Job Title: Senior Manufacturing Process Engineer
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We are seeking an experienced Senior Manufacturing Process Engineer to join our team. The successful candidate will be responsible for developing and implementing manufacturing processes, including equipment selection, layout, and validation activities.
The ideal candidate will have a strong background in manufacturing engineering, with experience in medical device manufacturing. They will be skilled in process validation, risk management, and statistical analysis techniques. Excellent problem-solving skills and the ability to analyze complex manufacturing issues are essential.
In this role, you will collaborate with cross-functional teams to develop and implement new manufacturing processes. You will also be responsible for optimizing existing manufacturing processes to improve productivity, quality, and cost-effectiveness.
To succeed in this position, you will need to have a Bachelor's or Master's degree in Engineering or a related field. A solid understanding of Lean Six Sigma methodologies is desirable. Experience with CAD software and design for manufacturability (DFM) is also a plus.
As a Senior Manufacturing Process Engineer, you will have the opportunity to work on exciting projects and contribute to the growth and success of our organization. If you are a motivated and detail-oriented individual with a passion for manufacturing engineering, we encourage you to apply.
* Main Responsibilities:
* Develop and implement manufacturing processes, including equipment selection, layout, and validation activities.
* Collaborate with cross-functional teams to develop and implement new manufacturing processes.
* Optimize existing manufacturing processes to improve productivity, quality, and cost-effectiveness.
* Conduct risk assessments and implement appropriate corrective and preventive actions.
* Lead process validation activities, including IQ, OQ, and PQ protocols.
* 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.
Qualifications and Skills:
* Bachelor's or Master's degree in Engineering or a 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.
* Excellent problem-solving skills and the ability to analyze complex manufacturing issues.
* Strong communication and interpersonal skills to collaborate effectively with cross-functional teams.
* Detail-oriented with a commitment to maintaining high standards of quality and compliance.