Medical Device Engineer

Job Description

We are seeking a qualified Medical Device Engineer with experience in regulated medical device product development, engineering studies, and medical device standards. The ideal candidate will have strong technical writing and communication skills, knowledge of quality and regulatory requirements, and experience applying statistical methods to engineering studies.

Required Qualifications

• Bachelor's degree in Engineering with at least 3 years of relevant experience, or equivalent experience.

• Strong written and verbal communication skills.

• Proficiency in Microsoft Office Suite.

• Working knowledge of medical device standards and regulations, including:

  • 21 CFR Part 820 QSR (2024)

  • ISO 13485

  • ISO 14971

  • MDD and MDR

  • IEC 62366-1

  • ISO/IEC 27001

  • BS EN 62304

• Working knowledge of statistics applied to engineering studies, including sample size rationale, DOE, and hypothesis testing.

  Preferred Qualifications

  • 3 5 years of full-time engineering experience in regulated medical device product development.

  • Degree from an ABET-accredited institution, or global equivalent, in Mechanical Engineering, Biomedical Engineering, Bioengineering, Materials Science, Materials Engineering, Chemical Engineering, Polymer Engineering, or a related engineering discipline.

  • Experience with orthopedic implants, medical software, biomaterials, antimicrobial technologies, wound management, coatings, or local drug delivery.

  • Familiarity with drug-device combination products and Software as a Medical Device (SaMD).

  • Experience with Minitab and statistical analysis.