DEXIS Electrical Engineer (Quakertown, PA)

Envista Holdings Corporation•Quakertown, PA

2d•$121,000 - $143,400•Hybrid

About The Position

The Electrical Engineer - Compliance ensures products are designed, developed, tested, and sustained in compliance with applicable agency and market requirements. The role requires onsite presence four days per week at the Quakertown, Pennsylvania facility, and candidates must live within a commutable distance. The engineer completes electrical engineering deliverables, including component selection, schematic capture, PCB layout, and testing, and ensures new products and changes to existing products meet compliance, performance, and cost specifications. The position also produces quality management system (QMS) documentation, contributes to project scheduling and management, participates in design and risk-related activities, and supports maintenance of QMS procedures. The engineer obtains product certifications or recognitions to applicable EN, ISO, and IEC 60601-1 standards through third-party compliance laboratories. DEXIS manufactures and distributes dental imaging equipment, software, and solutions. Its Quakertown facility is a North American hub for design and manufacturing, with cross-functional teams in engineering, operations, regulatory, and quality.

Requirements

Bachelor of Science degree in Electrical/Electronic Engineering Technology, Computer Engineering Technology, or Biomedical Engineering.
Six years of experience in the design, testing, and analysis of electronic circuits.
Basic understanding of device safety standard IEC 60601-1, including identifying applicable collateral and particular standards by reviewing medical device designs.
Working knowledge of analog and digital circuits.
Experience developing design documentation, including formal test reports, and participating in FMEA and design reviews.
Excellent written and verbal communication skills.
Ability to work independently and with a cross-functional team.

Nice To Haves

Medical device design and compliance experience.
Master of Science degree.
Experience performing gap assessments of product designs and documentation against applicable standards or updates to standards.
Experience leading projects with third-party compliance laboratories such as UL, ETL, TUV, or BSI.
Experience developing EMC test plans.
Analog, digital, and power conversion circuit design experience.
Schematic capture and PCB design using CAD software; Altium experience is highly desirable.
Experience analyzing schematics and testing and troubleshooting PCBs to component level using oscilloscopes, logic analyzers, spectrum analyzers, and DMMs.
Experience with simulation tools.
Firmware and software design experience, including ability to program in C and Python.
Experience developing EMC test plans, conducting EMC evaluations, and mitigating EMC noncompliance.
Experience developing system interconnect solutions such as cabling and wiring.
Experience contributing to cross-functional problem solving and collaborating with mechanical engineering, software engineering, quality engineering, and regulatory affairs.
Experience developing FMEA, Risk Analysis, and Usability Engineering documentation; ISO 14971 experience is highly desirable.
Experience with FDA 510K-cleared medical devices and contributing to 510K submissions.
Experience with ISO quality management systems and processes; ISO 13485 experience is highly desirable.
Experience designing and leading construction of test fixtures.
Fundamental understanding of design for manufacturing, sourcing, assembly, and reliability principles; human factors and usability engineering considerations; risk analysis and mitigation; component selection; and value engineering principles.

Responsibilities

Complete electrical engineering deliverables in a timely manner, including component selection, schematic capture, PCB layout, and testing.
Ensure new products and changes to existing products meet compliance, performance, and cost specifications.
Generate QMS documentation, including theory of operation, formal design reviews, and formal test reports, and contribute content to user manuals.
Provide input to project scheduling and management.
Participate in and provide guidance for design reviews, FMEA, Risk Analysis, and Usability Engineering activities.
Contribute to maintenance of QMS procedures as applicable.
Obtain product certification or recognition to applicable EN, ISO, and IEC 60601-1 standards through third-party compliance laboratories.

Benefits

Competitive pay and bonuses.
PTO, sick time, and paid holidays.
Leave policies including sick, jury duty, bereavement, personal, and parental leave.
Medical, dental, and vision insurance effective on the first day.
401(k) with company match starting on the first day.
Community involvement opportunities and employee appreciation events.
Newly renovated, climate-controlled facility.
On-site fitness room.
Café with coffee, beverages, snacks, and lunches.
Employee lounge with recreational games.