Systems Engineer IV
Company:
KARL STORZ Imaging, Inc.
(KSI) Job Code:
13384 Pay Grade:
US-D18 Salary Range:
$125K - $175K Description KARL STORZ SE & Co.
KG based in Tuttlingen, Germany, is a family-owned, global company committed to benefiting humanity by advancing medical technology through innovation and education.
For more than 75 years, KARL STORZ has been dedicated to earning its international reputation as a leader that designs, engineers, manufactures, and markets all its products with an emphasis on visionary design, precision craftsmanship, and clinical effectiveness.
JOB
Summary:
Responsible for product design at system level.
He/she works closely together with product management, project management, development and production in order to design a product that fulfills customer, manufacturing, service, market and regulatory requirements.
Responsible for system requirements and system architecture, reviews sub-system requirements and architectures, and leads system integration efforts, as well as verification reports through the development life cycle.
POSITION FUNCTIONS :
List the essential duties and responsibilities of the position, in order of importance and/or amount of time spent.
o System Design o Derive and maintain ownership of top level system requirements by collaborating with stake holder representatives- Program Management, Manufacturing, Regulatory, Quality Assurance- to understand User Needs o Develop and maintain ownership of system architecture documentation o Ensure that all authors (including the Systems Engineer) of separate design specifications have articulated the specifications in enough detail to design a system that meets all defined and approved product requirements o Perform the necessary tradeoffs (reliability, cost, schedule, manufacturability, etc.
) of various design approaches and select an optimal approach o Develop system design specifications, including subsystems and system variations o Make sure that all components are working seamlessly together as one system o Decompose the system (product) requirements into hardware, software, optical, and mechanical design specifications o Participate in the system risk analysis o Assist in defining Essential Performance o Define network and insulation diagram o Participate in creation of technical system documentation o Track and review the detailed hardware, software, optical, and mechanical design to ensure it meets the objective and requirements identified in the system documents.
o Develop and execute plan for integration and test of product components comprising the system o Review system verification plan and system verification procedures o Work with Compliance Engineer to coordinate external system testing with notified body, e.
g.
T V, UL, etc.
o Ensure traceability between system requirements and verification testing.
Responsible for overall system performance o Manage system configurations (configuration management) o Collaborate with project management in Agile Development activitieso Analyses and Modeling o Perform system analysis and modeling to support tradeoff studies as required.
o Develop means (tests) of analyzing system components to objectively quantify performance.
o Determine methods of communicating the analytical results with the rest of the Engineering staff.
o Determine, where appropriate, empirical methods, to validate analytical models.
If necessary, update the model assumptions and/or empirical methods to correlate the results.
o Document the results of the analyses in technical reports.
o Research and Development o Research and develop new technology for use in future and existing OR1 products.
o Communicate with purchasing and vendors for new processes and capabilities required for new designs.
o Sustaining Support o Provide sustaining support for existing product lines.
This may include analysis of field issues and/or analysis of manufacturing issues.
Recommend, where appropriate, design system changes.
o Documentation of system changes.
o General Engineering o Provide support and technical direction for the generation and maintenance of the system Design Assurance Checks.
o Regular attendance is an essential job function.
o Will spend part of his/her time as a member of continuous improvement teams undertaking projects and seeking ways to improve the quality of products and services.
ADDITIONAL RESPONSIBILITES:
List other important functions that are secondary duties but may be time consuming.
o Quality - all activities associated with this position must be performed with the highest level of quality standards recognizing that the products are used in the medical industry.
o Durability - all activities associated with this position must address the long-term durability of the device and where appropriate must consider the long-term durability.
o Efficacy - all activities associated with this position must consider the devices final application; ergonomics, interaction of the device with the physician, and device operation during usage are all components of efficacyo Performs other related duties as assigned by supervisor KNOWLEDGE, SKILLS, ABILITIES:
What does a person in this position need to be able to do?o Knowledge of medical device quality system regulations and standards (eg, U.
S.
FDA Quality System Regulation 21CFR Part 820, ISO13485, ISO9001)o Communicates well with required project contacts, seeks to communicate and form relationships with non-required contacts.
o Experience with all of the product development life cycle at Karl Storz or similar industry.
o Ability to perform system tradeoff studies.
o Experience with video systemso Knowledgeable of image processing techniqueso Solid understanding of software design methodology and deliverableso Understanding of networks (protocols, topologies, etc.
