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DEKA Research and Development
Manchester, NH | Full Time
$91k-108k (estimate)
3 Months Ago
Product Safety Test Engineer
$91k-108k (estimate)
Full Time | Scientific Services 3 Months Ago
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DEKA Research and Development is Hiring a Product Safety Test Engineer Near Manchester, NH

Looking for an experienced Product Safety Engineer to evaluate medical devices within our Product Safety Lab. The lab has full capability to test to the IEC 60601-1 and its related collateral standards. There is internal EMC capability as well. This person will support device design teams during concept and development with technical input and preliminary testing. Towards the end of development IEC 60601 TRFs will need to be generated for inclusion in an FDA 510k submittal.How you will make an impact:
  • Work closely with project teams to become familiar with the operation and intended use of the medical devices being evaluated
  • Collaborate with project teams to steer product designs and risk management approach toward standards compliance 
  • Provide design support during all phases of development and recommend appropriate investigational testing and design changes
  • Understand and interpret safety standards as they apply to DEKA devices and communicate to the project team
  • Author/review test cases and compliance test reports
  • Work with project teams to determine applicable operating and configuration modes for evaluation and testing
  • Conduct testing using internal work instructions and test standards
  • Record test data using good documentation practices
  • Contribute to design failure investigations and root-cause analyses as needed, making recommendations for design changes needed for compliance
  • Coordinate and oversee testing with contract test laboratories
  • Participate in the continued improvement of the Product Safety Lab including better efficiency and the expansion into new standards and test methods
  • Keep current with the latest FDA Guidelines and standards as they apply to DEKA devices
  • Maintain test equipment, lab supplies and a clean workspace
Skills you will need to be successful in this role:
  • 1 – 2 years of experience in a laboratory setting
  • BS degree in electrical, biomedical, mechanical engineering or other relevant field
  • Experience with general lab equipment such as DMM, oscilloscopes, and power supplies
  • Ability to work as part of an interdisciplinary team
  • Self-motivated and able to self-prioritize
  • Ability to clearly communicate verbally and in writing
  • Preferred Skills:
    • Familiarity with IEC 60601 collateral and particular standards
    • Experience with Risk Management and ISO 14971
    • Proficiency in electrical circuit analysis with an understanding of transformers, insulation and power electronics
    • Experience with applying knowledge of industry standards such as IEC 62368-1, IEC 62133-2, and 61010-1
    • Experience with technical writing

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.

Job Summary

JOB TYPE

Full Time

INDUSTRY

Scientific Services

SALARY

$91k-108k (estimate)

POST DATE

02/29/2024

EXPIRATION DATE

05/26/2024

WEBSITE

dekaresearch.com

HEADQUARTERS

MANCHESTER, NH

SIZE

500 - 1,000

FOUNDED

1982

CEO

DEAN KAMEN

REVENUE

$50M - $200M

INDUSTRY

Scientific Services

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About DEKA Research and Development

DEKA is one of the leading research and development companies in the country and is the birthplace of some of the most innovative and life-changing products of our time. For over thirty years, DEKA Research & Development Corp. has made Manchester, New Hampshire home. Located about an hour from Boston, the beach, and the mountains, we are situated in the beautiful and historic Amoskeag Millyard buildings located in downtown Manchester. DEKA continues to be a place where no idea seems too big and where creativity and crazy cool gizmos reign supreme. The engineers, technicians, machinists, design...ers and all of the other folks who make up DEKA are some of the most creative and innovative professionals you could ever hope to meet. It's a place where one crazy idea can end up being the next greatest invention. At DEKA we embrace the spirit of innovation and constantly aim to turn the impossible into a reality. DEKA is filled with people who are driven to be among the best and brightest in their field of work. Its a concentrated bunch of really smart thinkers, doers and problems solvers, who are driven to using innovative design solutions and state-of-the-art technology to improve lives. We all see endless possibilities in the power of technology to do good. Employees have the opportunity to work on diverse projects that have a positive, enduring impact on millions of people worldwide. We are growing! We're always seeking passionate individuals to join our growing team of evolved thinkers. More
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