This job is closed
We regret to inform you that the job you were interested in has been closed. Although this specific position is no longer available, we encourage you to continue exploring other opportunities on our job board.
Component Compliance Engineer III
Karl Storz - Goleta, CA
posted 2 months ago
About the position
The Component Compliance Engineer III at KARL STORZ plays a crucial role in enhancing global health through innovative medical technology. This position focuses on the selection, qualification, and management of components for medical devices, ensuring compliance with quality standards and collaborating with cross-functional teams to resolve component-related issues. The engineer will leverage their extensive experience to drive innovation and optimize system performance in the development of life-changing medical devices.
Responsibilities
- Lead component selection, qualification, and management for medical devices.
- Develop and maintain global guidelines for component selection and usage.
- Collaborate with cross-functional teams to resolve component-related issues.
- Analyze electronic component data sheets and characteristics for specific circuit applications.
- Improve department processes related to component selection and qualification.
- Provide technical support for design, manufacturing, and quality teams.
- Create and maintain Engineering Specification sheets.
- Support Electronics Engineers on component analysis, specifications, target costs, and cost reductions.
- Originate and update component definitions and entries into the parts library for schematic and PWB design tools.
- Participate in design reviews and contribute to design optimization.
- Develop analytical and test methods to quantify component characteristics.
Requirements
- Bachelor's or Master's degree in Electrical Engineering, Component Engineering, or related field.
- 8+ years of experience in electronics design and analysis, with 10+ years in component engineering.
- Knowledge of FDA Quality System Regulation (21 CFR Part 820) and international quality standards (ISO 13485, ISO 9001).
- Excellent communication, problem-solving, and analytical skills.
Nice-to-haves
- Experience with image sensors, FPGAs, microprocessors, and memory.
- Familiarity with video systems, CCD and CMOS imager technology, and Endoscopy in Medical Devices.
- Altium schematic and PWB design tool experience.
Benefits
- Medical / Dental / Vision including a state-of-the-art wellness program and pet insurance.
- 3 weeks vacation, 11 holidays plus paid sick time.
- Up to 8 weeks of 100% paid company parental leave; includes maternal/ paternal leave, adoption, and fostering of a child.
- 401(k) retirement savings plan providing a match of 60% of the employee's first 6% contribution (up to IRS limits).
- Section 125 Flexible Spending Accounts.
- Life, STD, LTD & LTC Insurance.
- Tuition pre-reimbursement up to $5,250 per year.
- Fitness reimbursement of up to $200 annually.
