Senior Test Engineer - electro-mechanical medical device systems validation

ZipRecruiter; Manchester; On-site; GBP 45,000 - 60,000; Full time

Job summary

A dynamic company in the medical device R&D sector is seeking a Senior Systems Validation Engineer to ensure project success through rigorous testing and validation processes. This full-time position requires a solid engineering background and expertise in FDA regulations, offering the chance to work on impactful projects that advance healthcare technology.

Qualifications

• 3+ years' experience testing electro-mechanical medical devices.
• Self-motivated, able to self-prioritize, and excellent communication skills.
• Experience with data and failure analysis, and regulatory knowledge.

Responsibilities

• Writing test plans and procedures for performance and reliability assessments.
• Creating and evaluating test fixtures for product design verification.
• Participating in regulatory agency submissions.

Skills

Knowledge of FDA Quality System Regulations

Problem Solving

Leadership

Communication

Education

BS in Physics, Electrical, Mechanical and/or Biomedical Engineering

Tools

Measurement Instruments

Job description

Job DescriptionJob Description

InnoTECH Staffing is seeking a Senior Systems Validation Engineer to work in a dynamic medical device R&D environment for a company in the Southern, NH area. This is a high visibility role with a direct impact on the success of our projects. It will be a great opportunity to work on some amazing projects that make a positive impact on the world.

This requires being onsite 5 days a week. There is no sponsorship at this time.

How you will make an impact:

• Writing test plans, test procedures and other activities involving performance, durability, and reliability assessments
• Understand device design and core technologies in order to inform test method development
• Determining test coverage for revisions to design
• Creating and evaluating test fixtures needed for product design verification
• Contributing to design failure investigations that may impact Risk Assessment, Hazard Analysis, and FTAs
• Participating and contributing toward regulatory and agency submissions
• Authoring Quality Plans, Test Summaries, and other documents

What you need to be successful:

• BS in Physics, Electrical, Mechanical and/or Biomedical Engineering
• 3+ years' experience testing electro-mechanical medical devices
• Leadership and/or mentoring experience
• Knowledge and deep understanding of engineering fundamentals
• Capability to create and clearly explain team objectives and write procedures for others to follow
• Demonstrated problem solving ability and techniques
• Ability to work as part of an interdisciplinary team
• Self-motivated and able to self-prioritize
• Must have excellent verbal and written communication skills

skills and experience:

• Knowledge of FDA Quality System Regulations (QSRs) and/or ISO 13485, and other medical device industry experience
• Experience with research, development, and product testing
• Experience writing procedures for others to follow
• Experience with data and failure analysis
• Broad measurement instrument knowledge