)o Thorough understanding of microprocessor controlled systemso Broad understanding of analog and digital hardware design.
o General understanding of optical design, optical materials, and coatingso General understanding of mechanical issues including adhesives, sealing techniques and sterilization requirementso Expert level skills in documenting and communicating system design deliverables and drawingso Highly desirable to have medical systems product design experience EDUCATION AND
Experience:
What is the usual educational background and work experience of an individual qualified to perform this job?o BS / Masters / PHD degree in Electrical Engineering, Physics, Electrical Computer Engineering, Computer Science plus 9
years industry experience followed with 5
years in the role of Systems Engineer.
PHYSICAL & MENTAL REQUIREMENTS:
What are the specific physical and mental demands of this position?o Visual acuity sufficient for testingo Ability to sit for extended periods (during meetings and computer work)o Ability to lift video equipmento Ability to connect electrical devices TRAINING REQUIREMENTS:
Safety, regulatory compliance, legal & job specific.
o Injury and Illness Prevention Programo Quality System trainingo Job Specific - In house requirement SUPERVISORY
Responsibilities:
List job titles supervised by this position.
o NoneLEVEL OF SUPERVISION REQUIRED:
How closely is this position supervised day to day? o The department manager develops general goals for the employee at the yearly review cycles, which are derived from the overall company goals.
o Tasks are derived from these general goals by the employee and reviewed and accepted by the department manager.
o Detail peer review of work accomplished is required and scheduled as required INTERFACE:
(Internal/External Customers) List positions, work groups, departments.
o Product management to understand the end user requirementso Project Engineers and Project Managers for system design and tradeoff studieso Manufacturing Engineers for manufacturability issueso Interact with KARL STORZ departments globally #LI - LS1 Pay Transparency 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.
When determining a specific team member's base salary and/or hourly pay rate, several factors will be considered including such things as location, specialty, service line, years of relevant experience, education, professional credentials, internal equity, and the amount budgeted for the role.
Credentialing requirements at KARL STORZ KARL STORZ is committed to maintaining a safe work environment for our employees and customers.
Most field-based roles at KARL STORZ require hospital credentialing/health screens as a condition of employment.
Credentialing can include required vaccinations, health screens & other requirements as outlined by our customers.
During the interview process, we encourage you to ask how credentialing/health screens may impact the role you are seeking and if you require any reasonable accommodations regarding these requirements.
Employee Benefits Program Overview for U.
S.
Locations Medical / Dental / Vision including a state-of-the-art wellness program and pet insurance, too! 3 weeks vacation, 11 holidays plus paid sick time Up to 8 weeks of 100% paid company parental leave 401K retirement savings plan providing a match of 60% of the employee's first 6% contribution Section 125 Flexible Spending Accounts Life, STD, LTD & LTC Insurance We prepay your tuition up to $5,200 per year! - Tuition preimbursement Fitness reimbursement of up to $200 annually Employee referral program of up to $2,000 per hire And much more! Field sales, internships, and part-time employees are not eligible except where required by state law.
Non-employees, including temporary workers and consultants, are not eligible to participate in the KARL STORZ benefits program.
To include, maternal/paternal leave, adoption, and fostering of a child.
KARL STORZ reserves the right to change or modify the employee's job description whether orally or in writing, at any time during the employment relationship.
Additionally, KARL STORZ, through its supervisors, may require an employee to perform duties outside their normal description within the sole discretion of the supervisor.
Employees must comply will all applicable KARL STORZ policies and procedures.
Equal Employment Opportunity & Reasonable Accommodation Statement KARL STORZ is committed to creating an inclusive space where employees are valued for their skills and unique experiences.
To achieve this goal, we are committed to diverse voices, and all applicants will receive consideration without regard to race, color, sex, national origin, disability, veteran status, or any other protected characteristic.
KARL STORZ is also committed to providing reasonable accommodations during our recruitment process.
Should you need assistance or accommodation please email us at email protected .
Notice to Employment Agencies This recruitment assignment is being managed directly by KARL STORZ's Human Resources team.
Human Resources will reach out to our preferred, contracted agency partners in the rare instance additional talent options are required.
Your respect for this process is appreciated.
KARL STORZ does not accept unsolicited Agency resumes.
Resumes received which were unsolicited by the KARL STORZ Human Resources department will be ineligible for referral fees.
Recommended Skills Agile Methodology Business Process Improvement Computer Engineering Configuration Management Electrical Engineering Engineering Estimated Salary: $20 to $28 per hour based on qualifications.
