Description
Job Title
Product Development Engineer I
Department
Product Development
Reports To
Director of Product Development
Location
Mesa, AZ (Onsite)
FLSA Classification
Exempt
Salary Range
$75,000-$85,000
Company Summary
BioLab Holdings, Inc. and its affiliates companies ("the Company") is a biotechnology company committed to raising the standard of caring by developing, manufacturing, and commercializing breakthrough products with patient care in mind. At the heart of our work is a mission to optimize the standard of wound care through innovations grounded in science, compassion, and collaboration. We support healthcare distributors, providers, and patients worldwide who share our same initiatives to deliver clinical performance and real-world impact.
Position Summary
BioLab Holdings is seeking a motivated and innovative Product Development Engineer I to join our Product Development team. This entry-level role offers an exciting opportunity to contribute to the development of tissue-based products from concept through commercialization while gaining hands-on experience in a highly regulated industry.
Working alongside experienced engineers and cross-functional teams, the Product Development Engineer I will support product research, design, testing, validation, and documentation activities. Success in this role requires strong analytical thinking, attention to detail, curiosity, and a desire to learn and grow in a collaborative environment.
Essential Functions
Research and Product Development Support
• Assist in researching customer needs, emerging technologies, and industry trends to support new product development initiatives.
• Support the evaluation of materials, processes, and technologies for potential product applications.
• Research technical literature, scientific publications, patents, and competitive technologies to support innovation activities.
• Contribute technical ideas and engineering recommendations during concept development and design reviews.
Product Design and Prototyping
• Assist with designing, developing, and refining product concepts and prototypes.
• Perform engineering analyses and evaluations to support design decisions.
• Support prototype fabrication, testing, and iterative design improvements.
Testing and Validation
• Execute laboratory testing, validation protocols, and engineering studies while assisting in the design of experiments and interpretation of results.
• Collect, analyze, and summarize experimental data and test results.
• Apply basic statistical methods to analyze experimental data and support engineering decisions.
• Assist with troubleshooting product performance issues and identifying root causes.
• Support the implementation of design improvements based on testing outcomes.
• Participate in product risk assessments and support the implementation of risk mitigation activities.
Manufacturing and Process Support
• Collaborate with Operations and Manufacturing teams to support product transfer and scale-up activities.
• Assist in evaluating manufacturing processes, materials, and equipment for product feasibility and efficiency.
• Participate in continuous improvement initiatives related to product design and production processes.
Cross-Functional Collaboration
• Work closely with Product Development, Quality, Regulatory Affairs, Manufacturing, and Project Management teams to support development projects.
• Participate in project meetings and provide technical updates on assigned activities.
• Support department initiatives and special projects as assigned.
Documentation and Technical Reporting
• Maintain accurate engineering records, laboratory notebooks, test reports, and technical documentation.
• Assist in preparing protocols, reports, work instructions, and design history documentation.
• Support documentation activities required for regulatory compliance and product development milestones.
• Assist in developing Design History Files (DHF), Design Inputs, Design Outputs, Risk Management documentation, and other Design Control deliverables, as applicable.
Regulatory and Quality Compliance
• Perform work in compliance with applicable FDA, ISO, cGMP, and Company quality system requirements.
• Follow established procedures, laboratory practices, and safety protocols.
• Support audit readiness and documentation accuracy initiatives.
This job description is not intended to be an exhaustive list of all duties, responsibilities, or
qualifiations associated with the job. Other duties may be assigned.
Competencies
• Project Execution: Supports small projects or defined project workstreams of limited-to-moderate complexity under the guidance of senior team members.
• Planning and Organization: Develops and maintains project schedules, tracks assigned deliverables and dependencies and communicates potential timeline concerns.
• Technical and Industry Knowledge: Applies foundational knowledge of engineering principles and the biotechnology or medical device product lifecycle when completing assigned product development activities.
• Risk Identification and Escalation: Identifies technical, quality, scheduling, and project risks within assigned responsibilities and promptly escalates concerns to management or appropriate project stakeholders.
• Continuous Improvement: Identifies and recommends practical improvements to technical processes, reporting methods, documentation practices, and project workflows.
