Sr Manager/Director, Systems Engineering – Medical Device – HW/SW/Optics – Great Team + Work
Position ID: MV-ECW032312
Job Category: Engineering
Type: Full Time, Employee
Minimum Education: Bachelor's Degree
Our Client is the global leader in its Medical Device category. They have built a collegial culture that enables the design and development of state-of-the-art medical equipment while still supporting a positive work-life balance.
The Senior Manager, Systems Engineering is responsible for providing technical group leadership in the design and development of state-of the-art high quality Diagnostic Instruments.
ESSENTIAL FUNCTIONS:
- Manage a group of Systems Engineers in design, implementation, system integration, verification, and validation of medical devices.
- Plan projects, provide technical direction, work with outside research organizations, and coordinate the efforts of systems engineers and technicians in performance of assigned projects.
- Works under minimal direction toward predetermined goals and objectives. Manages resources to meet multiple project needs and objectives.
- Develop existing staff and hire additional well qualified personnel as needed.
- Acts as the technical expert within the function, advising subordinates to resolve technical or operational problems.
- Contribute directly to applied research and system architecture designs through expertise in optics; signal processing, hardware, software, and system engineering.
- Establish design and documentation standard for the group.
- Establish operating policies and procedures for the group.
- Ensure accuracy and completeness of risk assessments. Ensures effective implementation of risk mitigations.
- Ensure that product development processes are being followed by the group members.
- Generate and maintain development schedules.
- Coordinate with other RD groups, Marketing, Manufacturing, Sales and Service to ensure that the new and existing systems will meet the customer requirements.
- Set annual and ongoing goals and objectives for the group members.
- Write and conducts annual appraisals for the group members.
- Maintain currency of, and adhere to applicable GMP and ISO 9001 processes and procedures. Abide by state and federal employment laws.
REQUIREMENTS:
- Bachelors in Engineering, Physics with optics concentration and a minimum of twelve (12) years relevant work experience.
- Masters or Ph.D. degree in one of the above areas would be desirable and substitute for possible lack of work experience
- Ten (10) years of applicable experience in Electrical, Optics, and/or System design with minimum of 5 years as a systems engineer.
- Five (5) years of experience in functional management.
- Experience in image processing, optical systems, and medical device development is desirable.
- Familiar with modern design methodologies and associated tools.
- Experience with system requirements development and performance verification of complex devices.
- Systematic approach to problem solving and issue resolution combined with good understanding of the relevant technologies and their practical applications.
- Strong analytical skills.
- Excellent verbal and written communication skills.
- Experience with 21CFR 820, ISO 13485, and ISO 17971is desirable.
PrincetonOne is an equal employment opportunity employer.
November 4, 2008
• Tags: California Us, Director, Great Team + Work-Life B Job in Oakland, HW, Medical Device, Optics, Sr. Manager, SW, Systems Engineering • Posted in: General