Product Safety Test Engineer Position Available In Hillsborough, New Hampshire
Tallo's Job Summary: Looking for a Product Safety Test Engineer with 3+ years of experience in a Test Engineer role. Responsibilities include collaborating with project teams, conducting testing, generating TRFs for FDA submissions, and ensuring compliance with safety standards. Preferred skills include familiarity with IEC 60601 standards and ISO 14971. DEKA Research & Development is hiring for this position.
Job Description
Job Description:
Looking for an experienced Product Safety Engineer to evaluatemedical devices within our Product Safety Lab. The lab has fullcapability to test to the IEC 60601-1 and its related collateralstandards. There is internal EMC capability as well. This personwill support device design teams during concept and developmentwith technical input and preliminary testing. Towards the end ofdevelopment
IEC 60601
TRFs will need to be generated for inclusionin an FDA 510k submittal.
How you will make an impact as a
ProductSafety Test Engineer:
Work closely with project teams to become familiar with theoperation and intended use of the medical devices beingevaluated Collaborate with project teams to steer product designs andrisk management approach toward standards compliance Provide design support during all phases of development andrecommend appropriate investigational testing and designchanges Understand and interpret safety standards as they apply to DEKAdevices and communicate to the project team Author/review test cases and compliance test reports Work with project teams to determine applicable operating andconfiguration modes for evaluation and testing Conduct testing using internal work instructions and teststandards Record test data using good documentation practices Contribute to design failure investigations and root-causeanalyses as needed, making recommendations for design changesneeded for compliance Coordinate and oversee testing with contract testlaboratories Participate in the continued improvement of the Product SafetyLab including better efficiency and the expansion into newstandards and test methods Keep current with the latest FDA Guidelines and standards asthey apply to DEKA devices Maintain test equipment, lab supplies and a cleanworkspaceSkills you will need to be successful: 3+ years’ experience in a Test Engineer role with ProductSafety- related experience preferred 1 – 2 years of experience in a laboratory setting BS degree in electrical, biomedical, mechanical engineering orother 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
PreferredSkills:
Familiarity with
IEC 60601
collateral and particularstandards Experience with Risk Management and
ISO 14971
Proficiency in electrical circuit analysis with anunderstanding of transformers, insulation and powerelectronics Experience with applying knowledge of industry standards suchas
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 historicAmoskeag Millyard once housed the largest textile mills in theworld. It is now home to DEKA Research & Development, where we aretaking the same innovation and cutting-edge technology into themodern age. Behind DEKA’s brick walls sits a team of professionals who striveto make a difference every day through thoughtful engineering,design, and manufacturing. Here at DEKA, some of the mostinnovative and life-changing products of our time are created, andnew ideas are always welcome and explored. Required Preferred Job Industries Other
