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Validation Engineer Medical Devices Jobs in Rochester, NY

... and Validation) for Medical Devices. Experience or knowledge of evaluation and statistical analysis using methods such as the CLSI documents. Experience in identifying and resolving problems for ...

Adapts instruction using case studies of medical devices, MATLAB simulation exercises, and design project guidance to support undergraduate biomedical engineering students bridging life sciences and ...

Responsibilities will include, programing, reading, generating reports, as well as conducting ... Our Total Rewards include: * 100% employer-paid medical premiums (a $2,000-$6,000+ annual value ...

... and Validation) for Medical Devices. Experience or knowledge of evaluation and statistical analysis using methods such as the CLSI documents. Experience in identifying and resolving problems for ...

The role is primarily responsible for analytical testing of medical devices, components, raw materials, stability samples, validation samples, and extractables and leachables samples using ...

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Validation Engineer Medical Devices information

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$22

$51

$77

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

As of Aug 8, 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.

Packaging Engineer

Rochester Precision Optics LLC

West Henrietta, NY • On-site

$95K - $105K/yr

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Re-posted 20 days ago


Job description

Title

Packaging Engineer

Department

Manufacturing Engineering

Reports to

Director of Production Engineering


SEE YOUR CAREER THROUGH A NEW LENS WITH RPO!

RPO is a global leader in precision optics, optical components, and optical assemblies. We specialize in a full spectrum of products & services including – Design and Engineering, Systems Integration, Lens Assembly, Visible and Infrared Components, Glass and Plastic Molded Aspheres, and Thin Film Coating. As one of the fastest growing companies in Rochester, RPO offers exciting career paths and work on market-leading programs. See below one of many career opportunities to join the RPO team!


Position Overview:

The Packaging Engineer is responsible for the design, development, validation, and continuous improvement of packaging solutions used to protect precision optical components and assemblies throughout manufacturing, storage, and customer delivery. This role supports both internal product movement and external shipment, ensuring components remain protected from damage, contamination, and handling risks while meeting customer, quality, and regulatory requirements. Working closely with Operations, Quality, Engineering, and Supply Chain teams, the Packaging Engineer will develop practical packaging systems that improve product protection, support manufacturing flow, reduce handling risk, and enhance operational efficiency. The ideal candidate combines strong engineering fundamentals with hands-on problem-solving skills and experience supporting high-value, fragile, or precision-manufactured products.


Key Responsibilities:

  • Design, develop, and implement packaging solutions for precision optical components, assemblies, and finished products.
  • Engineer reusable trays, totes, fixtures, and handling systems used throughout the manufacturing process.
  • Develop customer-facing packaging solutions that meet product protection, cleanliness, transportation, and regulatory requirements.
  • Evaluate packaging performance through drop, vibration, compression, environmental, and distribution testing.
  • Select, qualify, and validate packaging materials suitable for precision optics and environmentally controlled manufacturing environments.
  • Create and maintain packaging drawings, specifications, work instructions, bills of material, and engineering change documentation.
  • Collaborate with Operations, Quality, Supply Chain, and Engineering teams to ensure packaging supports efficient product flow and product protection.
  • Investigate packaging-related quality issues, shipping damage, and handling concerns and implement corrective actions.
  • Standardize packaging solutions across product families where appropriate to improve consistency and reduce costs.
  • Support new product introduction activities by developing packaging requirements and validation plans.
  • Analyze packaging costs, material utilization, and operational efficiency to identify improvement opportunities.
  • Lead continuous improvement initiatives focused on damage reduction, handling efficiency, storage optimization, and packaging performance.
  • Support customer packaging requirements, audits, and packaging-related technical inquiries as required.


