Product Development Engineer

Description

The Product Development Engineer at Kerecis is part of a small but seasoned team of medical device professionals responsible for the development and commercialization of the Company’s next-generation products across its wound, burn and surgery market. 

The Product Development Engineer is based in a Kerecis office and reports to the Director of Research & Product Development. This is a full-time, in-office position.

Essential Functions

• 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
• Support risk management activities
• Design, perform and report on laboratory experiments, methods development and product testing
• Contribute to verification and validation (V&V) activities, including test method development, execution, and reporting
• Run product feasibility and pre-clinical tests in-house and manage outsourcing to other third-party facilities.
• Write and revise protocols, data collection forms, and reports
• Clearly and efficiently communicate project progress using presentation tools in weekly group meetings
• Monitor/Scan for technologies and manufacturing processes of value to the business
• Additional tasks and responsibilities as assigned

Requirements

Competencies & Attributes

• 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 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
• Strong aptitude with Microsoft Office products, such as Word, Excel and PowerPoint
• Ability to interact with multidisciplinary colleagues in a team environment
• Organizational and record keeping skills
• Communication skills (oral and written), with excellent presentation technique

Education & Experience

• 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 
• Prior work history in FDA and/or ISO-regulated medical product development (21 CFR 820 and ISO 13485)
• 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

Anticipated travel: 10%

This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time. Kerecis is an equal opportunity employer.