Sustaining Engineer II

Responsibilities

• Continuous improvement of products, processes and suppliers.
• Lead and execute implementation of sustaining projects following change controls procedures.
• Manage internal and external communication for sustaining projects.
• Perform verification and validation testing as required to implement changes.
• Collaborate with Operations and Product Development to identify supply chain risks.
• Perform root cause analysis investigations of component failures and non-conformances.
• Collaborate with suppliers and internal teams to implement corrective actions.
• Support resolution of customer complaint investigations related to component issues.
• Perform statistical analysis of data and recommend supplier corrective actions based on process monitoring and statistical process controls.
• Collaborate with Quality and Product Development to define component inspection requirements.
• Collaborate with Product Development to recommend improvements to next generation products and processes based on RCA investigations.
• Support supplier development, qualification, and capacity scale up to meet forecasted demand.
• Collaborate with suppliers to create and execute validation plans.
• Recommend suppliers for next generation component development.
• Identify, develop and qualify new suppliers as required to mitigate supply chain risks.
• Create and maintain QMS documentation related to sustaining projects.
• Recommend improvements to SOPs and work processes.
• Work effectively within the confines of a regulated, quality system driven, FDA monitored medical device environment.

Qualifications

• Required minimum education: Bachelor’s degree in engineering or related field
• Required minimum experience: 3 years in a related role
• Medical Device experience preferred
• Experience with root cause analysis
• Experience with process validation (IQ, OQ, PQ) preferred.
• Experience with supplier quality a plus.
• Strong communication and presentation skills.
• A strong desire to lead continuous improvement initiatives.
• Ability to work independently in a fast-paced environment while managing changing priorities.
• A demonstrated desire to work in a small medical device startup.
• A willingness to work hard, with a driven outlook and with a strong desire to succeed as an engineer, as a team, and as a company.