• Cross-Functional Collaboration: Coordinates effectively with Product Development, Quality, Regulatory Affairs, Manufacturing, Operations, and Project Management to support alignment on project requirements, deliverables, and timelines.
• Task-Level Leadership and Knowledge Sharing: Provides task-level guidance and shares technical knowledge with interns, coordinators, or peers when appropriate, while seeking direction from more experienced team members as needed.
• Departmental Alignment: Connects assigned projects and development activities to departmental priorities, product development goals, and broader organizational objectives.
Minimum Qualifications
Education: Bachelor's degree in Engineering, Biomedical Engineering, Biological Sciences, Mechanical Engineering, Chemical Engineering, or a related technical discipline required.
Experience:
• Zero to two years of engineering, product development, research laboratory, internship, co-op, or relevant industry experience.
• Demonstrated engineering aptitude through internships, undergraduate research, senior design projects, or equivalent hands-on technical experience.
• Previous experience in medical device, biotechnology, pharmaceutical, regenerative medicine, laboratory, or manufacturing environments preferred.
• Internship, undergraduate research, capstone project, or co-op experience related to product development highly desirable.
Certifications: None required.
Knowledge, Skills, and Abilities
• Strong analytical, problem-solving, and troubleshooting skills.
• Basic understanding of engineering design principles and scientific methodologies.
• Ability to collect, analyze, and interpret technical data.
• Familiarity with laboratory testing methods, experimental design, and data analysis techniques.
• Effective written and verbal communication skills.
• Ability to manage multiple tasks and prioritize work in a fast-paced environment.
• Strong attention to detail and commitment to quality.
• Proficiency with Microsoft Office Suite and technical documentation practices.
• Ability to work effectively both independently and within cross-functional teams.
• Knowledge of FDA requirements, ISO 13485, cGMP, tissue-based products, biologics, or medical device regulations is a plus.
• Experience with statistical analysis software, data visualization tools, or engineering software preferred but not required.
• Willingness to learn new technologies, processes, and regulatory requirements.
Physical Requirements
• Ability to sit, stand, walk, bend, reach, and lift up to 25 pounds on an occasional basis.
• Ability to work in laboratory, manufacturing, and office environments.
• Frequent use of a computer and standard office equipment.
• Ability to wear required personal protective equipment (PPE) and comply with laboratory safety requirements.
Work Environment
Employees in this role may be exposed to environmental, activity-related, and ergonomic hazards throughout the workday. Potential environmental risks include spills, weather-related conditions, inadequate ventilation, extreme heat or cold, poor housekeeping, chemical exposure, and slip, trip, or fall hazards. Activity-related hazards may involve working around heat sources, compressed gases, electrical cords and tools, energized equipment, and possible exposure to contagious diseases or other unforeseen risks.
Ergonomic hazards may include lifting, awkward postures, repetitive motions, and prolonged periods of sitting or standing. Extended workstation use may contribute to back, shoulder, hand, or arm discomfort and eye strain, while prolonged standing may result in strains, sprains, or leg and knee discomfort. Employees must remain aware of workplace conditions, follow applicable safety procedures, promptly address or report hazards, and use required protective equipment to reduce the risk of injury.
Travel Requirements
Ability to travel up to 10% as needed.
What we offer: Looking for a company to work for can be a daunting task, but we believe that we stand out from the rest. Our company offers a positive and inclusive work environment, opportunities for growth and development, and a commitment to work-life balance. Join us and become part of a team that values your contributions and invests in your success.
Employment Statement
The Company is an equal opportunity employer and complies with all applicable federal, state, and local employment laws. Employment decisions are made without regard to race, color, religion, sex,
national origin, age, disability, genetic information, veteran status, sexual orientation, gender identity, or any other status protected by applicable federal, state, or local law.
In accordance with the Americans with Disabilities Act, reasonable accommodations may be made to enable qualified individuals with disabilities to perform essential job functions or participate in the application process. Applicants needing accommodation should contact Human Resources.
Applicants must be legally authorized to work in the United States at the time of hire. The Company participates in employment eligibility verification as required by law.
The salary range for this position represents the anticipated compensation at the time of posting and may vary based on experience, qualifications, and geographic location where applicable.
Employment with the Company is at-will, meaning that either the employee or the Company may terminate employment at any time, with or without cause or notice, subject to applicable law.
