Device Engineer I / II

Primary Responsibilities:

• Support design and development of new medical device technologies and solutions through prototyping, experimentation, modeling, and analysis
• Support sustaining activities for commercial medical devices through technical investigations and change controls
• Support manufacturing equipment development and verification (IQ/OQ/PQ) for medical device production
• Support in-vitro studies and early-stage clinical trials for new products
• Design, setup, and conduct laboratory experiments to characterize the performance of new technical solutions and interactions with biologics and chemistry
• Engage and collaborate with cross-functional teams to gather requirements, evaluate technical concepts, and contribute to technical decisions
• Document, integrate, trace, analyze, and manage requirements, risks, and test protocols using appropriate management tools and processes
• Plan and coordinate system integrations, verifications, and design transfers across external development teams
• Provide technical guidance to project teams to accomplish tasks and achieve company objectives
• Stay current with relevant developments in academia and industry through literature review and training
• Prepare clear and concise technical reports and documentation in accordance with quality system

Qualifications/Requirements/Skills:

• Bachelor of Science or higher degree in Software, Electrical, Mechanical, Optical Engineering or equivalent.
• Recent new graduates with no experience would be eligible for level I Engineer. 
• Two years of relevant product development experience, including software development and testing experience per IEC 62304 would be eligible for level II Engineer. 
• Good experience throughout the product development lifecycle
• Good experience with developing and sustaining embedded devices
• Good leadership skills with a capability to lead distributed technical teams
• Excellent problem-solving skills with a preference to be hands-on
• Excellent verbal and written communication skills
• Preferred experience and working knowledge of medical device development, including a thorough understanding of and familiarity with 21 CFR 30, MDD, and ISO 13485 guidelines and standards
• 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
• Some 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:

Level I (no experience): $77,000-$97,000 annually.

Level II (2 years experience): $95,000-$115,000 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.