Sr. Manager Systems Engineering

 Candidate Details
10+ to 15 years experience
Seniority Level - Director

Minimum Education - Bachelor's Degree
Willingness to Travel - Occasionally
 
Job Description
Please carefully review the position requirements before submitting a potential candidate for consideration.
 
Leader, Systems Engineering will be responsible of creating and maintaining a highly effective Systems Engineering Team that will be responsible for:
• Architecture/ Interface design 
• Setting  technical direction/ creating solution outline for all programs  
• Requirement Creation / Management 
• Reliability Engineering, Failure Analysis, and Root Cause Investigation 
• Leading RTC Board/ Issue tracking
 
As a leader on the R&D Team:
Develops and manages a high performing Systems Engineering organization.
Oversees the development and maintenance of the system architecture (consisting of electronic, mechanical and software subsystems) for all new products.
Ensures timely completion all Systems Engineering deliverables as outline below including schedule creation, management, budgets, and as required communication to core team and upper management:
Creation of designs that meet customer expectations and high-volume manufacturing requirements.
Creation  and maintenance of the system-level and sub-system-level requirements, use cases and related usage, human factors, hazards, risk management, and traceability documents.
Design and system interfaces, including configuration management.
Partner with QA to ensure successful completion of risk management activities.
Synthesize Marketing and Human factors data to identify key design inputs.
Support the deployment and evaluation of integrated systems in pre-clinical and clinical studies.
Leading reliability and root-cause investigation activities.
Provide necessary supporting data for regulatory submissions for product approval.
As required, support design transfer to manufacturing, and support Sustaining engineering and Marketing during post-launch surveillance.
Ensures timely decision making on all technical aspects of the products.
Implements and Communicates strategic technical direction of programs.
Facilitates the development of technical solutions to complex problems.
Ensures professional growth of all associates within the Systems Engineering Team to create and maintain a high-performing team and Systems Engineering competence.
Maintains a strong working relationships with all Stakeholders.
 
REQUIREMENTS:
B.S. in Biomedical Engineering, Physics, Mechanical Engineering, Electrical Engineering, Systems Engineering, or equivalent, MS is preferred. 
Minimum of 10 years relevant experience.
 
KNOWLEDGE, SKILLS AND ABILITIES:
Demonstrated 4 year experience of leading and growing a technical organization
Hands-on Product development experience
Prior experience of leading and managing a cross-functional project team.
Experience over the full product life cycle is required.
Experience leading root cause investigation and solving complex technical problem
Knowledge of international standards applicable to medical devices, including 21CFR Part 820, ISO13485, ISO14971, and IEC60601.
Experience with in vitro development, and with medical devices preferred; experience in FDA-regulated environments is essential.
Familiarity with DOORS, LabVIEW, Rational Quality Manager, and Rational Team Concert is preferred, and Minitab is a plus.
Experience writing product requirements, specifications, test protocols, and test reports.  
Expertise with requirement and specification management for regulated products is essential.
Experience in industrial design and human factors desirable.