KARL STORZ Imaging, Inc.
(KSI) Job Code:
13384 Pay Grade:
US-D18 Salary Range:
$125K - $175K Description KARL STORZ SE & Co.
KG based in Tuttlingen, Germany, is a family-owned, global company committed to benefiting humanity by advancing medical technology through innovation and education.
For more than 75 years, KARL STORZ has been dedicated to earning its international reputation as a leader that designs, engineers, manufactures, and markets all its products with an emphasis on visionary design, precision craftsmanship, and clinical effectiveness.
JOB
Summary:
Responsible for product design at system level.
He/she works closely together with product management, project management, development and production in order to design a product that fulfills customer, manufacturing, service, market and regulatory requirements.
Responsible for system requirements and system architecture, reviews sub-system requirements and architectures, and leads system integration efforts, as well as verification reports through the development life cycle.
POSITION FUNCTIONS :
List the essential duties and responsibilities of the position, in order of importance and/or amount of time spent.
o System Design o Derive and maintain ownership of top level system requirements by collaborating with stake holder representatives- Program Management, Manufacturing, Regulatory, Quality Assurance- to understand User Needs o Develop and maintain ownership of system architecture documentation o Ensure that all authors (including the Systems Engineer) of separate design specifications have articulated the specifications in enough detail to design a system that meets all defined and approved product requirements o Perform the necessary tradeoffs (reliability, cost, schedule, manufacturability, etc.
) of various design approaches and select an optimal approach o Develop system design specifications, including subsystems and system variations o Make sure that all components are working seamlessly together as one system o Decompose the system (product) requirements into hardware, software, optical, and mechanical design specifications o Participate in the system risk analysis o Assist in defining Essential Performance o Define network and insulation diagram o Participate in creation of technical system documentation o Track and review the detailed hardware, software, optical, and mechanical design to ensure it meets the objective and requirements identified in the system documents.
o Develop and execute plan for integration and test of product components comprising the system o Review system verification plan and system verification procedures o Work with Compliance Engineer to coordinate external system testing with notified body, e.
g.
T V, UL, etc.
o Ensure traceability between system requirements and verification testing.
Responsible for overall system performance o Manage system configurations (configuration management) o Collaborate with project management in Agile Development activitieso Analyses and Modeling o Perform system analysis and modeling to support tradeoff studies as required.
o Develop means (tests) of analyzing system components to objectively quantify performance.
o Determine methods of communicating the analytical results with the rest of the Engineering staff.
o Determine, where appropriate, empirical methods, to validate analytical models.
If necessary, update the model assumptions and/or empirical methods to correlate the results.
o Document the results of the analyses in technical reports.
o Research and Development o Research and develop new technology for use in future and existing OR1 products.
o Communicate with purchasing and vendors for new processes and capabilities required for new designs.
o Sustaining Support o Provide sustaining support for existing product lines.
This may include analysis of field issues and/or analysis of manufacturing issues.
Recommend, where appropriate, design system changes.
o Documentation of system changes.
o General Engineering o Provide support and technical direction for the generation and maintenance of the system Design Assurance Checks.
o Regular attendance is an essential job function.
o Will spend part of his/her time as a member of continuous improvement teams undertaking projects and seeking ways to improve the quality of products and services.
ADDITIONAL RESPONSIBILITES:
List other important functions that are secondary duties but may be time consuming.
o Quality - all activities associated with this position must be performed with the highest level of quality standards recognizing that the products are used in the medical industry.
o Durability - all activities associated with this position must address the long-term durability of the device and where appropriate must consider the long-term durability.
o Efficacy - all activities associated with this position must consider the devices final application; ergonomics, interaction of the device with the physician, and device operation during usage are all components of efficacyo Performs other related duties as assigned by supervisor KNOWLEDGE, SKILLS, ABILITIES:
What does a person in this position need to be able to do?o Knowledge of medical device quality system regulations and standards (eg, U.
S.
FDA Quality System Regulation 21CFR Part 820, ISO13485, ISO9001)o Communicates well with required project contacts, seeks to communicate and form relationships with non-required contacts.
o Experience with all of the product development life cycle at Karl Storz or similar industry.
o Ability to perform system tradeoff studies.
o Experience with video systemso Knowledgeable of image processing techniqueso Solid understanding of software design methodology and deliverableso Understanding of networks (protocols, topologies, etc.
