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Product Development Engineer

2 months ago

Minneapolis, United States Kerecis LLC Full time
Job DescriptionJob DescriptionDescription:

Job Description: 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.

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

Essential Functions

· Monitor/Scan for technologies and manufacturing processes of value to the business

· Apply foundational engineering principles to develop and test new product concepts

· Participate in ideation sessions, voice of customer research, and innovation sprints

· Maintain detailed documentation throughout all phases of product development

· Run product feasibility tests in-house and manage outsourcing to other third-party facilities

· Write engineering test plans, design requirements, design failure mode and effect analysis (DFMEA)

· Build engineering 2D drawings & 3D parts/assemblies in SolidWorks (or other design software) to drive prototype development activities

· Work with Project managers, mechanical engineers, industrial designers, and others to prepare necessary technical documentation and work instructions in support of the company’s stage-gate process, compliant with ISO 13485 and 21 CFR 820

Requirements:

Requirements


Competencies

· Strong work ethic to deliver high-quality products on time and within budget

· Self-motivation

· Demonstrated leadership; ability to motivate and guide 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


Education & Experience


· B.S. required in an engineering discipline (e.g., biomedical, mechanical, industrial, packaging)

· 3-5 years' experience in a 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 planning, conducting and reporting on verification and validation tests

· Experience using design of experiments, test method development, statistical analysis techniques, and data analysis tools


Anticipated travel: 10%


This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time. Kerecis is an equal opportunity employer.