Job Description:JOB SUMMARY:
The Electrical Engineer - Compliance is responsible for ensuring that products are designed, developed, tested, and sustained in compliance with all applicable agency and market requirements.
The ideal candidate must reside within a commutable distance to Quakertown, PA, as the position requires onsite presence 4 days per week.
PRIMARY DUTIES & RESPONSIBILITIES:- Ensures timely completion of electrical engineering deliverables, such component selection, schematic capture, PCB layout, testing, etc.
- Ensures all devices (new product and existing product changes) meet compliance, performance, and cost specifications.
- Generates applicable QMS (quality management system) documentation such as theory of operation, formal design reviews, formal test reports as well as contributing content to user manuals.
- Provides input to project scheduling and management.
- Participates in and provides guidance for design reviews, FMEA, Risk Analysis and Usability Engineering activities.
- Contributes to QMS procedure maintenance as applicable.
- Obtains product certification/recognition to applicable EN, ISO & IEC 60601-1 general, collateral, and standards through 3rd party compliance laboratories (UL, ETL, TUV, BSI, etc.).
Job Requirements:- B.S. degree in Electrical/Electronic Engineering Technology, Computer Engineering Technology, or Biomedical
- Engineering. 6 years' experience in the design / testing and analysis in electronic circuits
- Basic understanding of device safety standard, IEC 60601-1, including the ability to identify applicable collateral and particular standards via review of each medical device design.
- Working knowledge of analog / digital circuits.
- Experience with developing design documentation including formal test reports; participated in FMEA and design reviews.
- Excellent communication skills (written and verbal)
- Ability to work independently and with a cross functional team.
PREFERRED QUALIFICATIONS:- Medical device design and compliance experience.
- M.S. degree preferred.
- Compliance Engineering:
- Performed GAP assessment, i.e. analyze product design and documentation vs. applicable standards and/or updates to standards.
- Lead projects with 3rd party compliance laboratories (UL, ETL, TUV, BSI, etc.).
- Has developed EMC test plans
- Analog/Digital/Power Conversion circuit design.
- Schematic Capture and the design of PCBs using CAD software (experience with Altium highly desirable).
- Has analyzed schematics; test & trouble shoot PCB to component level; works with oscilloscopes, logic analyzers, spectrum analyzers, DMMs.
- Has simulation tool experience.
- Has firmware and software design experience with the ability to program in C and Python
- Has developed EMC Test Plans, conducted EMC evaluations, and EMC noncompliance mitigations.
- Has developed system interconnect solutions i.e., cabling/wiring.
- Contributed to cross-functional problem solving.
- Collaboration with cross functional teams: mechanical engineering, software engineering, quality engineering, regulatory affairs.
- Has developed FMEA, Risk Analysis and Usability Engineering documentation (ISO 14971 highly desirable).
- Experience with FDA 510K cleared medical devices and has contributed to 510K submissions.
- Experience with ISO quality management systems and processes (ISO 13485 highly desirable).
- Designed and lead construction of test fixtures.
- Fundamental understanding of:
- Design for Manufacturing, Sourcing, Assembly, Reliability Principles
- Human Factors and Usability Engineering Considerations
- Risk Analysis and Mitigation
- Component selection
- Value engineering principles
Target Market Salary Range:Actual compensation packages take into account a wide range of factors that are unique to each candidate, including but not limited to geographic location; skill sets; relevant education and certifications; depth of experience; performance; and other business and organizational needs. The disclosed reasonable estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. At Envista, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. The total compensation package for this position may also include an annual performance bonus, medical/dental/vision benefits, 401K match, and/or other applicable compensation plans.
For Field Sales roles, the salary range listed reflects base pay only and does not include incentive pay opportunities under the applicable sales compensation plan
$121,000 - $143,400
Operating Company:DEXIS
