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.
Requirements
- 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 within medical device, pharma, or biotech industry
- 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