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Validation Engineer Medical Devices Jobs in Rochester, NY

Bausch + Lomb

Compliance Engineer II

Rochester, NY · On-site

$65K - $100K/yr

Manage and maintain the Master Validation plan for the qualification and requalification of ... medical devices and/or clean room environment compliance regulations with Quality Engineering ...

Integrated Resources INC

Scientist I

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 ...

Unifin SAS

Validation Technician

Rochester, NY · On-site

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 ...

TRIMEDX Holdings

Biomedical Technician I

Rochester, NY

$25 - $33/hr

Performs Incoming Inspections (II) to maintain a complete and accurate inventory of medical devices ... Valid driver's license required; variable travel requirements depending on primary site that may ...

Trimedx

Biomedical Technician I

Rochester, NY · On-site

$25 - $33/hr

Performs Incoming Inspections (II) to maintain a complete and accurate inventory of medical devices ... Valid driver's license required; variable travel requirements depending on primary site that may ...

onsemi

Application Engineer for SiC JFET

Livonia, NY · On-site

The Applications Engineer will be involved throughout the entire product lifecycle, from new ... Cascode devices * Perform comprehensive experimental validation and data analysis of product ...

Kodak

Quality Specialist

Rochester, NY

$31 - $33.50/hr

... as medical devices or pharmaceuticals. Working knowledge of GMP requirements, quality ... Experience supporting validation, laboratory operations, inspections, and quality system ...

Ralliant

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 ...

Ralliant

Junior Controls Engineer

Fairport, NY · On-site

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

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Validation Engineer Medical Devices information

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

As of Jul 18, 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 job?

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 in the Validation Engineer Medical Devices position, and why are they important?

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:
Validation Engineer Medical Devices jobs near you
Compliance Engineer II

Compliance Engineer II

Bausch + Lomb

Rochester, NY • On-site

$65K - $100K/yr

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Posted 27 days ago

Bausch & Lomb rating

8.6

Company rating: 8.6 out of 10

Based on 39 frontline employees who took The Breakroom Quiz

27th of 528 rated manufacturers

Job description

Bausch + Lomb (NYSE/TSX: BLCO) is a leading global eye health company dedicated to protecting and enhancing the gift of sight for millions of people around the world-from the moment of birth through every phase of life. Our mission is simple, yet powerful: helping you see better, to live better.
Our comprehensive portfolio of over 400 products is fully integrated and built to serve our customers across the full spectrum of their eye health needs throughout their lives. Our iconic brand is built on the deep trust and loyalty of our customers established over our 170-year history. We have a significant global research, development, manufacturing and commercial footprint of approximately 13,000 employees and a presence in approximately 100 countries, extending our reach to billions of potential customers across the globe. We have long been associated with many of the most significant advances in eye health, and we believe we are well positioned to continue leading the advancement of eye health in the future.
The Compliance Engineer II will provide technical support of Departmental Technical Documentation activities and the development, implementation and effectiveness of Development Process Engineering's (DPE's) procedures and systems for compliance to the quality directives. This includes but is not limited to gap assessments of directives and DPE's processes and procedures, training, procedure effectiveness, metrics for tracking performance, qualification and validation support of equipment, facilities and software, conducting risk assessments, technical writing and electronic filing and storage of information, support internal audits and corrective actions.
Responsibilities:
  • Support Process Engineering Lab Quality Directives gap analysis and closure plan execution.
  • Perform risk assessments, investigations, documentation and procedure updates, qualification writing and execution.
  • Drive effort to manage DPE's SOPs to ensure GMP, FDA, and ISO compliance.
  • Support Compliance and Documentation Systems for DPE (Global Document Management System for protocols/reports and procedures; CATSWeb for non-conformances and CAPAs; Compliance Wire Learning
  • Management System for training; Kintana for change control, conduct risk assessments as they pertain to Quality System compliance.
  • Support systems for PMs, Calibration, Environmental Monitoring, and storage of clinical trial materials and products.
  • Manage and maintain the Master Validation plan for the qualification and requalification of equipment, facilities and software.

Requirements:
  • Bachelors Degree in Science/Engineering strongly preferred and/or certification as a Quality Engineer.
  • 3+ years' experience with medical devices and/or clean room environment compliance regulations with Quality Engineering experience strongly desired
  • Specialized Training: ISO-9000, GMP, medical device manufacturing experience, technical writing, equipment and software qualification documentation, Lean/Six sigma
  • Special Skills: Computer competent with Microsoft Office suite; ability to learn specific software systems utilized in B&L's growing Quality Systems (Documentum, Kintana, CATSWeb).
  • Ability to develop working relationships with various internal core competencies and work as a team member.
  • Active participation in Process and Design FMEA activities
  • Strong Communication, Organization, Report Writing skills

Preferences:
  • Regulated Medical Device or Pharma industry
  • Use and knowledge of Lean and DFSS tools and software

We offer competitive salary & excellent benefits including:
• Medical, Dental, Eye Health, Disability and Life Insurance begins on your hire date
• 401K Plan with company match and ongoing company contribution
• Paid time off - vacation (3 weeks - prorated upon hire), floating holidays and sick time
• Employee Stock Purchase Plan with company match
• Employee Incentive Bonus
• Tuition Reimbursement (select degrees)
• Ongoing performance feedback and annual compensation review
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.
For U.S. locations that require disclosure of compensation, the starting pay for this role is between $65,000.00 and $100,000.00. The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors.
U.S. based employees may be eligible for short-term and/or long-term incentives. They may also be eligible to participate in medical, dental, vision insurance, disability and life insurance, a 401(k) plan and company match, a tuition reimbursement program (select degrees), company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive sick time, floating holidays and paid vacation.
Job Applicants should be aware of job offer scams perpetrated through the use of the Internet and social media platforms.
To learn more please read Bausch + Lomb's Job Offer Fraud Statement.
Our Benefit Programs: Employee Benefits: Bausch + Lomb
Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.

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About Bausch & Lomb

Sourced by ZipRecruiter

Bausch + Lomb (NYSE/TSX: BLCO) is a leading global eye health company dedicated to protecting and enhancing the gift of sight for millions of people around the world--from the moment of birth through every phase of life. Our mission is simple, yet powerful: helping you see better, to live better. Our comprehensive portfolio of over 400 products is fully integrated and built to serve our customers across the full spectrum of their eye health needs throughout their lives. Our iconic brand is built on the deep trust and loyalty of our customers established over our nearly 170-year history. We have a significant global research, development, manufacturing and commercial footprint of approximately 12,500 employees and a presence in approximately 100 countries, extending our reach to billions of potential customers across the globe. We have long been associated with many of the most significant advances in eye health, and we believe we are well positioned to continue leading the advancement of eye health in the future.

Industry

Medical equipment and supplies manufacturing

Company size

10,000+ Employees

Headquarters location

Bridgewater, NJ, US

Year founded

1853

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