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Validation Engineer Medical Devices Jobs in Rochester, NY

Engineering Program Manager

Rochester, NY · On-site

$101.10 - $146.70/hr

... Chief Engineer where they will lead a team of Engineers to design and develop a cutting-edge ... Medical and dental coverage * Employer paid basic life, short-term disability, and identity theft ...

New

Senior Controls/Systems Engineer

Fairport, NY · On-site

$92K - $121K/yr

Configure PLCs, HMIs, SCADA systems, sensors, and industrial devices to provide reliable ... Lead CAPEX projects including vendor management, FAT/SAT, startup, and validation. * Mentor junior ...

Configure PLCs, HMIs, SCADA systems, sensors, and industrial devices to provide reliable ... validating manufacturing data quality, equipment signals, and production event data used for ...

Sr. Controls Project Engineer

Webster, NY · On-site

$130K - $150K/yr

... electrical devices. * Ensure the electrical design is functional, robust, and cost effective ... Support software validation requirements. * Work with suppliers to find/develop the most functional ...

Sr. Controls Project Engineer

Webster, NY · On-site

$130K - $150K/yr

... electrical devices. * Ensure the electrical design is functional, robust, and cost effective ... Support software validation requirements. * Work with suppliers to find/develop the most functional ...

Software Quality Engineer

Rochester, NY · On-site +1

$61K - $97K/yr

Ensure applications work across different devices, browsers including Edge, Chrome, Firefox and ... Validate end-to-end customer workflows, data integrity, integrations, business rules, and data ...

New

Design, develop, validate, and maintain manufacturing test processes, fixtures, and automated test ... About Qualitrol QUALITROL manufactures monitoring and protection devices for high value electrical ...

Design, develop, validate, and maintain manufacturing test processes, fixtures, and automated test ... About Qualitrol QUALITROL manufactures monitoring and protection devices for high value electrical ...

Regulatory Affairs Lead

Rochester, NY · On-site

$125K - $130K/yr

S. regulatory strategies for medical devices with alignment to future pharmaceutical and ... Cross-Functional Leadership Collaborate with Engineering, R&D, Manufacturing, Quality, Clinical ...

Regulatory Affairs Lead

Rochester, NY · On-site

$125K - $130K/yr

S. regulatory strategies for medical devices with alignment to future pharmaceutical and ... Cross-Functional Leadership • Collaborate with Engineering, R&D, Manufacturing, Quality, Clinical ...

Showing results 41-60

Validation Engineer Medical Devices information

See Rochester, NY salary details

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$51

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How much do validation engineer medical devices jobs pay per hour?

As of Aug 7, 2026, the average hourly pay for validation engineer medical devices in Rochester, NY is $51.30, according to ZipRecruiter salary data. Most workers in this role earn between $38.89 and $62.36 per hour, depending on experience, location, and employer.

What is a validation engineer medical devices?

A Validation Engineer in medical devices ensures that products, processes, and equipment meet regulatory and quality standards. They develop and execute validation protocols, conduct tests, analyze data, and document results to ensure compliance with FDA, ISO 13485, and other regulations. Their role is crucial in verifying that medical devices are safe, effective, and consistent in performance before they reach the market.

What are some typical challenges faced by validation engineers in the medical device industry?

Validation Engineers in the medical device industry often encounter challenges such as navigating ever-evolving regulatory standards, managing tight project timelines, and ensuring thorough documentation for audits. They are frequently tasked with balancing the need for comprehensive testing and validation with efficiency to support product development cycles. Working closely with cross-functional teams—including design, quality assurance, and manufacturing—requires strong collaboration and adaptability. Overcoming these challenges helps ensure that medical devices are safe, effective, and compliant with industry regulations, making the role both demanding and highly impactful.

What are the key skills and qualifications needed to thrive as a validation engineer medical devices?

A Validation Engineer in Medical Devices needs a strong background in biomedical engineering or a related field, knowledge of regulatory requirements (such as FDA or ISO 13485), and expertise in validation methodologies. Familiarity with tools like statistical analysis software, quality management systems (QMS), and documentation platforms is often required, as well as certifications such as CQE (Certified Quality Engineer). Strong attention to detail, problem-solving abilities, and effective communication skills are essential to excel in this role. These competencies are critical to ensure medical devices meet rigorous safety and compliance standards, protecting patient health and supporting successful product launches.

What are popular job titles related to Validation Engineer Medical Devices jobs in Rochester, NY? For Validation Engineer Medical Devices jobs in Rochester, NY, the most frequently searched job titles are:
What job categories do people searching Validation Engineer Medical Devices jobs in Rochester, NY look for? The top searched job categories for Validation Engineer Medical Devices jobs in Rochester, NY are:
Infographic showing various Validation Engineer Medical Devices job openings in Rochester, NY as of July 2026, with employment types broken down into 1% As Needed, 79% Full Time, 15% Part Time, 1% Temporary, 3% Contract, and 1% Nights. Highlights an 96% Physical, 1% Hybrid, and 3% Remote job distribution, with an average salary of $106,711 per year, or $51.3 per hour.

