Kerecis is looking to develop and commercialize next-generation medical device products across its wound, burn, and surgery market
Requirements
- Proficiency in engineering role in the field
- Strong foundation in engineering principles with applied knowledge of biomaterials, wound dressings, and/or tissue regeneration is a plus
- Strong aptitude with Microsoft Office products, such as Word, Excel and PowerPoint
- Experience in planning, conducting and reporting on verification and validation tests
- Experience with design of experiments, test method development, statistical analysis techniques, and data analysis tools
- Prior work history in FDA and/or ISO-regulated medical product development (21 CFR 820 and ISO 13485)
- Experience with biomaterials, wound dressings, and/or tissue regeneration
Responsibilities
- Apply foundational engineering principles to develop and test new product and technology concepts through the entire company’s stage-gate process
- Maintain detailed documentation throughout all phases of product development
- Support preparation of technical content for regulatory submissions (e.g., 510(k), IDE, CE marking)
- Collaborate with Quality, Regulatory, and Manufacturing teams to ensure design outputs meet compliance, usability, and manufacturability requirements
- Translate customer and clinical needs into design inputs and product specifications
- Support process development, scale-up, and technology transfer to manufacturing
- Design, perform and report on laboratory experiments, methods development and product testing
Other
- Graduate degree from an accredited college or university in an engineering discipline (e.g., biomedical, mechanical, materials science, chemical, and correlates) required
- 5+ years full-time experience in product development role in the medical device industry
- Strong work ethic to deliver high-quality products on time and within budget
- Self-motivation
- Demonstrated leadership; ability to motivate and mentor others to meet objectives and drive actions to closure
- Anticipated travel: 10%
