US Safety Engineer

4 weeks ago

Middleton, United States Centaur Health Holdings Full time
Job DescriptionJob DescriptionSalary:

Position title: Safety Engineer

Reports to: Head of Product Safety

Position Location: Middleton WI

Position Summary:

Safety Engineers are responsible for the execution of product safety risk management processes and the development of associated documentation and records. This includes supporting processes that identify, investigate, disposition, and resolve nonconforming product and product safety issues in design, production, and post-production processes in compliance with applicable standards and regulations and the requirements of the Quality Management System.

Safety Engineers are also responsible for assisting the identification of any gaps in product risk management process due to changes in applicable standards and regulatory requirements and develop solutions to resolve any such gaps.

Relevant Knowledge and Skill requirements:

Bachelor's degree (or equivalent) in a technical discipline such as Engineering, Biomedical Engineering, Physics, Biology, Chemistry, or Computer Science. Non-technical degrees will be considered with 3-10 years of relevant industry experience. 3-10 years of experience in engineering, quality assurance, or regulatory affairs within the medical device industry (especially products containing software and electro-mechanical components).

Experience with risk identification and analysis tools such as FMEA, FTA, Hazard Analysis.

Experience with medical devices and product safety activities compliant with ISO 14971 is preferred.

Knowledge of risk assessment, complaint handling, adverse event determination and reporting, correction and removal determination and reporting, labeling, and quality management systems.

Good understanding of the product development life cycle and use of lifecycle management tools.

Strong critical thinking, communication, and problem-solving skills.

Ability to work on problems of diverse scope where analysis of a situation or data requires evaluation of multiple and various factors. Ability to work independently on assigned tasks under time constraints.

Key responsibilities

  • Comply with local and global Quality Assurance Procedures.
  • Lead subject matter experts from various domains (Engineering, Product Management, Clinical, etc.) in the identification, analysis, assessment, control, and evaluation of product safety risks.
  • Facilitate engineers’ contributions to safety analysis and safety documentation.
  • Organize and/or participate in product safety risk assessment activities and application of risk analysis methods (various flavors of FMEA, Hazard Analysis, etc.).
  • Responsible for Risk Management File contents (including Risk Management Plans, Risk Evaluation Documents, Risk Management Reports) and proper maintenance of the respective design documentation throughout the lifetime of the assigned products.
  • Assess Complaints from the field and various reports of product nonconformance for new hazards/hazardous situations or impacts to known hazardous situations.


About Leo Cancer Care

One out of five people are afflicted with cancer during their lifetime. However, only 50% of those patients diagnosed for treatment can afford Radiation Therapy. This is primarily due to costs associated with the large size and complexity of current technology.

Current technology requires that the patient be positioned on a tabletop, typically prone (face up) or supine (face down), while a large ring (gantry) rotates around the patient during treatment. Many patients have reported that this type of Radiation Therapy makes them feel vulnerable and detached.

Leo Cancer Care was founded with one clear goal: to bring a more human way to treat cancer and to empower patients by introducing upright patient positioning to the Radiation Therapy community. We do what we do to find a better way. A better way to treat cancer and create a paradigm shift in radiation therapy. We will do this by improving accessibility and cancer care globally, making cancer treatment a more human experience for all.

We are looking for an enthusiastic individual to complement our passionate team with the mission to revolutionize cancer treatment in the role of Technical Writer. You can be part of a world class team and help develop the treatments of tomorrow. Not only will you be driving change for the greater good, but you'll be working on products that span a large field of different disciplines.  

Ways of working

Leo Cancer Care is dedicated to fostering a diverse and inclusive workplace environment. We embrace and celebrate the unique backgrounds, experiences, and perspectives of all individuals. We believe that diversity enriches our organization and strengthens our ability to innovate and excel. Discrimination or harassment of any kind will not be tolerated. We encourage all qualified candidates to apply and join us in our mission to create a respectful and equitable workplace for all. Leo Cancer Care is an equal opportunity employer.

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