Product Development Engineer

Job Description

Job Description

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

Education & Experience

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.