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.).

DEXIS is looking for individuals who work their best, help others, and commit to helping us improve our customer lives and celebrate the difference in others.

Who is DEXIS and why should you join the team?

We are the leading manufacturer and distributor of innovative dental imaging equipment, software, and solutions. We offer meaningful work through innovation, diverse opportunities, and career progression.

We also offer

- Competitive Pay and Bonuses.
- PTO, Sick Time and Paid Holidays.
- Competitive leave policies including but not limited to Sick, Jury Duty, Bereavement, Personal, and Parental Leave Medical, Dental, and Vision Insurance Benefits effective DAY ONE!!!!
- 401K – with exceptional company match starting DAY ONE!!!!
- Community involvement opportunities & employee appreciation events.
- Newly renovated, state of the art, climate-controlled facility.
- Newly built 1200 sq fitness room.
- Gourmet coffee, beverages, snacks, and lunches are available in our café.
- Employee Lounge with pool table, shuffleboard and skeet ball for downtime and employee fun!

Where are we?

Situated on the southern edge of the Lehigh Valley and easily accessible from northern Philadelphia suburbs and the surrounding areas, the Quakertown facility is our North American hub for the design and manufacturing of leading dental imaging devices and software.  The facility has a growing, energetic, and diverse mix of professionals spanning engineering, operations, regulatory and quality backgrounds that work collaboratively in the fast-paced medical device field.  A friendly and open atmosphere helps to foster strong personal and professional relationships across the organization.

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

Dental Imaging Technologies Corporation is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, national origin, religion, gender, age, marital status, disability, veteran status, sexual orientation, gender identity, or any other characteristic protected by law.

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Operating Company:

DEXIS

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