Senior Systems Engineer

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.

Summary

This Senior Systems Engineer will be part of the System Development team focusing on the development of novel In Vitro Diagnostics (IVD) automated systems and end-to-end product solutions. The individual is expected to provide technical and process expertise in collaboration with internal stakeholders and cross functional teams throughout the total product development lifecycle to develop and maintain medical device products, according to customer requirements, applicable regulatory and quality standards. This role is expected to lead and mentor less experienced engineers and their career development.

This position is based in Santa Clara, on site.

The Opportunity

This position is responsible for, but not limited to, the following:

• Provide technical expertise to cross-functional teams to develop IVD systems and ensure the product design will meet customer requirements as well as applicable standards and regulations;

• Develop and manage systems level product requirements;

• Perform product risk management activities;

• Develop and execute verification/validation activities and traceability analysis;

• Create artifacts required for project deliverables;

• Resolve issues found according to company's defect/change tracking process;

• Maintain knowledge of current regulatory requirements and standards as they pertain to the development and testing of medical/IVD devices;

• Maintain compliance as required by regulatory bodies and the company's quality system;

• Collaborate with cross functional teams to identify opportunities for continuous process improvement;

• Lead and mentor less experienced Systems Engineers;

• Support U.S. Food and Drug Administration (FDA) and other regulatory submission and audits;

Who you are

You're someone who wants to influence your own development. You're looking for a company where you have the opportunity to pursue your interests across functions and geographies.

Where a job title is not considered the final definition of who you are, but the starting point.

Qualifications (Required)

• Bachelor's degree in Systems Engineering, Biomedical Engineering, Electrical Engineering or related disciplines. Advanced degree preferred.

• 5+ years of professional experience in medical device industry. Experience in IVD industry highly desirable.

• Hands-on experience with liquid pipetting systems such as Hamilton, Tecan etc. is a plus.

• Experience developing product requirements and design inputs.

• Experience conducting risk management activities per ISO 1497.

• Strong analytical, problem solving, communication, and interpersonal skills.

Relocation benefits are not available for this job posting.

The expected salary range for this position based on the primary location of California is $83,900.00 and $125,000.00. 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.

If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.