Senior Test Engineer
DEKA
- Manchester, NH
- Permanent
- Full-time
- 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
- 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
- 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