We are seeking a skilled and detail-oriented Process Engineer with an electrical or mechanical engineering background to join our team.
The successful candidate will be responsible for overseeing the transfer of medical device manufacturing processes from one facility to another, ensuring seamless operation, compliance with regulatory standards, and minimal disruption to production schedules.
Key Responsibilities: Design History File: Ensure that the transferred process adheres to the Device Master Record.
Process Analysis and Documentation: Analyze current manufacturing processes and create detailed documentation to facilitate the transfer of medical devices to new facilities.
Transfer Planning: Develop and implement a comprehensive transfer plan, including timelines, resources, and risk assessments, to ensure a smooth transition between facilities.
Cross-functional Collaboration: Work closely with R&D, Quality Assurance, Regulatory Affairs, and Supply Chain teams to align objectives and address challenges during the transfer process.
Regulatory Compliance: Ensure all transferred processes comply with relevant industry standards, regulatory requirements, and quality assurance protocols.
Equipment and Technology Alignment: Evaluate existing equipment and technologies for compatibility at the receiving facility; recommend upgrades or changes if necessary.
Process Validation: Ensure equipment qualification complies with product requirements.
Training and Support: Provide training and support to facility teams to manage new processes effectively.
Continuous Improvement: Identify opportunities for process optimization and efficiency enhancements before and after transfer.
Reporting and Documentation: Maintain detailed records of transfer activities and provide regular updates to management on progress, risks, and outcomes.
Qualifications: Bachelor's degree in electrical engineering, mechanical engineering, or a related field.
At least 8 years of experience in process engineering, preferably in the medical device industry.
Proven experience in transferring manufacturing processes between facilities.
Strong knowledge of regulatory requirements and quality standards for medical device manufacturing.
Excellent project management and organizational skills.
Ability to work independently and collaboratively in a fast-paced environment.
Strong analytical and problem-solving skills.
Excellent communication and interpersonal skills.
Additional Qualifications: Master's degree in engineering or a related field.
Experience with Lean, Six Sigma, or other process improvement methodologies.
About the Company: The Fountain Group is a nationwide staffing firm with over 80 Fortune 100-500 clients.
Since 2001, TFG has maintained a high standard of excellence, recognized annually through numerous industry awards.
Our success is a team effort.
Learn more about us on our website.
We work in Life Sciences, Clinical, Engineering, IT, and more.
Above all, we specialize in people.
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