California, San Francisco
Job Category: Senior Systems Engineer - Medical Devices
Job Id: 1750
Location: Hercules, CA - onsite
Who We Are:
We’re ALTEN Technology USA, an engineering company that provides solutions for engineering, technology, and product development projects. For decades, we’ve been helping our clients develop products that are changing the world, whether that’s by shaping the future of space exploration, saving lives with medical devices that set a new standard of care, or creating the fully autonomous electric taxi of tomorrow. Our team of more than 600 people work across industries including aerospace, medical devices and life sciences, unmanned systems and robotics, automotive OEM and tier 1 suppliers, commercial vehicle, electric vehicles, rail, and more. Our offices across the US have different industry focuses and engage with our clients in different ways, ranging from working on-site at client facilities to performing product development at our delivery centers.
ALTEN Group, our parent company, has been a leader in engineering and information technology for more than 30 years. ALTEN Group operates in 30 countries across Europe, North America, Asia, Africa, and the Middle East and employs more than 36,000 people, 88% of whom are engineers. The company covers the whole development cycle and offers a choice of service levels, from technology consulting to complete project outsourcing.
When you join ALTEN Technology USA, you join a group of people passionate about collaborating to solve some of the world’s most technical engineering challenges. Our success is tied to taking care of our employees by building relationships and providing opportunities for mentorship and career growth. We offer comprehensive benefits for all full-time employees, including medical, dental, and vision insurance; a 401(k) plan with employer matching; paid time off (PTO); paid parental leave; and mentorship to help you take your career to the next level.
Essential Duties and Responsibilities include the following. Other duties may be assigned.
- Provide technical knowledge of system engineering principles and their application to developing cost- effective, reliable, and high-quality systems that satisfy customer needs and business requirements.
- Provide technical leadership to support the development of a sample to result system.
- Reviews and analyzes customer and business requirements and articulates and documents system requirements and functions.
- Generates, analyzes and developing robust architectures, communicating, and coordinating with marketing and cross-functional development teams, and assisting the development team of the balance between development cost, schedule, quality, and performance.
- Participates or leads Cross-Functional Teams in system requirements definition, system functional decomposition and requirements allocation, system architecture definition, system modeling, and requirements traceability and compliance including verification plans and reports.
- Continuous development of skills and technical expertise required in order to support product development initiatives.
- Assist in the adoption and execution of Systems, Reliability, Risk, Usability and Requirements engineering.
- Maintains extensive knowledge of state-of-the-art principles, theories, and practices around all things Systems and Reliability engineering related activities.
- Works with the development teams in identifying and recommends long term tools, standards, and methods to drive continual Systems and Reliability Engineering improvement.
- Conducts and participates in design/project technical reviews.
- Works to ensure quality and continuously promote Right First Time.
- Medical Device background mandatory
- 10+ years’ experience in the engineering/development of complex systems comprised of electromechanical, fluidics and assay/chemistry subsystems.
- BS in Engineering. MS desirable.
The requirements listed below are representative of the knowledge, skills, and/or abilities required.
- Strong focus on results and achieving goals.
- Ability to identify internal customers and use their needs and perspectives in driving decisions and activities.
- Flexible and adaptive to a rapidly changing environment.
- Training in Design for Excellence principals preferred.
- DFSS Green Belt certification is desirable.
- IVD experience, QSR/ISO regulations & standards, risk management (ISO14971) and Usability Engineering (IEC62366) in a regulated environment