Senior Product Engineer

Auxilium is a biomaterials company developing solutions for skin tissue infections and regeneration. Our platform biomaterial is designed to prevent microbial infections while supporting tissue regeneration. We are setting the stage for the next generation of biomaterials that promote effective healing and improve outcomes for both patients and healthcare professionals.

Our mission is to heal patients from day one by restoring human health.

The role

Auxilium is seeking an exceptional, collaborative, and analytically rigorous Senior Engineer in Product Development to join our pioneering team. The ideal candidate brings deep expertise in biomaterials and tissue engineering, combined with a proven track record operating under design controls in regulated environments. This includes hands‑on ownership of verification and validation (V&V), quality systems, and data‑driven product development using design of experiments (DOE).

We are particularly interested in individuals with experience developing skin substitutes, biologics, regenerative membranes, or advanced wound care products, as well as polymeric or hybrid coatings for hard‑tissue healing and biofilm‑resistant applications.

As a Senior Product Engineer at Auxilium, you will work closely with founders and leadership to translate early‑stage biomaterials innovation into manufacturable, clinically relevant products. You will design and execute robust experimental strategies, drive product performance optimization, and integrate insights across material science, biology, and engineering. This role requires operating seamlessly across the lab, design documentation, and manufacturing environments to deliver products within a rigorous medical device quality and regulatory framework.

Responsibilities

• Lead the design, prototyping, and optimization of biomaterial‑based medical devices for wound healing, infection prevention, medical implants, and bone regeneration.
• Translate user needs and clinical requirements into clear, testable design inputs and engineering specifications.
• Own and execute design controls, including DHF documentation, risk management, and traceability in compliance with FDA and ISO standards.
• Plan and lead verification and validation (V&V) activities, including protocol development, execution, and reporting
• Develop and run material and product testing programs to evaluate performance, stability, and safety in alignment with regulatory requirements.
• Apply DOE and statistical methods to optimize product design and performance.
• Correlate bench, in vitro, and preclinical data to guide design decisions and predict clinical outcomes.
• Integrate manufacturability, quality, and scalability into product design from early development through commercialization.
• Lead design transfer to manufacturing, supporting process development, validation, and scale‑up with internal teams and external partners.
• Collaborate cross‑functionally with R&D, quality, regulatory, clinical, and manufacturing teams to deliver product milestones.
• Serve as a technical lead for external partners, including CROs, CDMOs, and suppliers.

Requirements

• Bachelor’s or advanced degree in Materials Science, Biomedical Engineering, Chemical Engineering, or a related field. Advanced degree preferred.
• 6–12+ years of experience developing medical devices in a regulated environment, with direct ownership of products from concept through design transfer.
• Demonstrated track record of owning design controls end‑to‑end, including DHF creation, risk management (FMEA), and full V&V execution.
• Proven experience translating early‑stage R&D or biomaterials concepts into manufacturable, scalable products.
• Deep expertise in biomaterials, polymers, or soft materials, with strong intuition for structure–property–performance relationships in biological environments.
• Strong command of experimental design and data analysis, including DOE and statistical methods, with a history of driving decisions from complex datasets.
• Experience leading design transfer and manufacturing scale‑up, including process development, validation, and working with external partners (CDMOs/CROs).
• Demonstrated ability to generate high‑quality, audit‑ready technical documentation, including DHF artifacts, test protocols/reports, and regulatory‑supporting materials.
• Familiarity with FDA regulatory pathways (e.g., 510(k)) and experience contributing to or leading technical sections of submissions.
• Strong cross‑functional leadership skills, with the ability to drive alignment across engineering, quality, regulatory, and manufacturing teams.

Bonus Qualifications

• Direct experience developing or commercializing skin substitutes, biologics, advanced wound care products, medical implants, or regenerative tissue technologies.
• Experience supporting or contributing to FDA submissions (e.g., 510(k)), including generation of technical sections and data packages.
• Deep familiarity with bio‑based or natural polymers and processing techniques such as solvent exchange, advanced drying, or coating technologies.
• Hands‑on experience with biofilm models, wound microbiology, or antimicrobial performance testing, including interpretation of biologically complex datasets.
• Experience working with fibrous substrates (woven/non‑woven) and integrating coatings or active materials into scalable product formats.
• Proven experience in design transfer and scale‑up, including collaboration with CDMOs or external manufacturing partners.
• Familiarity with sterilization methods and their impact on material properties and product performance.
• Experience building or refining elements of a quality management system, including SOPs, test methods, and work instructions in a regulated environment.