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Product Development Engineer
Product Development EngineerBioLab Holdings, Inc. • Mesa, AZ, United States
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Product Development Engineer

Product Development Engineer

BioLab Holdings, Inc. • Mesa, AZ, United States
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  • [job_card.full_time]
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Description

Job Title : Product Development Engineer

Company Summary :

BioLab Holdings is a regenerative health company focused on providing innovative solutions that encourage the body to heal naturally. Our mission is to raise the standard of caring. Since its founding, BioLab Holdings has experienced explosive growth and is actively developing new technologies to innovate, improve customer experience, and expand its market share within the wound management space. We are seeking individuals who are passionate about making a difference in the work they do and will help support our company's mission.

Reports To : Chief Operations Officer (COO) with close coordination with Project Management Leadership on day-to-day project planning and cadence.

Job Overview :

We are seeking a highly analytical and innovative Product Development Engineer to join our Product Development Team. In this role, you will lead the end-to-end development of tissue-based products-from initial concept and design through validation and transfer into production.

At our core, we operate on principles of ingenuity and creativity, applying inventive problem-solving to complex challenges while working within rigorous regulatory frameworks. Success in this position requires a strong combination of technical expertise, creative thinking, and cross-functional collaboration to deliver products that are safe, effective, compliant, and aligned with customer needs.

Essential Functions :

Research & Innovation :

  • Conduct in-depth research regarding customer needs and industry trends to identify potential product ideas and needs
  • Translate research insights into innovative product design concepts aligned with business strategy.

Product Design & Prototyping :

  • Design, develop, and refine product concepts and prototypes.
  • Evaluate design feasibility, performance and scalability
  • Testing & Validation :

  • Develop and execute test methods, validation protocols to confirm product functionality, safety and performance
  • Analyze test data, investigate failures, and implement design improvements
  • Ensure all products meet quality standards and customer expectations
  • Production and Scalability Evaluation :

  • Assess manufacturing processes, materials and equipment for suitability, efficiency and cost-effectiveness
  • Collaborate with Operations and Manufacturing to optimize production methods
  • Cross-Functional Collaboration :

  • Partner with R&D, Quality, Regulatory and Marketing teams to align product design with technical, compliance, and commercial goals, along with partnership with Project Management leadership for planning, prioritization and execution
  • Support product positioning, messaging, and internal / external communications with technical input
  • Documentation & Reporting :

  • Author detailed protocols, reports, and technical documents to support design history files and regulatory submissions
  • Regularly report progress and highlight any risks or issues to manager or stakeholders
  • Regulatory Compliance :

  • Ensure product development activities comply with FDA, ISO, cGMP, and other applicable regulatory requirements.
  • This job description is not intended to be an exhaustive list of all duties, responsibilities, or qualifications associated with the job. Other duties may be assigned.
  • Qualifications : Education :

  • Bachelor's Degree in Engineering, Biological Sciences, or a related field
  • Master's of Science in Engineering is preferred
  • Experience :

  • Minimum of 5 years in the medical device, pharmaceutical, biotech or regenerative medicine industries
  • Hands-on product development and testing experience in regenerative medicine or a closely related field
  • Experience specifically with tissue-based or biologic products (preferred)
  • Skills & Competencies :

  • Strong analytical and problem-solving skills with the ability to make data-driven decisions
  • Extensive knowledge of the Medical Device / Biotech / Pharma / Regenerative Medicine industry, with specific experience in regenerative medicine preferred
  • Tissue handling, biomaterial characterization and process validation / statistical tools (DOE, Minitab, etc.)
  • Ability to work collaboratively with cross-functional teams, including R&D, quality, regulatory and marketing
  • Proven experience in authoring test protocols, executing studies and analyzing / reporting test results
  • Familiarity with regulatory requirements and quality standards relevant to tissue / biologic products (e.g., FDA, ISO, cGMP)
  • Strong technical writing skills to support regulatory submissions and design history files
  • Willingness to travel up to 20% of the time for supplier visits, audits, etc.
  • Location : On-Site - Mesa, AZ

    What we offer :

    We are committed to fostering a culture built on collaboration, inclusivity, and respect. Ingenuity and creativity are central to our operating principles, driving us to solve complex problems with innovative thinking while maintaining the highest regulatory standards.

    Our employees benefit from opportunities for professional growth and development, along with a strong commitment to supporting work-life balance. By joining our team, you will contribute to meaningful work, be recognized for your impact, and have access to resources that enable long-term success.

    Total Rewards Package :

  • Competitive Salaries
  • Health, Dental, and Vision Insurance
  • Retirement Plans
  • Tuition Reimbursement
  • Generous Paid Time Off
  • Employee Assistance Program
  • No premium payments
  • BioLab Holdings is an Equal Opportunity employer and does not discriminate based on race, ancestry, color, religion, sex, age, marital status, sexual orientation, national origin, medical condition, disability, veteran status, gender identity, or any other basis protected by law.

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