Staff Systems Engineer

Job Description

ABOUT US

True Digital Surgery, a B. Braun company, is a World Leader in Computer-Guided Microsurgery. We combine 3D visualization and guidance software applications focused on improving accuracy, efficiency and outcomes for surgeons and patients. Our medical imaging and guidance system employs advanced real-time 3D graphic capabilities and proprietary software that is sold to surgeons and hospitals all over the world.

SUMMARY

The Staff Systems Engineer is responsible for helping shape future products as well as executing in the support of existing products. They will perform analysis and modeling to support their concepts, and verify their designs will meet requirements. The Staff Systems Engineer is a subject matter expert in medical device development requirements, 60601-1 documentation and testing, and be able to create or contribute to design documents including Workflow Definition, DFMEA, Risk Analysis, IOVV.

SALARY AND PAY TRANSPARENCY

Salary range for this position is between $135,000 and $175,000. 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 & RESPONSIBILITIES

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

Create system level documentation to organize architectures, create strategies, and mitigate risk

Direct supervisor 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

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 notified bodies

Review system verification plan and system verification proceduresRequired Skills and Experience

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)

Microsoft Word, Excel and Outlook or equivalent

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 accommodation 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 public. Knowledge of the structure and content of the English language including the meaning and spelling of words, rules of composition, and grammar.

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. Networks with key contacts 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. Some barriers to entry exist at this level (e.g., dept/peer review). Level at which career may plateau.

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 - Acts independently to determine methods and procedures on new or special assignments. May supervise the activities of others.

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. The employee must occasionally lift and/or move up to 50 pounds and frequently lift and/or move up to 20 pounds. Specific vision abilities required by this job include color, distance and close vision.

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 work near moving mechanical parts. The noise level in the work environment is usually moderate.

Benefits:

We value our employees’ time and efforts. Our commitment to your success is enhanced by our competitive compensation and an extensive benefits package including paid time off, medical, dental and vision benefits and future growth opportunities within the company. Plus, we work to maintain the best possible environment

To Apply:

To respond to this opportunity, please apply through this ad.

For more information about us, please visit

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

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