About this opportunity
TYBR Health lists this Senior Product Development Engineer opportunity in houston, Texas. Review the employer’s description below for duties, qualifications and application requirements.
Job description
TYBR Health is seeking a Senior Product Development Engineer to join our growing team in Houston. This role will play a key part in advancing TYBR Health’s medical device portfolio through product design and development, verification and validation, design optimization, and commercialization.
The ideal candidate is a hands-on engineer who is comfortable working independently, solving complex technical problems, and collaborating across R&D, Quality, Manufacturing, and external partners in a fast-paced medical device startup environment.
What You’ll Do
Location: Houston, TX | In-Person
TYBR Health is seeking a Senior Product Development Engineer to join our growing team in Houston. This role will play a key part in advancing TYBR Health’s medical device portfolio through product design and development, verification and validation, design optimization, and commercialization.
The ideal candidate is a hands-on engineer who is comfortable working independently, solving complex technical problems, and collaborating across R&D, Quality, Manufacturing, and external partners in a fast-paced medical device startup environment.
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 Health
TYBR 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.
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Worksite address
houston, TX, 77246, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.