Job Title
Product Development Engineer I
Department
Product Development
Reports To
Director of Product Development
Location
Mesa, AZ (Onsite)
FLSA Classification
Exempt
Salary Range
$75,000-$85,000
Company Summary
BioLab Holdings, Inc. and its affiliates companies ("the Company") is a biotechnology company committed to raising the standard of caring by developing, manufacturing, and commercializing breakthrough products with patient care in mind. At the heart of our work is a mission to optimize the standard of wound care through innovations grounded in science, compassion, and collaboration. We support healthcare distributors, providers, and patients worldwide who share our same initiatives to deliver clinical performance and real-world impact.
Position Summary
BioLab Holdings is seeking a motivated and innovative Product Development Engineer I to join our Product Development team. This entry-level role offers an exciting opportunity to contribute to the development of tissue-based products from concept through commercialization while gaining hands-on experience in a highly regulated industry.
Working alongside experienced engineers and cross-functional teams, the Product Development Engineer I will support product research, design, testing, validation, and documentation activities. Success in this role requires strong analytical thinking, attention to detail, curiosity, and a desire to learn and grow in a collaborative environment.
Essential Functions
Research and Product Development Support
• Assist in researching customer needs, emerging technologies, and industry trends to support new product development initiatives.
• Support the evaluation of materials, processes, and technologies for potential product applications.
• Research technical literature, scientific publications, patents, and competitive technologies to support innovation activities.
• Contribute technical ideas and engineering recommendations during concept development and design reviews.
Product Design and Prototyping
• Assist with designing, developing, and refining product concepts and prototypes.
• Perform engineering analyses and evaluations to support design decisions.
• Support prototype fabrication, testing, and iterative design improvements.
Testing and Validation
• Execute laboratory testing, validation protocols, and engineering studies while assisting in the design of experiments and interpretation of results.
• Collect, analyze, and summarize experimental data and test results.
• Apply basic statistical methods to analyze experimental data and support engineering decisions.
• Assist with troubleshooting product performance issues and identifying root causes.
• Support the implementation of design improvements based on testing outcomes.
• Participate in product risk assessments and support the implementation of risk mitigation activities.
Manufacturing and Process Support
• Collaborate with Operations and Manufacturing teams to support product transfer and scale-up activities.
• Assist in evaluating manufacturing processes, materials, and equipment for product feasibility and efficiency.
• Participate in continuous improvement initiatives related to product design and production processes.
Cross-Functional Collaboration
• Work closely with Product Development, Quality, Regulatory Affairs, Manufacturing, and Project Management teams to support development projects.
• Participate in project meetings and provide technical updates on assigned activities.
• Support department initiatives and special projects as assigned.
Documentation and Technical Reporting
• Maintain accurate engineering records, laboratory notebooks, test reports, and technical documentation.
• Assist in preparing protocols, reports, work instructions, and design history documentation.
• Support documentation activities required for regulatory compliance and product development milestones.
• Assist in developing Design History Files (DHF), Design Inputs, Design Outputs, Risk Management documentation, and other Design Control deliverables, as applicable.
Regulatory and Quality Compliance
• Perform work in compliance with applicable FDA, ISO, cGMP, and Company quality system requirements.
• Follow established procedures, laboratory practices, and safety protocols.
• Support audit readiness and documentation accuracy initiatives.
This job description is not intended to be an exhaustive list of all duties, responsibilities, or
qualifiations associated with the job. Other duties may be assigned.
Competencies
• Project Execution: Supports small projects or defined project workstreams of limited-to-moderate complexity under the guidance of senior team members.
• Planning and Organization: Develops and maintains project schedules, tracks assigned deliverables and dependencies and communicates potential timeline concerns.
• Technical and Industry Knowledge: Applies foundational knowledge of engineering principles and the biotechnology or medical device product lifecycle when completing assigned product development activities.
• Risk Identification and Escalation: Identifies technical, quality, scheduling, and project risks within assigned responsibilities and promptly escalates concerns to management or appropriate project stakeholders.
• Continuous Improvement: Identifies and recommends practical improvements to technical processes, reporting methods, documentation practices, and project workflows.
