Epocal, part of Siemens Healthineers, is a leading manufacturer of a clinical Point of Care (POC) diagnostic product. The epoc© Blood Analysis System is healthcare’s first cost-effective POC testing solution to leverage Smartcard Technology and wireless communication to provide caregivers with real-time, lab-quality blood gas, electrolyte, and metabolite results at the patient bedside. This system is now a well-established tool of the medical profession available worldwide. Epocal is committed to delivering high-quality products and services that patients and providers can rely on for consistently accurate and actionable information. We deploy unique innovative technologies that not only transform diagnostic products, but also expand into new platforms and solutions with proven health and economic outcomes.
Epocal was acquired by Siemens Healthineers in October 2017. As a leading global healthcare company, we at Siemens Healthineers develop innovations that support better patient outcomes with greater efficiencies, giving providers the confidence, they need to meet the clinical, operational, and financial challenges of a changing healthcare landscape. As a leader in medical imaging, laboratory diagnostics, and healthcare information technology, we have a keen understanding of the entire patient care continuum – from prevention and early detection to diagnosis and treatment.
For more than 100 years, Siemens Healthineers in Canada has helped healthcare providers achieve their goal of improving outcomes while reducing costs. From the Atlantic to Pacific oceans, more than 450 employees in Canada work together to deliver solutions for healthcare providers, resulting in 70% of medical decisions being influenced by the technologies we provide.
More information is available at: www.siemens-healthineers.ca
Epocal is currently seeking a Risk Manager to support its mission as a manufacturer of Point-of-Care in vitro diagnostic devices and new product development. As Risk Manager, you will be embedded in one or more device development teams and/or Change Control Board and you will ensure these activities meet and are documented according to ISO14971. You will support regulatory medical device reporting requirements for agencies such as FDA and European Competent Authorities.
Duties and Responsibilities
Ensure Quality Risk Management Files are in alignment with 21CFR Part 820 design control and risk management requirements of ISO 14971
Conduct risk assessments and create/revise risk management documents as required by Standard Operating Procedures, FDA, EU and other medical device regulations.
Create, update and curate the Risk Management File for consistency across projects, teams and sites
Lead periodic and event driven risk reviews of the Risk Management Files for commercialized products
Present project-specific risk management activities at regulatory body inspections and internal audits
Support the medical safety teams with assessment and responses to regulatory agencies and competent authorities related to medical device reporting requirements
Plan, prepare and perform risk management for medical devices according to project phases following all relevant internal procedures, processes and external requirements for development products
Work with engineers and scientists to assess design changes from systems perspective, identifying risks, driving design mitigation's and evaluating effectiveness of the risk control measures; monitor that these risk controls are implemented, verified and validated
Manage hazard analyses, design risk assessments, use risk assessments, system risk assessments, and process risk assessments for new products and new accessories
Support creation of device design specifications to ensure that risk control measures are appropriate
Maintain a close link to the human factors engineering process to meet the needs and ensure the safety of all users and patients
Collaborate with development and change management teams to assess risk (design/user/system/process) medical devices and accessories designed and manufactured at Epocal
Partner with the complaints and safety teams to support life cycle management
Partner with other Siemens entity to ensure alignment of risk management practices across in vitro diagnostics devices
Communicate with RM team members on other projects to share lessons learned and ensure use of common tools and ideas within the team
Skills & Qualifications (Education and Experience)
Minimum of Bachelor’s degree or equivalent in science or engineering or similar field
At least 5 years relevant experience in risk management for medical devices
Very good knowledge of international medical standards, e.g.:ISO 14971 ISO 13485 IEC 62366-1
Very good knowledge of and experience in performing risk management for medical devices
Good knowledge of usability engineering or human factors engineering for medical devices
Proficient in usage of risk assessment methods, e.g.:Fault Tree Analysis (FTA), Failure Modes and Effects Analysis (FMEA), Preliminary Hazard Analysis (PHA), Risk management process according to ISO 14971
Working knowledge of DOORs requirements management software is a plus
Soft Skills to succeed in our organization
Flexibility in approach and ability to adapt to changing circumstances when required
Highly self-responsible, goal-oriented and proactive, and ability to complete projects and meet deadlines
Equally at ease with system’s view to problem solving and with good attention to details
Strong interpersonal skills and sensitivity, successfully influence outcomes, communicate with all levels of the organization
Excellent team player, decision making and problem-solving
Organization: Siemens Healthineers
Company: EPOCAL INC.
Experience Level: Experienced Professional
Job Type: Full-time
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