Kerecis · 6 hours ago
Product Development Engineer
Minneapolis, MN
Full-time
Onsite
Senior Level
5+ years expKerecis is a company focused on the development and commercialization of next-generation medical products. The Product Development Engineer will be responsible for applying engineering principles to develop and test new product concepts, ensuring compliance and usability throughout the product development process.
Health CareManufacturingMedicalMedical Device
Responsibilities
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
Qualification
Required
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
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
Company
Kerecis
Kerecis is a commercial stage company pioneering the use of fish skin and fatty acids in cellular-therapy and regenerative-medicine
501-1000 employees
H1B Sponsorship
Kerecis has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (9)
2024 (4)
2020 (1)
Funding
Current Stage
Late StageTotal Funding
$123.61MKey Investors
Silicon Valley BankKIRKBITechnology Development Fund
2023-07-07Acquired
2022-07-21Debt Financing· $15M
2022-07-20Series D· $60M
Leadership Team
Gudmundur Fertram Sigurjonsson
Founder, President & CEO
Gunnar Jóhannsson
SVP of Research & Development
Recent News
Morningstar.com
2025-12-26
Business Wire
2025-12-17
Morningstar.com
2025-10-06
Company data provided by crunchbase