SUMMARY
The Staff Systems Engineer is responsible for helping shape future products as well as executing in the support of existing products. Ideally they have Systems Engineering experience with complex electro-mechanical systems and surgical navigation. Perform analysis and modeling to support their concepts, and to verify their designs will meet requirements. The Staff Systems Engineer is a subject matter expert in medical device development. This includes requirements, 60601-1 documentation and testing, and be able to create or contribute to design documents including Workflow Definition, DFMEA, Risk Analysis, trace matrices.
SALARY AND PAY TRANSPARENCY
Salary range for this position is between $150,000 and $185,000. Base pay is dependent upon many factors, such as: training, transferable skills, work experience, education, business needs and market demands. The base pay range is subject to change and may be modified in the future. This role may also be eligible for bonus and all applicable company benefits.
The salary range and/or hourly pay rate listed is a good faith determination of potential base compensation that may be offered to a successful applicant for this position at the time of this job posting and may be modified in the future.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
* Lead the system architectural development of next generation highly technical medical products, including electrical, optical, mechanical, industrial design, and software development.
* Create system level documentation to organize architectures, create strategies, and mitigate risk.
* Direct support of the Verification and Validation team
* Owner of Verification and Validation activities per project schedules
* Develop system level requirements and verification/validation tests to cover all aspects of system performance.
* Work with project management to create schedule and cost estimates for project execution.
* Work jointly with regulatory affairs to prepare test results and submission to regulatory organization worldwide, including compliance with MDR and FDA.
* 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
* Conduct technical proof of concepts of emerging medical technologies, to develop and refine the next generation of products.
* 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 notified bodies
* Review system verification plans and system verification procedures
COMPETENCIES
To perform the job successfully, an individual should demonstrate the following competencies:
Complexity - Works on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors. Exercises judgment in selecting methods, techniques, and evaluation criteria for obtaining results. Consults with key resources outside own area of expertise.
Knowledge - Having wide-ranging experience, uses professional concepts and company objectives to resolve complex issues in creative and effective ways.
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 goals and objectives; Supports everyone's efforts to succeed; Recognizes accomplishments to other team members.
Independence - Acts independently to determine methods and procedures on new or special assignments. May supervise the activities of others.
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 minimum of 8 years of related HW/SW/System/Optical experience with a Bachelor's degree; or 6 years and a Master's degree; or a PhD with 3 years experience; or equivalent 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 scientific imaging technologies
* Expertise in medical device development
* Experience with optical concepts, optical design and camera technology
* Experience with measurement automation
* Experience shepherding product through 60601-1 / EMC testing
* Working knowledge of Scrum or other Agile development methodologies
* Broad knowledge of engineering concepts (EE, ME, SW, data analysis, modeling)
