Sr Systems Engineer

SUMMARY
The Senior Systems Engineer leads a technical program to analyze, design, and develop the next generation of robotic digital 3D surical microscopes. The Senior Systems Engineer will be responsible for helping shape future products as well as supporting existing products. They will perform analysis and modeling to support their concepts, and to verify their designs will meet requirements. The Senior Systems Engineer should be comfortable with requirements, documentation, and testing, and be able to create or contribute to design documents including Workflow Definition, DFMEA, Risk Analysis, and architecture

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
• Conduct technical proof of concepts of emerging medical technologies, to develop and refine the next generation of products.
• Lead the system architectural development of next generation highly technical medical products, including electrical, optical, mechanical, industrial design, and software development and integration.
• Create system level documentation to organize architectures, create strategies, and mitigate risk.
• Develop system level requirements to cover all aspects of system performance.
• Work jointly with regulatory affairs to prepare test results and submission to regulatory organization worldwide, including compliance with MDR and FDA.
• Own and maintain the traceability between system requirements and verification testing via Inputs Outputs Verification Validation (IOVV) matrix
• Own and maintain the system Risk Management File (RMF) via cross functional risk analysis, including essential performance
• Work closely with product management to understand/translate voice of customer. Participate in developing the voice of customer, including attending conferences, operating rooms and labs, and analysis of competitors product offerings and system configurations
• Coordinate technical design reviews with all levels of the organization.
• 60601-1 subject matter expert for technical peer reviews
• Coordinate external testing with certified labs
• Review system verification plan and system verification procedures

COMPETENCIES
To perform the job successfully, an individual should demonstrate the following competencies:

Complexity – Works on problems of basic scope where analysis of situations or data requires a review of a variety of factors. Exercises judgment within very defined procedures and practices to determine appropriate action. Builds productive internal/external working relationships.

Knowledge – Developing professional expertise, applies company policies and procedures to resolve a variety of issues.

Teamwork - Balances team and individual responsibilities; Exhibits objectivity and openness to others’ views; Gives and welcomes feedback; Contributes to building a positive team spirit; Able to build morale and group commitments to goal and objectives; Supports everyone’s efforts to succeed; Recognizes accomplishments to other team members

Supervision - Normally receives instruction on day-to-day work, general instructions on new assignments.

Leadership - Given an introduction to the context in which a task fits, can design and complete a small to medium sized task independently

QUALIFICATIONS
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Education/Experience
Typically requires a Bachelor’s degree and a minimum of 3-5 years of related experience; or an advanced degree without experience; or equivalent work experience.

Language
Ability to read, analyze, and interpret professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public. Knowledge of the structure and content of the English language including the meaning and spelling of words, rules of composition, and grammar.

Additional Skills
• Expertise in medical imaging and/or scientific imaging technologies
• Expertise in medical device development
• Experience with optical concepts, optical design and camera technology
• Experience with measurement automation
• Experience shepharding product through regulatory and/or EMC testing
• Broad knowledge of engineering concepts (EE, ME, SW, data analysis, modeling)
• Microsoft Word, Excel and Outlook or equivalent

PHYSICAL REQUIREMENTS
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this Job, the employee is regularly required to sit; use hands to finger, handle, or feel; reach with hands and arms and talk or hear. Specific vision abilities required by this job include color, stereoscopic and close vision. The employee is occasionally required to stand; walk and stoop, kneel, crouch, or crawl.

WORK ENVIRONMENT
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is frequently exposed to computer systems and electrical devices. The noise level in the work environment is usually low to moderate.

Base Salary: 150k - 180k (plus bonus)