Senior Product Development Engineer

What You’ll Do: Develop and execute verification and validation (V&V) plans, assembly strategies, and test methods Create product specifications, drawings, and manufacturing/R&D work instructions Design test fixtures and controlled test methods to support product development, regulatory submissions, and manufacturing scale-up Conduct testing on prototypes and final products and analyze resulting data Prepare technical reports supporting regulatory filings, product certification, design transfer, and risk assessments Troubleshoot assembly and manufacturing issues and perform root cause analysis Develop and document in-process testing methods Author and maintain design history files (DHF), risk management documentation, DFMEAs, PFMEAs, and test protocols Collaborate with R&D, Quality, Manufacturing, suppliers, and contract manufacturers on design transfer and process validation Lead or support CAPAs and root cause investigations Develop and maintain project timelines for product development initiatives Support supplier qualification, component testing, material selection, and manufacturing partner evaluation Participate in regulatory audits, compliance reviews, and continuous improvement initiatives Contribute to technical presentations, training materials, grant applications, and other product development initiatives as needed These responsibilities are taken directly from the provided job description.

What We’re Looking For: Bachelor’s degree with 7+ years of relevant experience, or Master’s degree with 5+ years of relevant experience, in Biomedical Engineering, Mechanical Engineering, or a related field Medical device product development experience, including design controls and regulatory compliance Experience developing and executing verification and validation testing Proficiency in 3D CAD software such as SolidWorks Hands-on experience with mechanical testing, prototyping, and material characterization Strong technical writing skills, including test protocols, technical reports, regulatory documentation, and design specifications Strong problem-solving skills and the ability to work independently Excellent communication skills Proficiency with Microsoft Word, Excel, and PowerPoint Experience with ISO 13485, ISO 14971, FDA 21 CFR Part 820, CAPA, DFMEA/PFMEA, contract manufacturers, additive manufacturing, and rapid prototyping is preferred. About TYBR HealthTYBR Health is at the forefront of ECM manufacturing for post-surgical complications. We work with leading researchers, clinicians, and business partners to develop safe and effective products designed to improve patient outcomes and quality of life. This is a high-visibility position with the opportunity to take ownership of projects across multiple areas of the organization and gain experience that can be difficult to obtain within larger companies. This position is in-person in Houston, TX. TYBR Health is an Equal Opportunity Employer and is committed to providing an inclusive and respectful workplace.