systems engineering, or quality assurance experience preferred in the Medical Device Industry

• Knowledge of 21 CFR 820, ISO 13485 and ISO 14971 requirements for Class II and Class III medical device is a plus
• Working knowledge of US FDA regulations for Class II and Class III medical devices is a plus
• Cross functional team experience is a plus

Skills

• Project Management skills preferred
• Must be able to work under pressure to meet regulatory reporting time frames and company requirements
• Knowledge of U.S. and European/International regulations and standards
• Must work well in team environments
• Proven analytical abilities, able to apply problem-solving skills for problems of moderate to diverse scope
• Understanding of manufacturing, change control and risk management, and an awareness of regulatory trends
• Understanding of engineering concepts and scientific terminology
• Experience reviewing technical and design specifications is a plus
• Superior interpersonal skills
• Excellent communication skills, both oral and written
• Documented evidence of writing skills

Working conditions

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

The noise level in the work environment is usually quiet.

Physical requirements

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this Job, the employee is regularly required to sit and talk or hear. The employee is occasionally required to stand; walk and reach with hands and arms. The employee must occasionally lift and/or move up to 25 pounds.

Supervisory responsibility

NA

AAP/EEO Statement

ZOLL is committed to fostering an inclusive workplace, where unique identities, backgrounds, cultures, perspectives and experiences are respected and valued.

Equal Opportunity Employer – Disability and Veteran

ZOLL now mandates COVID vaccinations subject to legal exemptions.

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