Job Information
DEKA Research & Development Biocompatibility Test Engineer in Manchester, New Hampshire
We are seeking a Biocompatibility Test Engineer to join our growing team of dedicated technologists. This position will play a key role in supporting DEKA’s biocompatibility/sterility process across many projects, working with project cross-functional teams to provide biocompatibility, sterilization and other design safety deliverables in compliance with ISO 10993 and other regulatory guidelines.
How you will make an impact:
As a Biocompatibility Test Engineer you will focus on the biocompatibility and toxicological evaluation of designs required for approvals and patient safety
Working with team members and stakeholders, you will design and implement effective biocompatibility and sterilization testing strategies, plans and test procedures in accordance with FDA requirements, internal SOPs and standards
Coordinate and facilitate testing related to sterile barrier integrity (packaging), sterilization validation, endotoxin, toxicology, drug stability and compatibility, particulate, and reprocessing validations
Liaise with internal resources (engineering, regulatory, quality, clinical and manufacturing) and external resources, developing and coordinating test strategies with Contract Research Organizations (CROs) to ensure appropriate planning and execution of required testing
Review test results to ensure design requirements are met
Utilize problem solving skills and technical knowledge to troubleshoot testing anomalies
Coordinate toxicological risk assessments with toxicologists for a variety of medical devices across the company
Evaluate new designs and changes in design per organizational risk management practices to ensure effective, safe and compliant devices
Manage multiple projects requiring biocompatibility and sterilization evaluations ensuring timely completion of required tasks to meet project schedules
Maintain a knowledge of applicable external standards and regulatory requirements for the biological safety of medical devices and mentor the development of this knowledge in others
Support Regulatory Affairs on preparing information related to FDA-related correspondences
To succeed in this role, you will need the following skills and experience:
Bachelor’s degree in an engineering or scientific discipline such as Biomedical Engineering, Biology, Biochemistry, Chemistry, or Microbiology
1-3 years of experience in the medical device industry
Attention to detail necessary to maintain the required documentation
Excellent technical writing, verbal communication, and organizational skills
Experience writing and reviewing test procedures and reports
Good interpersonal skills and demonstrated success working in a collaborative environment
Ability to work independently with minimal supervision
Experience with using good laboratory practices (GLP)
About DEKA:
One hour from the beach, Boston, and the mountains, the historic Amoskeag Millyard once housed the largest textile mills in the world. It is now home to DEKA Research & Development, where we are taking the same innovation and cutting-edge technology into the modern age.
Behind DEKA’s brick walls sits a team of professionals who strive to make a difference every day through thoughtful engineering, design, and manufacturing. Here at DEKA, some of the most innovative and life-changing products of our time are created, and new ideas are always welcome and explored.
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