Are you looking to be part of an enthusiastic, driven, passionate and challenging team, who continuously learn from one another? Are you detailed oriented? Imagine what you could do here. At our client you will be part of a team to work on a surgical robot that combines real time data, multi-dimensional imaging and robotics to remove prostate tissue. As our client continues to expand, you will oversee the design quality deliverables for the next generation robotic surgery platform and for our current product generation. You will work with cross functional teams to develop design quality assurance and reliability strategies for worldwide approval in compliance with the company's Quality Management System, 21CFR820, ISO 13485 and other applicable international quality system standards.
CORE RESPONSIBILITIES (Other duties may be required as assigned)
- Support new product development and design changes to existing products in ensuring compliance with company’s Quality System
- Lead Risk Management activities including improving the risk management process and maintenance of the Risk management procedure
- Serve as a technical resource for requirements, risk, verification and validation, process validation, usability, statistical analysis, Design Transfer, etc.
- Support Capital Equipment design development activities primarily focusing on Mechanical design and assess the reliability of new designs.
- Support Program Management with compliance to Design Controls and Risk Management procedures and delivery of robust Design History Files
- Develop and implement product quality plans, risk management plans to ensure high degree of assurance that specific design and processes will consistently and continually produce a product that meets specifications and critical to quality attributes.
- Assist QA department in quality audits including FDA and Notified Body and respond to non-conformities, as necessary.
- Support corrective and preventive action process for design and quality assurance process related CAPA
- Maintain trained status for, and comply with, all relevant aspects of the Quality Management System to ensure product and support regulatory compliance
- Understand and adhere to the EHS policy
QUALIFICATIONS (Education, Experience, Certifications)
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Bachelor’s degree or Master’s degree in, Mechanical or Biomedical Engineering
- Minimum of 5 years of experience working in medical device industry
- Background in electromechanical and software devices
- Must have working knowledge of CFR 820, ISO 13485, ISO 14971, IEC 62304, IEC 62366
- Must have working knowledge of sterilization, biocompatibility, and transit/shelf life standards
- Experience with medical device HW testing (IEC 60601, IEC 60529)
- ASQ CQE, CRE, CSQE, or CQA certification preferred
- Must have a solid understanding of statistical processes and techniques
- Understanding of SW Development Lifecycle, SW Architecture, and Configuration Management
- Must be detail orientated, well organized and have excellent communication skills. Must work well with team
- Must be able to accomplish objectives with minimal supervision
- Must be detail-oriented with strong written and oral communication skills
- Ability to read, analyzes, and interprets general business periodicals, professional journals, technical procedures, or governmental regulations
- Ability to write reports, customer facing correspondence, and procedure manuals
- Experience in conducting product investigations
- Ability to effectively present information and respond to questions from other internal groups, clients, customers, and the general public
- Ability to work with mathematical concepts such as probability and statistical inference
- Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists
- Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form