Senior Scientist, Design Verification & Biocompatibility

Role details

About BioDevek

BioDevek is a medical device startup developing biomaterial-based solutions for hemostasis in endoscopic and minimally invasive procedures. Our lead product, GastroShield, is a sprayable, biocompatible hydrogel designed to rapidly and safely control gastrointestinal bleeding and protect internal wounds.

We are advancing toward our first regulatory submission and entering a period of growth. This is an opportunity to join a small, hands-on team and play a direct role in bringing a novel device to the clinic.

The Role

As we move toward our 510(k) submission, we are adding a senior scientist to plan, execute, and report the verification, biocompatibility, and material characterization studies that support it. You will work closely with our product development, polymer chemistry, device engineering, and regulatory teams, and with external test labs, CROs, and CDMOs.

Key Responsibilities

• Plan and execute design verification studies for the hydrogel and finished device: protocols, test methods, acceptance criteria, execution, and reports
• Lead chemical characterization under ISO 10993-18, including extractables/leachables study design, and support toxicological risk assessments under ISO 10993-17
• Develop the biocompatibility evaluation plan and justifications under ISO 10993-1, and manage testing with external labs
• Assess the impact of sterilization and aging on material properties and performance, including stability studies that support shelf-life claims
• Develop, validate, and transfer analytical and test methods (e.g., HPLC, GPC, FTIR, rheology, mechanical testing)
• Support design validation activities, including preclinical studies, by defining material-related endpoints and sample requirements
• Manage CRO and test-lab relationships: scoping, quotes, study oversight, and data review
• Write technical reports and test summaries for design history files and regulatory submissions
• Help establish test-method and documentation practices aligned with design controls and our quality system

Qualifications

• Relevant industry experience will be valued above any academic qualification
• Degree in chemistry, polymer science, materials science, biomedical engineering, or a related field
• 5+ years of hands-on industry experience in medical devices or combination products
• Experience executing design verification for at least one product that reached regulatory submission (510(k), De Novo, or PMA)
• Hands-on experience with ISO 10993 biocompatibility strategy, chemical characterization, and E&L studies
• Experience writing protocols and reports under design controls (21 CFR 820 / ISO 13485)
• Strong analytical chemistry background (HPLC, GC-MS/LC-MS familiarity a plus) and understanding of polymer degradation
• Experience managing external CROs and test labs
• Excellent documentation, data interpretation, and technical writing skills
• Comfortable working hands-on in a fast-paced startup environment

Nice to have

• Experience with hydrogels, absorbable or sprayable biomaterials, or GI/endoscopic devices
• Familiarity with sterilization validation (EtO, radiation) and packaging/shelf-life testing (ISO 11607, ASTM F1980)
• Experience preparing responses to FDA questions on biocompatibility or testing

We are not working with recruiters or agencies for this role.

• BioDevek is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.