About Cerus:
Cerus aims to be the global leader and trusted partner of blood centers and hospitals whose technology, services, and commitment are the lifeblood of safe and accessible blood for patients around the world.
Primary Responsibilities:
- Manage the planning and coordination of medical device design and development activities across internal teams, external teams, and vendors
- Lead and support manufacturing activities for commercial medical devices
- Engage and collaborate with cross-functional teams to gather and define product requirements, define high-level design, evaluate technical concepts, and contribute to technical decisions
- Act as a software subject matter expert within project teams
- Define and maintain software development lifecycle processes and instructions per IEC 62304 and other relevant regulatory guidelines and standards
- Define and maintain software development environments and supporting tools
- Design, setup, and conduct experiments to characterize the performance of technical solutions
- Support in-vitro studies and early-stage clinical trials for new products
- Prepare clear and concise technical reports and documentation in accordance with quality system requirements
- Stay current with relevant developments in academia and industry through literature review and training
Qualifications/Requirements/Skills:
- Bachelor of Science or higher degree in a related field, including Computer Science, Computer Engineering, Electrical Engineering, or similar
- Minimum 5 years of relevant (non-internship) experience in leading teams through development activities
- Minimum 5 years of relevant (non-internship) software development experience per IEC 62304
- Experience managing and leading projects across distributed internal and external teams with a proven track record
- Experience with medical device development, including a thorough understanding of and familiarity with 21 CFR Part 820, EU MDR, and ISO 13485 guidelines and standards
- Experience throughout the product development lifecycle
- Experience with developing and sustaining embedded devices
- Excellent problem-solving skills with a preference to be hands-on
- Excellent verbal and written communication skills
- Experience in product software development in an object-oriented programming language (e.g., C++)
- Preferred experience defining, implementing, and deploying cybersecurity strategies and supporting processes to relevant regulatory standards, including FDA guidance on medical device cybersecurity
- Results driven and highly motivated self-starter that can work independently with minimal supervision
- Flexible with the ability to manage simultaneous tasks and adapt to changing priorities
- Domestic and international travel required (<20%)
We understand that our people are essential to our success. This philosophy is revealed in our competitive benefits package, designed to improve employees’ lives both on and off the job.
Benefits plans: medical, dental, vision, domestic partner benefits, paid maternity and paternity leaves, healthcare and dependent care flexible spending, life and accidental death insurance, long-term and short-term disability insurance, matching 401(k), ESPP, RSUs
Work and family: EAP, legal and financial services, health club membership discounts, tuition reimbursement
Compensation: The base salary range for this position in the San Francisco Bay Area: $166,000-$190,000 annually
Compensation may vary outside of this range depending on various factors, including a candidate’s qualifications, skills, competencies, experience, and location. Base pay is one part of the total package to compensate and recognize employees for their work.
All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or on the basis of disability.
What We Do
Cerus Corporation is dedicated solely to safeguarding the world’s blood supply and aims to become the preeminent global blood products company. Headquartered in Concord, California, the company develops and supplies vital technologies and pathogen-protected blood components to blood centers, hospitals, and ultimately patients who rely on safe blood. The INTERCEPT Blood System for platelets and plasma is available globally and remains the only pathogen reduction system with both CE mark and FDA approval for these two blood components. The INTERCEPT red blood cell system is under regulatory review in Europe, and in late-stage clinical development in the US. Also in the US, the INTERCEPT Blood System for Cryoprecipitation is approved for production of INTERCEPT Fibrinogen Complex, a therapeutic product for the treatment and control of bleeding, including massive hemorrhage, associated with fibrinogen deficiency. For more information about Cerus, visit www.cerus.com and follow us on LinkedIn.