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Product Development Engineer
2 months ago
The Product Development Engineer at Kerecis LLC is a key member of our team responsible for the development and commercialization of our next-generation medical products. As a seasoned professional in the medical device industry, you will be part of a small but experienced team of medical device professionals.
Key Responsibilities- Technology Scanning and Monitoring: Identify and evaluate technologies and manufacturing processes that can benefit our business.
- Product Development and Testing: Apply engineering principles to develop and test new products and technology concepts through our stage-gate process.
- Documentation and Reporting: Maintain detailed documentation throughout all phases of product development and design, perform, and report on laboratory experiments, methods development, and product testing.
- Product Feasibility and Pre-clinical Tests: 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.
- Engineering Test Plans and Design Requirements: Write engineering test plans, design requirements, design failure mode and effect analysis (DFMEA).
- Technical Documentation and Work Instructions: Work with project managers, engineers, specialists, and others to prepare necessary technical documentation and work instructions in support of our stage-gate process, compliant with ISO 13485 and 21 CFR 820.
- Project Progress Communication: Clearly and efficiently communicate project progress using presentation tools in weekly group meetings.
- Engineering Expertise: Proficiency in an engineering role in the field of medical device.
- Work Ethic and Leadership: Strong work ethic to deliver high-quality products on time and within budget, demonstrated leadership, and ability to motivate and mentor others to meet objectives and drive actions to closure.
- Technical Skills: 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, and communication skills (oral and written) with excellent presentation technique.
- Education: Bachelor's degree from an accredited college or university required in an engineering discipline (e.g., biomedical, mechanical, materials science, chemical, and correlates).
- Experience: 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), 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%
