At BDC Laboratories, the business problem is to ensure that every piece of equipment meets the rigorous demands of biotech studies, and to drive innovation in the biotech industry, specifically in cardiovascular technologies such as endovascular stents, prosthetic heart valves, and catheters.
Requirements
- Familiarity with quality system requirements like ISO 17025 and 21 CFR Part 58
- Knowledge of ISO 13485 and 21 CFR Part 820
- Proficiency with a Windows environment (Word and Excel)
- Understanding of statistical analyses and technical regulations
- Experience with quality system requirements including ISO 17025 and 21 CFR part 58
- Experience in 21 CFR Part 820 and Part 11, ISO 13485 and other relevant international standards
- Ability to read, analyze, and interpret technical procedures and governmental regulations
Responsibilities
- Assess the suitability of equipment for data acquisition, ensuring compliance with protocol specifications
- Guarantee all equipment is designed for optimal performance, adequately cleaned, and meticulously maintained
- Establish innovative test methods, preparing meticulous protocols, and maintaining a contamination-free environment
- Verify and analyze experimental data, enhancing the integrity of research
- Support the Quality Management System and participate in audits
- Set an exemplary standard for colleagues
- Lead the way in driving innovation in a fun, high-performance culture
Other
- Minimum of a Bachelor’s Degree in an engineering field and 4 years of experience; or minimum of a Master’s Degree in an engineering field and 2 years of experience; or minimum of a Bachelor’s Degree in a science-based field and 6 years of relevant experience; or an Associate Degree with a minimum of 10 years of relevant experience
- Strong verbal and written communication skills
- Ability to mentor and manage fellow engineers
- Good interpersonal and leadership skills
- Ability to effectively present information and respond to questions from managers and team members
