Senior Validation Engineer

iSpace, Inc.; City of Rochester (NY); On-site; USD 120,000 - 140,000; Full time

Job summary

A leading medical device company is seeking a Staff Instrument Reliability Verification and Validation Engineer in Rochester, NY. You will manage engineering teams responsible for the verification and validation of complex medical devices, ensuring adherence to FDA regulations. Candidates should have 15+ years in the medical device industry, with significant management experience. The role includes mentorship and oversight of design control documentation while maintaining product integrity. Competitive salary and benefits offered.

Qualifications

• 15+ years experience in a medical device environment, with at least 10 years leading large teams.
• Strong knowledge of IEC 62304, ISO 13485, and FDA QSR.

Responsibilities

• Manage two teams for reliability and V&V planning.
• Drive design control and ensure regulatory compliance.
• Document and manage system software defects.
• Mentor and develop team members to enhance growth.

Skills

Problem-solving skills

Attention to detail

Organizational skills

Communication skills

People management skills

Ability to work cross-functionally

Education

B.S. or M.S. Degree in a relevant field

Tools

Software configuration management tools

Defect tracking tools

Job description

This range is provided by iSpace, Inc.. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$120,000.00/yr - $140,000.00/yr

Staff Instrument Reliability Verification and Validation Engineer

Full-Time Employment with CLIENT

Salary $120k to $140k + Benefits

Job Description

Candidates Must sit in Rochester, NY (100% on-site)

Candidates ideally have led and/or management experience – being able to work cross functionally is important.

As we continue to grow as clients, we are seeking a Staff Instrument Reliability Verification and Validation Engineer to help with formal verification and validation of complex medical devices under the regulations of the FDA. The individual will lead and be part of an engineering team that is responsible for requirements‑based manual test case design and execution of test procedures in a BL2 lab environment. The team is highly collaborative and will require regular interactions in formal reviews, test planning activities, and working with software development and partners to reproduce and verify system defects.

Responsibilities

• Manage two separate Teams, oversee reliability and V&V planning, resourcing, and schedules to ensure on‑time completion of milestones
• Drive design control efforts, including writing instrument design control documentation and reviewing as necessary (Plans, Protocols & Reports) to ensure regulatory compliance
• Evaluate project risks and issues and provide recommendations to resolve challenges impeding success
• Design, develop, code, test, and debug system software serving as a technical bridge between software Development and V&V
• Ensure rigorous adherence to design control documentation and internal procedures for post‑launch activities, maintaining regulatory compliance and product quality standards
• Develop requirements‑based manual test procedures
• Assess requirements for testability and determine the best test approach
• Compile and analyze test results
• Document and manage system software defects
• Participate in regular off‑hour meetings with the business partner
• Understand project goals and timelines, and provide technical leadership to ensure product launch success
• Ensure optimal resource allocation and timely project completion while maintaining quality standards
• Mentor and develop team members to help them grow professionally
• Provide critical oversight in resolving field issues and maintaining product integrity throughout the lifecycle
• Perform other work‑related duties as assigned

Individual (Qualifications)

• B.S. or M.S. Degree in Computer Science, Chemistry, Biochemistry, Biology, Engineering, or related discipline required.
• 15+ years experience, preferably a minimum of 10 years leading a large team in a medical device environment.
• Excellent problem‑solving and troubleshooting, and V&V skills to eliminate risks, attention to detail.
• Strong knowledge of software configuration management tools, defect tracking tools, and peer review.
• Understanding of IEC 62304, ISO 13485, ISO/EN ISO 14971, and FDA QSR or equivalent FDA software development requirements.
• Strong organizational & communication skills, people management skills, and ability to manage multiple projects, prioritize tasks, and manage competing priorities effectively.
• Experience in product development and experimental design.
• Ability to work within cross‑functional teams.
• Professional, confident, mature, desire to succeed, and a self‑motivated and proactive orientation.
• Ability to participate in planning and managing projects.
• Strong working knowledge of product development tools and processes (e.g., Design Input, Design Output, Verification & Validation, Product Risk Management).
• Strong knowledge of related quality systems regulations and processes.
• Appropriate computer skills (e‑mail, word processing, statistical, spreadsheet, and graphing software).
• Knowledge of Application life cycle management (Agile method preferred).
• Understand and execute software test cycle.
• Coach and mentor junior staff, provide technical leadership to cross‑functional project teams.
• 10% travel includes airplane, automobile travel, and overnight hotel.
• Not currently eligible for visa sponsorship.

Key Working Relationships

Internal Partners:

• Software Development, Software Integration, Marketing, Quality, and Project Management

External Partners:

• Software Development partners

If you're interested in above role please send me your updated resume to [e-mail]