Senior Test Engineer - medical device or pharmaceutical products

Job Description

Job Description

InnoTECH Staffing is looking to hire a Senior R&D Test Engineer for a product development company in Southern, New Hampshire. Ideal candidate should have medical device and/or pharma experience (Class II or III exp)

This is onsite 5 days a week and candidate must be a US Citizen or Greencard Holder.

Responsibilities:

• Writing test plans, test procedures and other activities involving performance, durability, and reliability assessments
• Understanding of 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 Senior Test Engineer:

• BS in Biomedical, Mechanical and/or Robotics/ Automation Engineering
• 3+ years' experience testing electro-mechanical devices (medical devices or pharma devices preferred)
• Must have laboratory/ wet lab skills and experience
• Must have fluid system handling experience
• 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

Preferred 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

This is onsite in Manchester, NH