Product Development Engineer I — Medical Device Risk & QA

BioTissue Ocular; Miami (FL); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Medical, Dental, and Vision Insurance

401(k) Retirement Savings Plan

Paid Time Off

Parental Leave

Job summary

BioTissue is seeking an Engineer I to provide product and process engineering support across the lifecycle, focusing on risk management and compliance with GTP/GMP/GLP. You will drive investigations, implement design changes, and lead continuous improvement to ensure quality and supply continuity.

You will collaborate with quality, regulatory, manufacturing, and supplier teams to maintain documentation and support audits, with a strong emphasis on risk assessment and process optimization.

Qualifications

• Knowledge of cGMP and design controls (FDA 21 CFR 820, ISO 13485)
• Understanding of ISO 14971 risk management and FMEA/hazard analysis
• Experience with data analysis tools such as Minitab or SPSS

Responsibilities

• Support design control activities including risk management, verification and validation testing.
• Lead root cause investigations for product failures, customer complaints, nonconformances, CAPAs, and manufacturing issues using structured problem-solving methodologies.
• Design, develop, and implement engineering change requests to improve product performance, manufacturability, quality, reliability or component availability.
• Perform routine testing, data collection, and statistical analysis.
• Maintain Design and Development File, Medical Device File and technical documentation per quality system requirements.
• Collaborate with cross-functional teams to support technology transfer and design transfer activities.

Skills

cGMP knowledge

Regulatory compliance

Data analysis

Education

Bachelor’s degree in biomedical/biotech/chemical engineering

Tools

Minitab

SPSS

Job description

BioTissue is seeking an Engineer I to provide product and process engineering support across the lifecycle, focusing on risk management and compliance with GTP/GMP/GLP. You will drive investigations, implement design changes, and lead continuous improvement to ensure quality and supply continuity.

You will collaborate with quality, regulatory, manufacturing, and supplier teams to maintain documentation and support audits, with a strong emphasis on risk assessment and process optimization.