Medical Device Engineer II: Product Development

BioTissue Holdings Inc; Miami (FL); On-site; USD 76,000 - 95,000; Full time

Benefits offered by this job

Medical, Dental, Vision insurance

HSA and FSA

401(k) retirement plan

Life and AD&D insurance

Disability coverage

EAP

Pet insurance

Paid time off

Parental leave

FMLA eligibility

Tuition reimbursement

Performance-based incentives

Equity or stock programs

Job summary

BioTissue Holdings Inc is seeking an Engineer II in Miami to support product development for medical devices in accordance with QMS, focusing on design controls, risk management, and regulatory requirements. You will work cross-functionally to ensure documentation, verification and validation, and smooth transfer to manufacturing.

The role requires 2-4 years of relevant experience in the medical device or biotech sector, with strong technical writing and statistical analysis skills and

Qualifications

• Bachelor’s degree in biomedical, biotechnology, chemical or related engineering field (Master’s preferred).
• Experience working within a regulated Quality Management System (QMS).
• Experience supporting FDA 510(k) submissions.

Responsibilities

• Execute and maintain product development activities per design controls and regulatory requirements.
• Develop and maintain design and development documentation (requirements, inputs/outputs, specs, V&V, design reviews).
• Coordinate cross-functional product development and resolve technical issues affecting timelines.
• Support design transfer to GMP manufacturing and QbD activities for biologics.
• Apply ISO 14971 risk management and maintain risk documentation (PHA, FMEA).
• Participate in investigations related to nonconformances and CAPAs.

Skills

Design controls

Regulatory knowledge

V&V principles

Technical writing

Statistical analysis

DOE

Minitab

SPSS

Project management

Education

Bachelor’s degree in biomedical, biotechnology, chemical or related engineering field

Master’s degree (preferred)

Tools

Minitab

SPSS

Job description

BioTissue Holdings Inc is seeking an Engineer II in Miami to support product development for medical devices in accordance with QMS, focusing on design controls, risk management, and regulatory requirements. You will work cross-functionally to ensure documentation, verification and validation, and smooth transfer to manufacturing.

The role requires 2-4 years of relevant experience in the medical device or biotech sector, with strong technical writing and statistical analysis skills and