Product Development Engineer

Product Development Engineer at Kerecis is part of a small but seasoned team responsible for developing and commercializing next‑generation wound, burn, and surgery products. This full‑time, in‑office role reports to the Director of Research & Product Development.

• Apply foundational engineering principles to develop and test new product and technology concepts through the 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 activities, including test method development, execution, and reporting.
• Run product feasibility and pre‑clinical tests in‑house and manage outsourcing to third‑party facilities.
• Write and revise protocols, data collection forms, and reports.
• Communicate project progress in weekly meetings using presentation tools.
• Monitor and scan for technologies and manufacturing processes of value to the business.
• Additional tasks and responsibilities as assigned.

• 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 (Word, Excel, PowerPoint).
• Ability to interact with multidisciplinary colleagues in a team environment.
• Organizational and record‑keeping skills.
• Excellent communication skills (oral & written) with strong presentation technique.

• Graduate degree in an engineering discipline (e.g., biomedical, mechanical, materials science, chemical) required.
• 5+ years full‑time experience in product development in the medical device industry.
• Prior experience in FDA and/or ISO‑regulated product development (21 CFR 820 and ISO 13485).
• Experience planning, conducting, and reporting on verification and validation tests.
• Experience with design of experiments, test method development, statistical analysis techniques, and data analysis tools.

This job description is intended to set forth the core functions required for this position and describe the general nature of the work to be performed. It may not contain a comprehensive inventory of all duties, responsibilities, and qualifications required of employees to do this job. Job duties, responsibilities and activities may change or be supplemented at any time as necessary.

Kerecis is an Equal Opportunity Employer.