Medical Device Manufacturing Engineer
Essential Duties and Responsibilities
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.
- Process/Product development, characterization and validation of devices and sub-assemblies.
- Perform Manufacturing Variability analysis on products and processes designed to characterize and reduce variability in manufacturing.
- Perform device modeling and simulation using Material and Solid models supported by FEA simulation.
- Develop test methods using LAA models and a Biostimulator dynamic system to mimic the in vivo.
- Lead projects involving leading/collaborating with cross-functional teams, developing test plans, leading root cause analysis, and participating in investigations. Making presentations to internal/external clients, customers, vendors, and senior management.
- Create, test, and/or improve products by developing complex experiments and tests (including writing and executing protocols), analyze results, make recommendations, and develop reports, based on engineering principles.
- Lead design transfer to manufacturing, provide training to manufacturing operators and colleagues for process, product, and/or equipment.
- Design, build, and execute testing of components or sub-assemblies, document and present test plans to broader audience. The design would include the setting of the requirements as well as critical specifications and functional performance requirements.
- Prepare risk management files (FMEA) and identify mitigations, drive risk management activities from product conception through commercialization.
- Manage Internal and External suppliers’ design, manufacturing, and qualification activities.
- Develop, plan and track risk assessment for device manufacturing non-conformances, change controls, and implement appropriate CAPAs.
- Maintain design control files in accordance with established procedures and current regulatory expectations.
- Project Management experience
- Mechanical Engineering Hands-on experience within Medical Device Industry
- Strong interpersonal skills and the ability to work in a team environment.
- Excellent written and verbal communication skills; excellent technical writing skills of engineering study protocols, reports, SOPs, and other procedures.
- BS in Engineering, Science or equivalent technical degree.
- 5-7 years of experience within the medical device industry.
- Working knowledge of FDA and cGMP regulations and documentation practices.
- 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 equipment design documentation (URS, FS, DS and other engineering specifications), product/process validation (IQ, OQ, PQ, CSV, etc.), Quality Systems (Change Control, Non-Conformances, Requalification, etc.), and Process Excellence Methodologies (Six-Sigma, Lean, etc.).
- Ability to work effectively in a fast-paced multitasking environment.
- Proficient in Microsoft Word, Excel, PowerPoint.
Ideal candidates will exhibit, or have the willingness to develop, the following qualities:
- Strategic thinker with strong analytical skills who can translate client needs into actionable value-added projects/results.
- Ensures activities are efficient, optimized, and client centric.
- Highly motivated and organized, solutions-oriented leader
- Curious and adaptable - has the ability to transform knowledge into actionable activities
- Able to produce results in a fast paced, collaborative environment
Azzur is a GxP compliance and consulting organization dedicated to providing high quality, expertly backed, assistance that drives life science companies to success.
No matter where you are in the product development lifecycle, Azzur is here to help you start, scale, and sustain your business. From pre-clinical manufacturing to process design and process performance qualification, Azzur Group works hand-in-hand with the world's most renowned manufacturers to employ risk-based and phase appropriate GxP solutions.
With a national network of engineers and consultants, we offer comprehensive quality assurance and regulatory and validation services specifically geared for the complexities of life science.
Do What You Love
We are seeking highly motivated individuals that have the desire to learn, are able to adapt to the ever-changing life sciences field and are flexible to work on various projects throughout the Southern California region all while exuding Azzur’s core values: Put Others First, Courage to Take Action, Take Personal Responsibility and Have Fun!
We aim to serve our clients, create a healthy and fun work environment and assist with professional growth for each individual through customized career development plans. As a consultant working on multiple cross functional projects, you will be able to quickly garner a wide range of skills and areas of expertise that will propel your career progression.
If a clear career path forward and a positive, transparent and fun company culture are something you are looking for in your next role, Azzur is the place for you!