Engineering Program Manager

D3 Engineering

Rochester, NY • On-site

$101.10 - $146.70/hr

Other

Medical, Dental, Vision, Life, Retirement

Posted 2 days ago

New


Job description

Engineering Program Manager

Department: Product Design Services
FLSA Status: Exempt
Reports to: Operations Manager, Product Design Services
Pay Range: $101,100 - $146,700 annually
Location: Rochester, NY (On-site/Hybrid)

The Role

D3 Embedded is seeking a skilled and experienced Engineering Program Manager to act in the role of Chief Engineer where they will lead a team of Engineers to design and develop a cutting-edge embedded system. The systems are end-to-end solutions containing sensors, cameras, mmWave Radar, connectivity, embedded processing and Artificial Intelligence (AI) for performance critical applications. The ideal candidate has experience with Embedded Realtime Operating Systems (RTOS) like Embedded Linux, digital imaging, electronics design, software architecture and development, computer vision and machine learning. This position requires strong problem-solving skills, the ability to mentor and guide engineering teams.

The Responsibilities
  • Lead a project team to develop an embedded system and realize the solution using company core process
  • Collaborate with key stakeholders to define program scope, timing, and deliverables and use them to execute the program and track progress
  • Coordinate multi-disciplinary project team leads
  • Manage project to milestones (Schedule and Outcomes)
  • Manage resources including teams, budgets, and schedules, to maximize customer satisfaction and project profitability
  • Identify, assess, and mitigate risks that may affect program delivery
  • Act as the technical decision maker driving complex technical decisions across multiple teams (Facilitates the discussion to define “done”)
  • Provide primary technical communication with project team and project stakeholders
  • Maintain effective communication channels to keep stakeholders updated on project progress and changes
  • Facilitate technical and stakeholder meetings
  • Responsible for making sure the right people are on each task and the tasks are understood by the team
  • Collaborate with management and technical teams on product strategies
  • Prep and lead gate/design reviews and provide technical oversight
  • Develop and finalize requirements
  • Develop electrical and mechanical block diagrams, and high-level software architectures to meet requirements and guide design trade-off decisions
  • Provide estimations for next phases of a current project using change requests
  • Maintain project documentation, including plans, schedules, budgets, and status reports.
  • Requestor for Materials purchases and shipments for projects
  • Approver for Design Releases (Arena ECOs)
  • Own the full life cycle of new products/solutions from proof of concept to integration with other components and teams
  • Lead and/or participate in all phases of the product development cycle including:
    • requirements definition and architecture
    • software design and development
    • implementing software
    • software/hardware integration
    • verification and validation, and customer support
  • Develop & identify tools / methods for better design reuse & process improvement
  • Mentor junior engineers
Additional Responsibilities
  • Other duties as assigned
The Right Person Will Have (Required)
  • 3+ years of experience working as a Technical Lead, Technical Project Manager, or Program Manager for both hardware/software projects.
  • Bachelor of Science Degree in Software Engineering, Electrical Engineering, Computer Science, Computer Engineering or a related field.
  • 5+ years of industry experience
  • Experience with System Requirements Documentation, Requirements Allocation, Requirements Traceability, and Test Case development and execution. Experience with product and component-level FMEAs.
  • Self-driven personality
  • Capable of a big picture, system-oriented approach
  • Solid technical leadership skills
  • Strong communication and interpersonal skills
The Right Person Will Have (Preferred)
  • Master of Science or PhD in Computer Vision, Machine/Deep Learning, Computer Science, Computer/Electrical/Software Engineering, or a related field.
  • Experience with autonomous/industrial robotic platforms and applications
  • Experience with embedded and edge processing platforms (Nvidia Jetson devices, Qualcomm Snapdragon devices, and Texas Instrument Jacinto devices in particular)
  • Experience with edge AI (accelerators, integration, model conversions, deployment, profiling, etc.)
  • Knowledge of intrinsic and extrinsic calibration procedures for multi-modal sensor systems
  • Experience with sensor fusion techniques (calibration, early, mid, late fusion, etc.)
  • Knowledge of camera optics and computational geometry
  • Gstreamer experience
  • Robot Operating System (ROS) experience
  • Experience with version control systems such as GIT and DVC
  • Experience with GPU programming frameworks such as OpenCL and CUDA
  • Experience with Embedded Real-Time Operating Systems (RTOS) and Embedded Linux
The Benefits
  • Competitive total compensation
  • Medical and dental coverage
  • Employer paid basic life, short-term disability, and identity theft coverage
  • Voluntary vision, life, long-term disability, accident, critical illness coverage
  • 401k retirement contribution
  • Paid holidays, time-off, and sick time
  • Tuition assistance and employer paid professional development
  • Flexible work schedules
  • Remote opportunities available
  • Complimentary snacks and beverages
  • Employer sponsored social events
The Company

Since our founding in 1999, D3 Embedded has driven innovation in high-performance embedded systems development. We leverage our expertise in autonomous machines, sensors, imaging, optics, edge computing, algorithms, robotics, and electrification to provide cutting-edge engineering design and low-volume manufacturing services. Headquartered in Rochester NY, we serve a global network of customers and are proudly connected with many technology leaders and Fortune 500 companies. We are interested in bright, creative, and team-oriented individuals exhilarated by the opportunity to transform the world through frontier technologies.

Candidates must be eligible to work in the United States. D3 Embedded does not sponsor visas. For more information about D3 Embedded, please visit www.d3embedded.com.

D3 Embedded is committed to fostering a diverse work environment and proud to be an Equal Opportunity Employer. We consider and hire applicants without regard to race, color, religion, age, national origin, ancestry, ethnicity, gender, gender identity, gender expression, sexual orientation, marital status, veteran status, disability, genetic information, citizenship status, or membership in any other group protected by federal, state or local law.

D3 Embedded participates in E-Verify, a federal program that confirms employment eligibility upon hire.

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