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 AccountabilityApply 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 leadsMaintain accurate and detailed documentation throughout all phases of product developmentContribute technical content for regulatory submissions (e.g., 510(k), IDE, CE marking) with oversightCollaborate with Quality, Regulatory, and Manufacturing teams to ensure design outputs meet compliance, usability, and manufacturability requirementsSupport the translation of customer and clinical needs into design inputs and product specificationsAssist with process development, scale-up, and technology transfer activities in collaboration with manufacturing and development leadsParticipate in risk management activities, including hazard identification, analysis, and documentationDesign, perform, and document laboratory experiments, methods development, and product testing with defined objectivesSupport verification and validation (V&V) activities, including test execution and reportingConduct 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 reportsCommunicate project status and technical results in team and project meetingsSupport monitoring of emerging technologies and manufacturing processes relevant to current projectsKerecis 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 policiesOther job duties as assignedBasic QualificationsBachelor's degree in Biomedical, Mechanical or Chemical Engineering or equivalent3+ years of full-time experience in a product development role within the medical device industryExperience working in FDA- and/or ISO-regulated medical product development environmentsExperience supporting verification and validation testing, including execution and documentationFamiliarity with design of experiments, test method development, basic statistical analysis, and data analysis toolsPreferred QualificationsSolid foundation in engineering principles; exposure to biomaterials, wound dressings, or tissue regeneration is a plusBase Salary Range: $90,000 - $120,000This 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.#J-18808-Ljbffr