Description
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 position.
Essential Functions
- Monitor/Scan for technologies and manufacturing processes of value to the business
- Apply foundational engineering principles to develop and test new products and technology concepts through the entire company’s stage-gate process
- Maintain detailed documentation throughout all phases of product development
- Design, perform and report on laboratory experiments, methods development and product testing
- Run product feasibility and pre-clinical tests in-house and manage outsourcing to other third-party facilities. Responsible for writing and revising protocols, data collection forms, and reports
- Write engineering test plans, design requirements, design failure mode and effect analysis (DFMEA)
- Work with Project managers, engineers, specialists, 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
- Clearly and efficiently communicate project progress using presentation tools in weekly group meetings
- Other tasks and responsibilities as assigned
Requirements
Competencies and Attributes
- Proficiency in engineering role in the field of medical device
- Strong work ethic to deliver high-quality products on time and within budget
- Self-motivated
- 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
Education & Experience
- Bachelor’s degree from an accredited college or university required in an engineering discipline (e.g., biomedical, mechanical, materials science, chemical, and correlates)
- 10-15 years' experience in a product development role in the medical device industry
- Familiarity with the conduct of preclinical biocompatibility and animal studies is a plus.
- 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 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 LLC is an equal opportunity employer.
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