Senior Test Engineer - medical device or pharmaceutical products
About The Position
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
Requirements
- 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
- US Citizen or Greencard Holder
Nice To Haves
- 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
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
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
