RESPONSIBLITIES
- Develop production schedules and facilitate various production processes.
- Work hands on with the manufacturing operators to achieve daily/weekly manufacturing goals.
- Help coordinate the manufacturing launch of new/existing products.
- Train new operators and supervise to ensure that quality standards are achieved.
- Apply statistical methods to achieve cost reduction, quality improvement, and continuous improvement.
- Support the building of prototypes to demonstrate and test new concepts and product improvements.
- Work to transfer design from product development into manufacturing process.
- Develop test methods and test plans to assure design quality, including bench testing and pre-clinical / clinical study design, implementation, and reporting.
- Work on optimization, Drive understanding for unmet market needs through cross-functional engagement of key stakeholders, including commercial team members and key opinion leaders, and use information to refine product roadmap deliverables.
- Act as liaison for quality activities, such as overseeing lot releases and routine product testing.
- Support other product initiatives, as needed.
EDUCATION AND EXPERIENCE
- Bachelor’s degree in biomedical, mechanical engineering or related field required. Master’s degree preferred.
- 3 years of experience in FDA/GMP and ISO 13485 environment in medical device industry preferred for Engineer-II position.
- Strong technical design capabilities, problem-solving, and organizational skills.
- Solidworks, Autocad, Creo knowledge a plus.
- Statistical analysis knowledge with working knowledge of Minitab and/or Matlab preferred.
- Knowledge of synthetic biomaterials and electrospinning a strong plus.