We are seeking a Reliability Engineer to perform hazard evaluation, failure analysis and develop risk mitigation strategies in a regulated, biotech environment.  The position will work closely with R&D, manufacturing, process, packaging and quality to provide guidance on the reliability of new product designs that will ensure sustained robustness.  The position will also lead the effort to design relevant experiments, collect/analyze data and make sound recommendations to achieve high reliability as the company grows and scales up.    

• Actively participate in engineering design reviews and define appropriate metrics to measure/evaluate product reliability
• Develop/conduct Design of Experiments (DOE) and reliability studies that would lead to  understanding of multiple variables that may affect product performance    
• Define/establish test methods and statistical process control procedures to achieve desired product reliability
• Propose/recommend appropriate materials, components and engineering concepts that minimize or eliminate the risk of failure 
• Determine statistical sample size required for technical reliability studies 
• Evaluate the current manufacturing hardware/software/process and make recommendations for achieving high reliability as the company scales and gears up for increased production throughput 
• Work with internal engineering team as well as outside service providers to qualify new components, equipment and  processes from reliability standpoint
• Using statistical software tools such as Minitab, perform data analysis, prepare relevant presentations/documentations/reports, highlight reliability issues and make appropriate recommendations 
• Create appropriate infrastructure and set high standards for achieving/maintaining quality and reliability      
• Review design changes for their impact on Quality and Reliability 
• Participate and actively contribute to continuous improvement efforts that will streamline and improve the reliability process
• Comply with company’s policies and guidelines regarding design control, validation activities and documentation

Qualifications

• BS degree in physics or mechanical Engineering or related technical field
• 5-7 years of relevant engineering reliability experience in complex medical technologies
• Must be hands-on and  be able to independently develop and perform experiments 
• Extensive experience with mechanical/environmental stress, shock, drop, vibration and accelerated testing
• Proven track record in a regulated environment , ISO, cGMP and QMS standards
• Proficient with applying DOE, statistical analysis tools such as Minitab, dFMEA, pFMEA and other techniques to identify failure modes at system, sub-system and component level
• Excellent verbal, written, presentation and interpersonal skills
• Strong analytical and problem-solving skills 
• Creative, self-motivated and flexible to work in a small company environment and assume a wide variety of tasks

Preferred Qualifications

• MS or PhD in physics, engineering or equivalent
• Knowledge/experience with polymers and processes such as injection molding and pressure forming
• Familiarity with sterilization process

Travel

Up to 10%

PM20