Currently seeking a Manufacturing Engineer for a premier leader in the Medical Device industry!

This is an onsite position in the greater Minneapolis region – NOT a remote opportunity. W2 only, No C2C accepted.

We are seeking a detail-oriented and experienced Manufacturing Engineer to support and execute Tech Transfer / Manufacturing Process Transfers within the medical device industry. This role involves overseeing the end-to-end transfer of manufacturing processes from one facility to another, ensuring seamless integration, compliance with regulatory standards, and minimal disruption to production schedules.

****MUST have ability to travel overseas as needed to support process transfer activities.

Key Responsibilities:

Tech Transfer Execution:

• Assist with execution of the transfer of manufacturing processes between facilities, ensuring adherence to timelines and quality standards.
• Collaborate with cross-functional teams, including R&D, Quality, Regulatory, and Operations, to define transfer requirements.

Process Development and Validation:

• Analyze existing manufacturing processes and develop robust transfer protocols.
• Lead process validation activities, including IQ, OQ, and PQ, to ensure compliance with medical device regulations (e.g., FDA, ISO 13485).
• Identify and address gaps in processes to optimize manufacturability and scalability.

Documentation and Compliance:

• Develop and maintain detailed technical documentation, including process maps, work instructions, and risk assessments (e.g., FMEAs).
• Ensure all activities comply with regulatory requirements and company policies.
• Prepare and present reports on transfer progress, challenges, and outcomes to stakeholders.

Training and Support:

• Provide technical training and support to receiving facility teams on new processes and equipment.
• Act as a subject matter expert for transferred processes and address ongoing technical issues.

Continuous Improvement:

• Identify opportunities to enhance manufacturing efficiency, reduce costs, and improve product quality during and after the transfer.
• Implement lean manufacturing and Six Sigma methodologies where applicable.

Qualifications:

Education:

• Bachelor’s degree in Engineering (Mechanical, Industrial, Manufacturing, or related field). Advanced degree preferred.

Experience:

• Minimum 2+ years of experience in manufacturing engineering, with a focus on tech transfer within the medical device industry ideal.
• Hands-on experience with manufacturing process validation and equipment qualification.
• Strong knowledge of medical device regulations (FDA, ISO 13485, cGMP).

Skills and Competencies:

• Exceptional project management skills with the ability to manage multiple priorities and deadlines.
• Proficient in using CAD software, statistical tools, and process simulation tools.
• Strong problem-solving and analytical skills.
• Effective communication and interpersonal skills to collaborate with diverse teams.
• Certification in Lean Six Sigma (preferred).