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Manufacturing Engineer II
2 months ago
Primary Talent Partners has a 12 month contract opening for a Manufacturing Engineer II to join a multinational Medical Device company for an onsite position in Billerica, MA.
Pay:
$45.00/hr
Contract : W-2, 12 months, extensions likely, conversion possible
Summary
As a Manufacturing Engineer II, you will play a critical role in ensuring the efficiency and effectiveness of our manufacturing processes, specifically in the context of medical device production. You will be responsible for completing the action phase of Corrective and Preventive Actions (CAPA), overseeing Standard Operating Procedure (SOP) updates, evaluating equipment and fixtures through Installation Qualification (IQ), and driving change control orders. This role requires a meticulous and proactive approach to ensure compliance with industry standards and regulations.
Responsibilities
CAPA Action Phase Completion: Lead and complete the action phase of Corrective and Preventive Actions (CAPA) to address and prevent quality issues.
SOP Updates: Oversee the creation, revision, and implementation of Standard Operating Procedures (SOPs) to ensure they are up-to-date and comply with regulatory requirements.
IQ Evaluation: Conduct Installation Qualification (IQ) evaluations for equipment and fixtures to ensure they meet specified requirements and are fit for use.
IQ Protocol and Report Execution: Develop and execute IQ protocols, and generate comprehensive reports documenting the results.
Change Control Orders: Drive and manage change control orders to ensure all changes to processes, equipment, and procedures are properly documented and implemented.
Continuous Improvement: Identify opportunities for process improvements and implement changes to enhance efficiency, quality, and compliance.
Cross-Functional Collaboration: Work closely with cross-functional teams, including Quality, R&D, and Production, to ensure seamless integration of new equipment and processes.
Qualifications:
Bachelor's degree in Mechanical Engineering, Biomedical Engineering, or a related field is required.
A minimum of 3-4 years of experience in a manufacturing engineering role, preferably within the medical device industry.
Proven experience with Installation Qualification (IQ) processes and documentation.
Experience with computer-aided design (CAD) software.
Experience with catheters is a plus.
Strong understanding of medical device manufacturing processes and regulatory requirements.
Excellent problem-solving skills and attention to detail.
Effective communication and interpersonal skills for cross-functional collaboration.
Ability to manage multiple projects simultaneously and meet deadlines.
Proficiency in using relevant software and tools for data analysis and documentation.
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