Biomedical Device Engineer II: Design Controls & Risk Mgmt

BioTissue, Inc.; Miami, Northern (FL, KY); Hybrid; USD 76,000 - 95,000; Full time

Benefits offered by this job

Health Insurance

401(k) Retirement Plan

Paid Time Off

Job summary

BioTissue, Inc. in Miami, FL is seeking an Engineer II to support and execute medical device product development under regulatory requirements.

You will collaborate with Quality, Regulatory Affairs, Operations, and Manufacturing to ensure design controls, risk management, verification/validation, and successful transfer to manufacturing. The role requires a Bachelor's degree in biomedical, biotechnology, chemical, or related engineering field, 2–4 years of experience in a regulated setting,

Qualifications

• Bachelor’s degree in biomedical, biotechnology, chemical or related engineering field.
• 2–4 years of relevant experience in the medical device, biotechnology, or pharmaceutical sector.
• Experience working within a regulated Quality Management System.
• Experience supporting FDA 510(k) submissions.
• Experience applying ISO 14971 risk management.

Responsibilities

• Support product development activities for medical devices.
• Develop and maintain design controls documentation.
• Coordinate cross-functional product development activities.
• Assist with design transfer to GMP manufacturing.
• Apply QbD principles to product and process development.
• Support FDA 510(k) submissions.

Skills

Design controls

FDA 510(k)

Quality systems

Statistical analysis

DOE

Technical writing

Cross-functional collaboration

Education

Bachelor’s degree in biomedical/biotechnology/chemical or related engineering

Master’s degree preferred

Tools

Minitab

SPSS

Job description

BioTissue, Inc. in Miami, FL is seeking an Engineer II to support and execute medical device product development under regulatory requirements.

You will collaborate with Quality, Regulatory Affairs, Operations, and Manufacturing to ensure design controls, risk management, verification/validation, and successful transfer to manufacturing. The role requires a Bachelor's degree in biomedical, biotechnology, chemical, or related engineering field, 2–4 years of experience in a regulated setting,