Product Development Engineer

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. This position will include laboratory work and interacting with suppliers.

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

Major Areas of Accountability

* Apply core engineering principles to support the development and testing of new product and technology concepts through the company's stage-gate process, under guidance from project tech leads

* Maintain accurate and detailed documentation throughout all phases of product development

* Contribute technical content for regulatory submissions (e.g., 510(k), IDE, CE marking) with oversight

* Collaborate with Quality, Regulatory, and Manufacturing teams to ensure design outputs meet compliance, usability, and manufacturability requirements

* Support the translation of customer and clinical needs into design inputs and product specifications

* Assist with process development, scale-up, and technology transfer activities in collaboration with manufacturing and development leads

* Participate in risk management activities, including hazard identification, analysis, and documentation

* Design, perform, and document laboratory experiments, methods development, and product testing with defined objectives

* Support verification and validation (V&V) activities, including test execution and reporting

* Conduct product feasibility and pre-clinical tests in-house and assist with outsourcing activities to third-party facilities, including preparation of protocols, data collection forms, and draft reports

* Communicate project status and technical results in team and project meetings

* Support monitoring of emerging technologies and manufacturing processes relevant to current projects

* Kerecis employees are required to conduct business to the highest ethical and professional standards; comply with applicable laws and regulations, the Advamed Code of Ethics on Interactions with Healthcare Professionals, and company policies

* Other job duties as assigned

Basic Qualifications

* Bachelor's degree in Biomedical, Mechanical or Chemical Engineering or equivalent

* 3+ years of full-time experience in a product development role within the medical device industry

* Experience working in FDA- and/or ISO-regulated medical product development environments

* Experience supporting verification and validation testing, including execution and documentation

* Familiarity with design of experiments, test method development, basic statistical analysis, and data analysis tools

Preferred Qualifications

* Solid foundation in engineering principles; exposure to biomaterials, wound dressings, or tissue regeneration is a plus

Base Salary Range: $90,000 - $120,000

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.

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