BioTissue Holdings
Engineer I, Product Development
West Miami, Miami-Dade County
Sponsorship not specified$69k-$86kDetected 2 days ago
Data AnalysisComplianceProduct ManagementSupply ChainProcess ImprovementGMPFDA RegulatoryMedical DevicesSPSSProblem SolvingWriting
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15Unrated
Cap-exempt (no lottery)0
Sponsors this role0
Entry-level history0
PERM / green-card track0
Lottery odds (Level I)39
Fits your clock70
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About the role
- Evaluate and qualify alternative materials, components, and suppliers to mitigate supply chain risks.
- Participate in verification and validation testing, including generation and execution of test protocols and reports.
- Contribute to continuous improvement initiative and knowledge management to enhance development efficiency.
Responsibilities
- The Engineer I provides product and process engineering support throughout the product's lifecycle to meet requirements of Good Tissue, Manufacturing and Laboratory Practices (GTP/GMP/GLP).
- Support design control activities including risk management, verification and validation testing.
- Design, develop, and implement engineering change requests (CRs) to improve product performance, manufacturability, quality, reliability, or component availability.
- Collaborate with cross functional teams to support technology transfer and design transfer activities.
- Support investigations and documentation of product or process performance issues.
- Support internal and external audits, including FDA inspections, ISO 13485, and notified body audits.
- Maintain Risk Management Files throughout the product lifecycle, including the development, review, and revision of applicable documentation in compliance with ISO 14971.
- Lead root cause investigations for product failures, customer complaints, nonconformances, CAPAs, and manufacturing issues using structured problem-solving methodologies (e.g., DMAIC, Fishbone, 5 Whys)
- Perform routine testing, data collection, and statistical analysis.
Requirements
- Ability to multi-task, setting priorities effectively to produce quality work in a fast-paced professional environment.
- Bachelor's degree in biomedical, biotechnology, chemical or related engineering field.
- Ability to work in laboratory, office, and cleanroom environments
Skills
- Strong organization skills with attention to detail.
Compensation
- $69k-$86k
Benefits
- Maintain Design and Development File (DDF), Medical Device File (MDF), technical documentation, and engineering records in compliance with quality system requirements.
- Tuition Reimbursement and Professional Development Support
Company info
- About BioTissue & our Culture At BioTissue, we transform the gift of life by sharing miracles.
- We are a diverse community, where talent and teamwork are core to who we are.
- Company-Paid Basic Life and AD&D Insurance
Equal opportunity
- BioTissue is committed to fostering a workplace where everyone feels valued, respected, and empowered to contribute.
- We welcome applicants from diverse backgrounds and experiences and are proud to be an Equal Opportunity Employer.
- Employment decisions are based on qualifications, merit, and business needs, without regard to any legally protected characteristic.
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