)o Thorough understanding of microprocessor controlled systemso Broad understanding of analog and digital hardware design.
o General understanding of optical design, optical materials, and coatingso General understanding of mechanical issues including adhesives, sealing techniques and sterilization requirementso Expert level skills in documenting and communicating system design deliverables and drawingso Highly desirable to have medical systems product design experience EDUCATION AND
Experience:
What is the usual educational background and work experience of an individual qualified to perform this job?o BS / Masters / PHD degree in Electrical Engineering, Physics, Electrical Computer Engineering, Computer Science plus 9
years industry experience followed with 5
years in the role of Systems Engineer.
PHYSICAL & MENTAL REQUIREMENTS:
What are the specific physical and mental demands of this position?o Visual acuity sufficient for testingo Ability to sit for extended periods (during meetings and computer work)o Ability to lift video equipmento Ability to connect electrical devices TRAINING REQUIREMENTS:
Safety, regulatory compliance, legal & job specific.
o Injury and Illness Prevention Programo Quality System trainingo Job Specific - In house requirement SUPERVISORY
Responsibilities:
List job titles supervised by this position.
o NoneLEVEL OF SUPERVISION REQUIRED:
How closely is this position supervised day to day? o The department manager develops general goals for the employee at the yearly review cycles, which are derived from the overall company goals.
o Tasks are derived from these general goals by the employee and reviewed and accepted by the department manager.
o Detail peer review of work accomplished is required and scheduled as required INTERFACE:
(Internal/External Customers) List positions, work groups, departments.
o Product management to understand the end user requirementso Project Engineers and Project Managers for system design and tradeoff studieso Manufacturing Engineers for manufacturability issueso Interact with KARL STORZ departments globally #LI - LS1 Pay Transparency 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.
When determining a specific team member's base salary and/or hourly pay rate, several factors will be considered including such things as location, specialty, service line, years of relevant experience, education, professional credentials, internal equity, and the amount budgeted for the role.
Credentialing requirements at KARL STORZ KARL STORZ is committed to maintaining a safe work environment for our employees and customers.
Most field-based roles at KARL STORZ require hospital credentialing/health screens as a condition of employment.
Credentialing can include required vaccinations, health screens & other requirements as outlined by our customers.
During the interview process, we encourage you to ask how credentialing/health screens may impact the role you are seeking and if you require any reasonable accommodations regarding these requirements.
Employee Benefits Program Overview for U.
S.
Locations Medical / Dental / Vision including a state-of-the-art wellness program and pet insurance, too! 3 weeks vacation, 11 holidays plus paid sick time Up to 8 weeks of 100% paid company parental leave 401K retirement savings plan providing a match of 60% of the employee's first 6% contribution Section 125 Flexible Spending Accounts Life, STD, LTD & LTC Insurance We prepay your tuition up to $5,200 per year! - Tuition preimbursement Fitness reimbursement of up to $200 annually Employee referral program of up to $2,000 per hire And much more! Field sales, internships, and part-time employees are not eligible except where required by state law.
Non-employees, including temporary workers and consultants, are not eligible to participate in the KARL STORZ benefits program.
To include, maternal/paternal leave, adoption, and fostering of a child.
KARL STORZ reserves the right to change or modify the employee's job description whether orally or in writing, at any time during the employment relationship.
Additionally, KARL STORZ, through its supervisors, may require an employee to perform duties outside their normal description within the sole discretion of the supervisor.
Employees must comply will all applicable KARL STORZ policies and procedures.
Equal Employment Opportunity & Reasonable Accommodation Statement KARL STORZ is committed to creating an inclusive space where employees are valued for their skills and unique experiences.
To achieve this goal, we are committed to diverse voices, and all applicants will receive consideration without regard to race, color, sex, national origin, disability, veteran status, or any other protected characteristic.
KARL STORZ is also committed to providing reasonable accommodations during our recruitment process.
Should you need assistance or accommodation please email us at email protected .
Notice to Employment Agencies This recruitment assignment is being managed directly by KARL STORZ's Human Resources team.
Human Resources will reach out to our preferred, contracted agency partners in the rare instance additional talent options are required.
Your respect for this process is appreciated.
KARL STORZ does not accept unsolicited Agency resumes.
Resumes received which were unsolicited by the KARL STORZ Human Resources department will be ineligible for referral fees.
Recommended Skills Agile Methodology Business Process Improvement Computer Engineering Configuration Management Electrical Engineering Engineering Estimated Salary: $20 to $28 per hour based on qualifications.
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