Component Compliance Engineer IV - Military Veterans
at KARL STORZ Endoscopy-America, Inc.
JOB SUMMARY:
Lead component discussions with EEs globally, and play a key role in establishing global standards and processes. Lead multi-functional teams to solve complex vendor-related component issues. Selects, and qualifies components used in the company's technology. Act as technical interface between component/production suppliers and development engineers to improve quality and reliability and to assist in determining new and alternate sources to reduce cost.
ESSENTIAL FUNCTIONS: List the essential duties and responsibilities of the position, in order of importance and/or amount of time spent.
- Components
- Provide leadership and technical support to the department in the form of component recommendations, research, and documentation to enhance quality, manufacturability, reliability, and regulatory requirements.
- Create and maintain global guidelines such as preferred parts, derating, and tolerance analysis.
- Support Electronics Engineers on component analysis, specifications, target costs, and cost reductions.
- Originate and update Engineering Specification sheets.
- Supports and maintains component compliance along with QA and Material compliance teams for new additiona like China RoHS and REACH.
- Provide component definition and entry into the parts library for schematic and PWB design tools.
- Improve End-of Life (EOL) projections during product development for long production life.
- Represent Engineering in regular EOL meetings with Purchasing, Manufacturing, and Quality departments.
- Support Purchasing, Manufacturing, and contract manufacturers to resolve component issues with existing product lines.
- Support Manufacturing, Quality and Engineering for component issues with existing product lines for such as selecting and analyzing potential End-Of-Life (EOL) replacements.
- Evaluates supplier change notification and qualifies changes, as needed.
- Project Development Teams
- Contribute component ideas, constraints, trade-offs, and concerns to the Electronics Engineers.
- Coordinate with Electronics Engineers to analyze new electronic circuitry per component and system specifications and target costs.
- Reduce component and assembly costs by minimizing diversity of similar parts - maximize commonality.
- Reduce costly over-specification of components
- Contribute to design reviews.
- Coordinate with Regulatory group to ensure regulatory compliance and auditing support - RoHS, REACH
- Provide data to Mechanical and Thermal Engineers to optimize packaging, manufacturability, and reliability.
- Participate occasionally with the development team to build and test prototypes.
- Provide support to complete the documentation and production release of the product, including development of a Technical Transfer (Theory of Operation) to Manufacturing and Quality personnel.
- Altium schematic and PWB design tool librarian - process requests for new parts to be entered into the Altium shared Global Library.
- Work independently with departments such as Engineering, Project Management, Purchasing, Manufacturing and Quality to ensure consistently producible quality camera systems
- Originate and update Engineering Specification sheets.
- Provide analytical support and simulations of electronic component performance to the product development teams
- Provide training and occasional seminar/tutorials on component characteristics and selection to Engineers.
- Will spend part of his/her time as a member of continuous improvement teams undertaking projects and seeking ways to improve the quality of KSI's products and services .
- Research and recommend new design techniques for KSI, including new electronic components, analytical models, and techniques.
- Analysis and Modeling
- Develop analytical and test methods to objectively quantify component characteristics.
- Determine, where appropriate, empirical methods to validate analytical models. If necessary, update the model assumptions and/or empirical methods to correlate the results.
- Document results in technical reports and design review presentations.
- Regular attendance is an essential job function.
ADDITIONAL RESPONSIBILITES: List other important functions that are secondary duties but may be time consuming.
- 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.
- Durability - all activities associated with this position must address the long-term durability of the design.
- Efficacy - all activities associated with this position must consider the device's final application.
- Performs other related duties as assigned by supervisor.
KNOWLEDGE, SKILLS, ABILITIES: What does a person in this position need to be able to do?
- Knowledge of the U.S. FDA Quality System Regulation, 21 CFR Part 820 (QSR), and knowledge of international quality system standards, ISO 13485, ISO 9001.
- Evaluate electronic component data sheets and characteristics and their applicability to specific circuit applications.
- Improve and create department processes related to component selection and qualification.
- Must be detail-oriented with high accuracy.
- Must be able to understand/operate advanced test equipment.
- Must have excellent oral and written communication skills.
EDUCATION AND EXPERIENCE: What is the usual educational background and work experience of an individual qualified to perform this job?
- Bachelor of Science degree, or Masters of Science degree, with at least 8 years of experience in electronics design and analysis of analog and digital circuits. And minimum 10 years' experience with component engineering
- Design familiarity with image sensors, FPGAs, microprocessors, and memory, preferred
- Experience with and knowledge of video systems and CCD and CMOS imager technology, preferred
- Familiarity with Endoscopy in a Medical Device company a plus
PHYSICAL & MENTAL REQUIREMENTS: What are the specific physical and mental demands of this position?
- Visual acuity sufficient for testing.
- Ability to sit for extended periods (during meetings and computer work).
- Ability to lift video and test equipment (approx. 15 lbs).
- Ability to connect electrical devices.
TRAINING REQUIREMENTS: Safety, regulatory compliance, legal & job specific.
- Injury and Illness Prevention Program; annually - OSHA requirement
- Job Specific - In house requirement
* We are unable to sponsor or take over sponsorship of an employment at this time
#LI - LS1
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Vaccine requirements at KARL STORZ due to COVID-19
KARL STORZ is committed to maintaining a safe work environment for our employees and therefore we require the COVID-19 vaccine for all of our employees unless otherwise due to an underlying medical condition or sincerely held religious beliefs. During the interview process, we encourage you to ask how COVID-19 may impact the role you are seeking and if you require a reasonable accommodation regarding the vaccine requirement see below on the process for requesting accommodation. Please click here to learn more about our overall response to COVID-19.
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, 10 holidays plus paid sick time*
- 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
- Tuition reimbursement of up to $5,250 per year
- Fitness reimbursement up to $200 annually
- Employee referral program of up to $2,000 per hire
*Field sales, internships and part-time employees are not eligible except for where required by state law.
Non-employees, including temporary workers and consultants, are not eligible to participate in KARL STORZ benefits program.
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. Employee 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 TaleoAdministrator@karlstorz.com.
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 KARL STORZ Human Resources department will be ineligible for referral fees.
Goleta, CA
Global company stability. Small company feel.
At KARL STORZ, you’ll have the opportunity to develop a more rewarding career filled with opportunities that you never thought possible.
Where technology meets humanity
KARL STORZ has been a leading provider of advanced endoscopy systems and related medical technology for more than 75 years.
We’re all about long-term, sustainable development—and that goes for both our products and our people. Our family-oriented culture gives you the tools you need to thrive at work and the time you need to recharge at home.
You’ll get to bring your authentic self to work every day and advance your career with a company that shares your goals—another reason why so many people on our team have stayed with us for so long.
Join KARL STORZ and experience a more enriching career, one where the work you do supports our goal to put best-in-class medical technology into the hands of skilled surgeons to save patient lives every day.