Product Development Engineer I - Medical Devices

BioTissue Holdings Inc; Miami (FL); On-site; USD 68,980 - 86,226; Full time

Benefits offered by this job

Medical Insurance

401(k) Plan

Paid Time Off

Equity/Stock Program

Tuition Reimbursement

Parental Leave

Job summary

BioTissue Holdings Inc. in Miami, FL is seeking an Engineer I to provide product and process engineering support across the lifecycle of medical devices, focusing on risk management files and quality system compliance.

You will lead investigations, drive continuous improvement, collaborate across functions including regulatory, manufacturing, and supplier teams, and support audits such as FDA inspections to ensure uninterrupted product supply.

Qualifications

• Bachelor’s degree in a biomedical/biotech/chemical engineering field.
• 1+ year of relevant experience in the medical device/biotech/pharma sector.
• Knowledge of cGMP and design controls.
• Experience with risk management tools (FMEA, hazard analysis).
• Strong data analysis skills (Minitab, SPSS) and problem solving.

Responsibilities

• Support design control activities including risk management and verification/validation testing.
• Lead root cause investigations for product failures and CAPAs.
• Develop engineering change requests to improve performance and manufacturability.
• Conduct routine testing, data collection, and statistical analysis.
• Assist in supplier evaluation and documentation.
• Support audits including FDA inspections and ISO 13485.

Skills

CGMP knowledge

Risk management

Data analysis software

Organization skills

Communication skills

Multitasking

Education

Bachelor's in biomedical/biotech/chemical eng

Job description

BioTissue Holdings Inc. in Miami, FL is seeking an Engineer I to provide product and process engineering support across the lifecycle of medical devices, focusing on risk management files and quality system compliance.

You will lead investigations, drive continuous improvement, collaborate across functions including regulatory, manufacturing, and supplier teams, and support audits such as FDA inspections to ensure uninterrupted product supply.