Description Summary of Position This position is responsible for the design, development, verification, and documentation of Class II medical device hardware and software systems. The role requires hands-on experience wi…
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Full-time
bachelor degree
Posted 17d ago
~40 hrs/week
Responsibilities
Responsible for the design, development, and verification of Class II medical device hardware and software systems. This includes creating regulator-ready technical documentation and serving as a technical lead during FDA and EU MDR audits.
Requirements
Requires a Bachelor's degree in Electrical or Biomedical Engineering with over 10 years of experience in medical device product development. Must have hands-on expertise in PCB design, embedded software, and international regulatory standards.
Full job description
Description
Summary of Position
This position is responsible for the design, development, verification, and documentation of Class II medical device
hardware and software systems. The role requires hands-on experience with PCB development, embedded
software coding and assembly, and the creation of regulator-ready technical documentation. The position will
execute verification protocols and reports, interpret and apply standards such as IEC 60601-1, IEC 62304, and IEC
62366, and contribute to design control activities throughout the product lifecycle. The position also participates as
a technical lead during internal and external inspections/audits (i.e. FDA, EU MDR, UK MDR).
Primary Job Responsibilities
Primary job responsibilities include, but are not limited to:
Participate in the development of new products and revisions to existing products in accordance with
company design control procedures.
Support electrical and software development activities, including PCB design reviews, prototype builds,
debugging, and firmware implementation.
Develop, execute, and document verification protocols, test methods, and reports with full traceability to
requirements.
Create and maintain Design Control documents including design plans, specifications, risk analyses,
verification protocols, and reports.
Interpret and apply requirements from IEC 60601-1 (electrical safety), IEC 62304 (software lifecycle), and
IEC 62366 (usability engineering).
Coordinate with internal and external resources, including third-party contractors, to support development
activities.
Participate in design reviews, risk reviews, and cross-functional technical discussions.
Support manufacturing engineering during transfer-to-production, troubleshooting, and fixture
development.
Perform PCB-level troubleshooting using oscilloscopes, logic analyzers, and other diagnostic tools.
Contribute to the Design History File (DHF), Device Master Record (DMR), and Risk Management File
(RMF).
Accountability (size of responsibility)
Ensuring compliance with Quality Management System requirements for Design Control and Risk
Management.
Coordination with Manufacturing, Quality Assurance, Regulatory Affairs, and other departments to
support product development.
Budget responsibility determined in concert with Sr Director and reported accordingly.
Requirements
Qualifications
Bachelor’s degree in Electrical Engineering, Biomedical Engineering, or related technical field with +10
years of experience in Class II medical device product development or related engineering role.
Hands-on experience with PCB design, assembly, debugging, and embedded software development.
Demonstrated ability to create technical documents, verification protocols, and engineering reports.
Experience with domestic and international medical device regulatory requirements; IEC 60601-1, IEC
62304, IEC 62366, and ISO 14971.
Strong attention to detail with excellent written and verbal communication skills.
Ability to interpret complex standards and translate them into engineering and product requirements.
Related keywords
Class II Medical DevicesPCB DevelopmentEmbedded SoftwareIEC 60601-1IEC 62304IEC 62366ISO 14971Design ControlDesign History FileDevice Master RecordRisk Management FileFDAEU MDRUK MDRVerification ProtocolsFirmware
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Offices: 200 Forge Way Suite, Suite 205, Rockaway, NJ 07866, US
Based on 3806 listings with disclosed salaries, most healthcare jobs in New Jersey pay between $71k–$210k per year. Individual offers vary with seniority, company size, and specialization.
How many Healthcare jobs are open in New Jersey right now?
There are currently 16,188 open healthcare positions in New Jersey listed on Clera. New openings are added daily as companies post roles.
Which companies are hiring for Healthcare roles in New Jersey?
Companies currently hiring include Hackensack Meridian Health, CVS Health, Atlantic Health, Cooper University Health Care, BAYADA Home Health Care, among others. Browse the listings above to see every active employer.
Are there remote or hybrid Healthcare jobs in New Jersey?
Yes — 2085 of the 16188 open healthcare positions offer remote or hybrid work (561 remote, 1524 hybrid).
How do I apply for Healthcare jobs in New Jersey?
Each listing links directly to the employer's application page. Apply early — fresh listings get the most recruiter attention in the first two weeks.