Process Engineer Opportunity
We are seeking a skilled and detail-oriented Process Engineer with an electrical or mechanical engineering background to join our organization.
* Job Description: Oversee 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:
o Design History File: Ensure that the transferred process adheres to the Device Master Record.
o Process Analysis and Documentation: Analyze current manufacturing processes and create detailed documentation to facilitate the transfer of medical devices to new facilities.
o Transfer Planning: Develop and implement a comprehensive transfer plan, including timelines, resources, and risk assessments, to ensure a smooth transition between facilities.
o 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.
o Regulatory Compliance: Ensure all transferred processes comply with relevant industry standards, regulatory requirements, and quality assurance protocols.
o Equipment and Technology Alignment: Evaluate existing equipment and technologies for compatibility at the receiving facility; recommend upgrades or changes if necessary.
o Process Validation: Ensure equipment qualification complies with product requirements.
o Training and Support: Provide training and support to facility teams to manage new processes effectively.
o Continuous Improvement: Identify opportunities for process optimization and efficiency enhancements before and after transfer.
o 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.
About This Opportunity:
* Join a nationwide staffing firm with over 80 Fortune 100-500 clients.
* Benefit from a high standard of excellence recognized annually through numerous industry awards.
Additional Qualifications:
* Master's degree in engineering or a related field.
* Experience with Lean, Six Sigma, or other process improvement methodologies.
Keyword: Process Engineer