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Job Description
Senior Manufacturing Engineer
Develop and implement manufacturing processes for a medical device company, utilizing cross-functional teams and external manufacturers to drive productivity, quality, and cost-effectiveness.
About the Role
- Collaborate with cross-functional teams and external manufacturers to develop and implement new manufacturing processes.
- Optimize existing manufacturing processes to improve productivity, quality, and cost-effectiveness.
- Design, develop, and implement manufacturing processes, including equipment selection, layout, and validation activities.
- Conduct risk assessments and implement corrective and preventive actions.
- Lead process validation activities, including IQ, OQ, and PQ protocols.
About the Company
The company has developed a breakthrough single-use medical device, Solo+ TTD, addressing pain points in the current treatment of surgical tympanostomy. They have received several awards, including Seedcorn's Overall Winner and Emerging Medtech Company of the Year.
Responsibilities
- Develop and document manufacturing procedures, work instructions, and quality standards to ensure compliance with regulatory requirements.
- Provide technical support and troubleshooting expertise to resolve manufacturing issues.
- Participate in the design transfer process from R&D to manufacturing.
- Collaborate with suppliers to ensure the availability of high-quality components and materials.
- Implement and manage process controls, including statistical process control (SPC) techniques and test method validation.
Requirements
- Bachelor's or Master's degree in Engineering or related field.
- Solid experience in medical device manufacturing, operations, and engineering.
- Strong knowledge of manufacturing processes, including assembly, testing, and packaging.
- Strong experience with quality management systems and regulatory requirements for medical devices.
- Proficiency in process validation, risk management, and statistical analysis techniques.