Engineer I, Product Development

BioTissue Holdings Inc•Miami, FL

6d•$68,980 - $86,226•Onsite

About The Position

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. Here, you are EMPOWERED to do the work you love, be yourself, and make an impact. Resilient and committed to our vision, we embrace challenges, celebrate courage, and take great pride in our work to create life-changing products. Purpose led us here. Passion and legacy keep us going. 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). This role primarily contributes to the development and maintenance of medical device Risk Management Files throughout the product lifecycle by ensuring risk management activities and documentation are maintained in compliance with applicable standards and company procedures. This role also focuses on maintaining product quality, reliability, regulatory compliance, and manufacturing efficiency by leading engineering investigations, implementing design changes, resolving technical issues, and driving continuous improvement initiatives. This role collaborates closely with technical services, manufacturing, quality, donor services, regulatory, commercial, medical affairs and external suppliers to ensure uninterrupted product supply while meeting applicable regulatory and quality standards.

Requirements

Knowledge of cGMP and design controls (e.g., FDA 21 CFR Part 820, Part 210/211, Part 1270/1271, ISO 13485, ICH).
Knowledge of medical device risk management principles, including ISO 14971/ISO 13485, risk analysis methodologies, and Risk Management File documentation.
Exposure to data analysis software (Minitab, SPSS or similar)
Strong organization skills with attention to detail.
Effective communicator and eager to learn in a regulated environment.
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.
1 or more years of relevant experience in the medical device, biotechnology, or pharmaceutical sector.

Nice To Haves

Experience with verification and validation of medical devices.
Familiarity with risk management tools (e.g., FMEA, hazard analysis).
Familiarity with biocompatibility, sterilization methods, and packaging validation.
Experience with technical writing or lab documentation.

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 (e.g., DMAIC, Fishbone, 5 Whys)
Design, develop, and implement engineering change requests (CRs) to improve product performance, manufacturability, quality, reliability, or component availability.
Perform routine testing, data collection, and statistical analysis.
Evaluate and qualify alternative materials, components, and suppliers to mitigate supply chain risks.
Generate supplier and supply documentation, user requirements specifications, supplier change notification, gap analysis.
Maintain Design and Development File (DDF), Medical Device File (MDF), technical documentation, and engineering records in compliance with quality system requirements.
Collaborate with cross functional teams to support technology transfer and design transfer activities.
Participate in verification and validation testing, including generation and execution of test protocols and reports.
Support investigations and documentation of product or process performance issues.
Support internal and external audits, including FDA inspections, ISO 13485, and notified body audits.
Contribute to continuous improvement initiative and knowledge management to enhance development efficiency.
Participate in process improvement projects, including the evaluation and introduction of new equipment, technologies, and tools to improve workflows.
Participate in risk assessments (e.g., FMEA, hazard analysis) and establish control strategies consistent with QbD, ICH Q9 and ISO 14971 principles.
Maintain Risk Management Files throughout the product lifecycle, including the development, review, and revision of applicable documentation in compliance with ISO 14971.
Perform other duties and projects as assigned.