Manufacturing Engineer

Job highlights
Identified by Google from the original job post
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
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
Benefits
Pay: $45.00/hr - $55.00/hr based on experience
Responsibilities
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
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
Job description
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 - $55.00/hr based on experience

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.

Primary Talent Partners is an Equal Opportunity / Affirmative Action employer committed to diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, ****** orientation, age, national origin, disability, protected veteran status, gender identity, or any other factor protected by applicable federal, state, or local laws.

If you are a person with a disability needing assistance with the application or at any point in the hiring process, please contact us at info@primarytalentpartners.com

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United States
Massachusetts
Billerica Show on map Get directions