Product Development Engineer

Kerecis•Minneapolis, MN

6d•Onsite

About The Position

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.

Requirements

Proficiency in engineering role in the field
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

Nice To Haves

Strong foundation in engineering principles with applied knowledge of biomaterials, wound dressings, and/or tissue regeneration is a plus

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