Principal Engineer, Computational Software Risk Management

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.

A healthier future. It's what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That's what makes us Roche.

As a Principal Engineer of Computational Software Risk Management you will work with a highly collaborative team of imaging scientists, product managers, algorithm developers & test engineers to build imaging and data analysis algorithms and solutions in the field of Digital Pathology. You will be a risk management expert leading the computational software risk management for digital pathology solutions, including image processing algorithms, pattern recognition and integration with platform software for Roche Digital Pathology products.

The Opportunity:

• Facilitate and oversee comprehensive risk assessments to identify and mitigate potential software risks effectively.

• Collaborate with multi-disciplinary project team members to produce and maintain world-class risk files in compliance with ISO 62304 and ISO 14971 standards.

• Align team processes and practices with ISO 24971:2020 standards, driving adherence to industry benchmarks.

• Own and maintain detailed product risk files, ensuring they reflect current risk assessments and mitigation strategies.

• Champion a risk-based approach to defect resolution, prioritizing issues based on impact and risk severity.

• Partner with the product definition, development and Verification & Validation teams to design and implement risk-based implementation & testing methodologies.

• Provide expert inputs for authoring regulatory submissions, and actively participate in reviews and audits to ensure compliance and accuracy.

Who You Are:

• 10+ years of experience with risk management within the regulated industry (preferably in medical devices) and with at least 5 years of direct experience in risk assessment, documentation, and mitigation processes.

• Bachelor's Degree or equivalent combination of education and work experience.

• Deep understanding of Quality Management Systems (QMS) and regulations & standards like IVDR, 21 CFR 820, ISO 14971, ISO 24971 and ISO 27001.

• Extensive knowledge of standalone software regulations, design, development, and auditable artifacts, aligned with ISO 15288, IEC 62304, and IEC 82304.

• Working knowledge of cloud platforms such as AWS and GCP, with an understanding of associated risks, security, and privacy issues.

• Proven experience in developing solutions that comply with data privacy and security standards, such as NIST, HIPAA, GDPR, and ISO 27k.

Relocation benefits are not available for this job posting.

For a strong non local candidate, we are open to this being a remote-based opportunity.

The expected salary range for this position based on the primary location of California is $162,600 - $302,000 of hiring range. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.

Benefits

A healthier future drives us to innovate. Together, more than 100'000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.

Let's build a healthier future, together.

Roche is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.

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