Engineer I, Process Development - Acera Surgical Inc

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.