• Cross-Functional Collaboration: Coordinates effectively with Product Development, Quality, Regulatory Affairs, Manufacturing, Operations, and Project Management to support alignment on project requirements, deliverables, and timelines.
• Task-Level Leadership and Knowledge Sharing: Provides task-level guidance and shares technical knowledge with interns, coordinators, or peers when appropriate, while seeking direction from more experienced team members as needed.
• Departmental Alignment: Connects assigned projects and development activities to departmental priorities, product development goals, and broader organizational objectives.
Minimum Qualifications
Education: Bachelor's degree in Engineering, Biomedical Engineering, Biological Sciences, Mechanical Engineering, Chemical Engineering, or a related technical discipline required.
Experience:
• Zero to two years of engineering, product development, research laboratory, internship, co-op, or relevant industry experience.
• Demonstrated engineering aptitude through internships, undergraduate research, senior design projects, or equivalent hands-on technical experience.
• Previous experience in medical device, biotechnology, pharmaceutical, regenerative medicine, laboratory, or manufacturing environments preferred.
• Internship, undergraduate research, capstone project, or co-op experience related to product development highly desirable.
Certifications: None required.
Knowledge, Skills, and Abilities
• Strong analytical, problem-solving, and troubleshooting skills.
• Basic understanding of engineering design principles and scientific methodologies.
• Ability to collect, analyze, and interpret technical data.
• Familiarity with laboratory testing methods, experimental design, and data analysis techniques.
• Effective written and verbal communication skills.
• Ability to manage multiple tasks and prioritize work in a fast-paced environment.
• Strong attention to detail and commitment to quality.
• Proficiency with Microsoft Office Suite and technical documentation practices.
• Ability to work effectively both independently and within cross-functional teams.
• Knowledge of FDA requirements, ISO 13485, cGMP, tissue-based products, biologics, or medical device regulations is a plus.
• Experience with statistical analysis software, data visualization tools, or engineering software preferred but not required.
• Willingness to learn new technologies, processes, and regulatory requirements.
Physical Requirements
• Ability to sit, stand, walk, bend, reach, and lift up to 25 pounds on an occasional basis.
• Ability to work in laboratory, manufacturing, and office environments.
• Frequent use of a computer and standard office equipment.
• Ability to wear required personal protective equipment (PPE) and comply with laboratory safety requirements.
Work Environment
Employees in this role may be exposed to environmental, activity-related, and ergonomic hazards throughout the workday. Potential environmental risks include spills, weather-related conditions, inadequate ventilation, extreme heat or cold, poor housekeeping, chemical exposure, and slip, trip, or fall hazards. Activity-related hazards may involve working around heat sources, compressed gases, electrical cords and tools, energized equipment, and possible exposure to contagious diseases or other unforeseen risks.
Ergonomic hazards may include lifting, awkward postures, repetitive motions, and prolonged periods of sitting or standing. Extended workstation use may contribute to back, shoulder, hand, or arm discomfort and eye strain, while prolonged standing may result in strains, sprains, or leg and knee discomfort. Employees must remain aware of workplace conditions, follow applicable safety procedures, promptly address or report hazards, and use required protective equipment to reduce the risk of injury.
Travel Requirements
Ability to travel up to 10% as needed.
What we offer: Looking for a company to work for can be a daunting task, but we believe that we stand out from the rest. Our company offers a positive and inclusive work environment, opportunities for growth and development, and a commitment to work-life balance. Join us and become part of a team that values your contributions and invests in your success.
Employment Statement
The Company is an equal opportunity employer and complies with all applicable federal, state, and local employment laws. Employment decisions are made without regard to race, color, religion, sex,
national origin, age, disability, genetic information, veteran status, sexual orientation, gender identity, or any other status protected by applicable federal, state, or local law.
In accordance with the Americans with Disabilities Act, reasonable accommodations may be made to enable qualified individuals with disabilities to perform essential job functions or participate in the application process. Applicants needing accommodation should contact Human Resources.
Applicants must be legally authorized to work in the United States at the time of hire. The Company participates in employment eligibility verification as required by law.
The salary range for this position represents the anticipated compensation at the time of posting and may vary based on experience, qualifications, and geographic location where applicable.
Employment with the Company is at-will, meaning that either the employee or the Company may terminate employment at any time, with or without cause or notice, subject to applicable law.