Required Qualifications:

  • Bachelor's degree in Packaging Science, Packaging Engineering, Mechanical Engineering, Industrial Engineering, or a related technical discipline.
  • Minimum of 5 years of experience in packaging engineering supporting manufacturing environments.
  • Experience developing packaging solutions for precision components, medical devices, electronics, aerospace products, optics, semiconductor products, or other fragile/high-value products.
  • Proficiency with CAD software, preferably SolidWorks, for the design of packaging components, trays, fixtures, and handling systems.
  • Experience performing packaging validation testing and familiarity with ISTA, ASTM, and other industry-standard test methods.
  • Demonstrated ability to design custom packaging, trays, dunnage, and protective handling solutions.
  • Experience selecting and qualifying packaging materials including foams, plastics, engineered corrugates, protective films, and specialty materials.
  • Familiarity with product handling, contamination control, ESD protection, or cleanroom-compatible packaging practices is strongly preferred.
  • Experience creating engineering drawings, specifications, bills of material, and engineering change documentation.
  • Strong analytical, troubleshooting, and root-cause problem-solving skills.
  • Effective communication skills and ability to work cross-functionally with engineering, manufacturing, quality, and supply chain teams.
  • Experience supporting new product introduction (NPI), manufacturing transfer, or product launch activities is preferred.

Core Competencies:

  • Results-Oriented: Motivated, hard-working and ready to level up.
  • Curious: You never stop learning and have an insatiable desire to gain new skills and knowledge.
  • Process Oriented: Well organized, demonstrating attention to detail.
  • Analytical: Possess a “If there’s a problem, I’ll find a solution” attitude.
  • Accountable: Demanding the highest quality from yourself and team members.
  • Detail-Oriented: Have excellent time management and organizational skills.
  • A Team Player: Reliable, collaborative, flexible with a positive ‘get things done’ attitude.

Additional Requirements:

Pursuant to ITAR, EAR, and other export compliance laws and regulations, applicants for this position must be U.S. Persons as defined by U.S. law, i.e., U.S. citizens, lawful permanent residents ("Green Card" holders), persons granted refugee status or asylum status in the United States, or temporary residents granted amnesty.

Compensation & Benefits:

  • Competitive compensation package linked to your experience and performance.
  • 401(k) with company match and Tuition Reimbursement opportunities.
  • Health, dental, vision, HSA, & life insurance.
  • Paid time off including vacation, sick time, and 11 paid company holidays

Work Environment & Physical Demands:

  • Works in a precision manufacturing environment supporting production operations, with regular time spent on the manufacturing floor and in engineering or office settings.
  • Frequent interaction with production personnel, manufacturing equipment, tooling, and assembly processes in support of troubleshooting, process development, and continuous improvement activities.
  • Requires prolonged periods of standing, walking, and moving throughout production areas, with occasional sitting for engineering, documentation, and project-related work.
  • Regular use of hands for computer work, documentation, handling components, tooling, fixtures, and measurement equipment.
  • Requires visual acuity for reviewing technical documentation, inspecting components and assemblies, and supporting process verification activities.
  • Exposure to typical manufacturing conditions, including moving mechanical equipment, moderate noise levels, airborne particles, cleaning agents, adhesives, oils, and solvents.
  • Required use of personal protective equipment (PPE), including safety glasses and cleanroom or controlled-environment garments, as required by specific production areas.
  • Occasional lifting or movement of materials, tooling, fixtures, or equipment, typically up to 50 pounds.
  • May require schedule flexibility or extended hours to support production priorities, troubleshooting activities, or project implementation deadlines.



Disclaimer:

This job description reflects management’s assignment of essential functions; it does not prescribe or restrict the tasks that may be assigned. The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.

Rochester Precision Optics is committed to leveraging the talent of a diverse workforce to create great opportunities for our business and our people.

EOE/AA/Race/Gender/Disability/Veteran

In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States, and to complete the required employment eligibility verification form upon hire.




This position is scheduled for Monday through Friday, 7:00 AM – 3:30 PM. As an engineer supporting multiple production operations, occasional flexibility outside normal business hours may be required to support manufacturing priorities, project implementation, troubleshooting activities, or critical production needs.