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Eurofins · 2 days ago

Senior Product Safety Project Medical Engineer

Boston, MA, USA

Full-time

Onsite

Mid, Senior Level

$100K/yr - $125K/yr

Eurofins Scientific is an international life sciences company providing analytical testing services to ensure product safety and authenticity. The role involves serving as a technical contact for customers, interpreting medical standards for product investigations, and preparing certification reports while managing multiple projects.

BiotechnologyGeneticsHealth CareLife SciencePharmaceutical

Responsibilities

Serve as a customer technical contact

Interpret medical standards and apply the requirements to products under investigation; including but not limited to IEC/EN/AAMI/CSA 60601-1, ISO 14971, IEC 60601-1-6

Create and implement test plans; conduct the required tests in accordance with the applicable standard(s), procedures and ensure results are documented

Ensure that test equipment is calibrated or tested and operates properly

Interface with and update the lab manager

Review files and reports prepared by other project engineers; including but not limited to peer reviews

Conduct preliminary design reviews

Monitor multiple projects

Prepare certification reports and related documents (e.g., approval letters, test report forms, etc.)

Assists department with quoting medical projects

Assist Sales with closing new work

Qualification

Biomedical EngineeringElectrical EngineeringMedical Device CertificationIEC/EN/AAMI StandardsISO 14971Test Plan DevelopmentProfessional DemeanorTeam PlayerPositive Attitude

Required

Support department objectives and company goals

Be a team player

Sustain a positive, enthusiastic and professional attitude

Accommodate requests with a smile and 'let me see what I can do' attitude

Adhere to manager directives

Maintain a professional appearance and demeanor

Candidate will be required to sign a non-compete agreement as part of the offer

Preferred

Four-year engineering college degree – Biomedical or Electrical discipline preferred or three years progress towards four-year degree, or equivalent work experience

Prior experience performing certification for medical devices at another test, inspection and certification laboratory preferred but not required