R&D Validation Engineer
Ideal candidates will exhibit, or have the willingness to develop, the following qualities:
- Strategic thinker who can translate client needs into actionable value-added projects/results
- Understands the competitive landscape of the medical device, pharmaceutical, and biotechnology industry
- Willing to work hands on, assist with building client libraries, learn from a mentor and become a mentor for others.
- Draws insights from projects and supplemental research to help drive new and existing growth.
- Ensures activities are efficient, optimized, and client-centric.
- Highly motivated and organized
- Curious and adaptable - has the ability to transform knowledge into actionable activities
- Able to produce results in a fast paced, collaborative environment
Azzur personnel are expected to live up to our core values at all times and exhibit a high level of integrity and personal responsibility, especially when interacting with our valued clients. The following is a short list of the typical responsibilities and deliverables of any given project. The level of knowledge expected will be commensurate with level of incoming experience.
- Responsible for process development, characterization and validation of devices and sub-assemblies.
- Implement process improvement strategies to improve quality, reliability, and/or reduce cost. Drive continuous improvement activities using a variety of continuous process improvement tools, including but not limited to Six Sigma, SPC, DOE, etc
- Development and/or review of design drawings and specification documents.
- Design, build, and execute testing of components or sub-assemblies, document, and present test plans to a broader audience.
- Support quality management to ensure that products and methods and design controls comply with regulatory expectations and the associated Quality Management Systems.
- Design and install quality control process sampling systems, procedures, and statistical analysis techniques.
- Develop and validate test and inspection methods including the design and fabrication of tools and assemblies needed to support the test/inspection method.
- Create, test, and/or improve products by developing, or supporting the development, of experiments and tests (including writing and executing protocols), analyze results, make recommendations, and develop reports, based on sound engineering principles and practices.
- Prepare risk management files and identify mitigations, drive risk management activities from product conception through commercialization.
- Lead design transfer to manufacturing, provide training to manufacturing operators and colleagues for process, product, and/or equipment.
- Manage Internal and external suppliers’ design, manufacturing, and qualification activities.
- Manage projects that require leading/collaborating with cross-functional teams, developing test plans, leading root cause analysis, and participating in investigations. Make presentations to internal/external clients, customers, vendors, and senior management.
- Develop, plan and track risk assessments for device manufacturing non-conformances, change controls, and implement appropriate CAPAs. Support process improvement plans and strategies that are designed to mitigate the risks identified.
- Support or lead product quality and compliance issues (e.g, CAPA, non-conformances, audit observations). Analyze results, make recommendations, and develop reports.
- BS in Engineering, Science or equivalent technical degree.
- 2-5 years’ experience in a regulated, manufacturing environment within the
- Understanding of medical device design controls (ISO 13485); lead design reviews and ensure on-time completion of Design Control deliverables.
- Experience in the areas of design documentation (URS, FS, DS and other engineering specifications) Validation (IQ, OQ, PQ, PV, CV, CSV, etc.), Quality Systems (Change Control, Non-Conformances, Requalification, etc), and Process Excellence Methodologies (Six-Sigma, Lean, etc.).
- Excellent written and verbal communication skills; excellent technical writing skills.
- Strong interpersonal skills and the ability to work in a team environment.
- Ability to work effectively in a fast paced multitasking environment.
- Working knowledge of FDA and cGMP regulations and documentation practices.
- Proficient in Microsoft Word, Excel, PowerPoint.
- Working for multiple clients through out the region.
Azzur Group is an equal opportunity employer and promotes diverse cultures, ethnicities, gender, and ages in our workplace. We believe that promoting diversity plays an important role in developing top-quality talent, fostering greater innovation and creativity, and enhancing our relationships with customers and the communities in which we operate.