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 scalabilityTesting & Validation :
Develop and execute test methods, validation protocols to confirm product functionality, safety and performanceAnalyze test data, investigate failures, and implement design improvementsEnsure all products meet quality standards and customer expectationsProduction and Scalability Evaluation :
Assess manufacturing processes, materials and equipment for suitability, efficiency and cost-effectivenessCollaborate with Operations and Manufacturing to optimize production methodsCross-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 executionSupport product positioning, messaging, and internal / external communications with technical inputDocumentation & Reporting :
Author detailed protocols, reports, and technical documents to support design history files and regulatory submissionsRegularly report progress and highlight any risks or issues to manager or stakeholdersRegulatory 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 fieldMaster's of Science in Engineering is preferredExperience :
Minimum of 5 years in the medical device, pharmaceutical, biotech or regenerative medicine industriesHands-on product development and testing experience in regenerative medicine or a closely related fieldExperience specifically with tissue-based or biologic products (preferred)Skills & Competencies :
Strong analytical and problem-solving skills with the ability to make data-driven decisionsExtensive knowledge of the Medical Device / Biotech / Pharma / Regenerative Medicine industry, with specific experience in regenerative medicine preferredTissue 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 marketingProven experience in authoring test protocols, executing studies and analyzing / reporting test resultsFamiliarity 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 filesWillingness 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 SalariesHealth, Dental, and Vision InsuranceRetirement PlansTuition ReimbursementGenerous Paid Time OffEmployee Assistance ProgramNo premium paymentsBioLab 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.