What are the responsibilities and job description for the Manufacturing Engineer (Medical Device) position at Judge Direct Placement?
We are seeking a highly skilled and innovative Manufacturing Engineer. The ideal candidate will have extensive experience in medical device manufacturing and a proven track record of driving the product development pipeline.
Key Responsibilities:
- Develop, implement, and optimize manufacturing processes for medical devices to ensure high quality and efficiency.
- Be the voice of the customer internally and the voice of the company externally.
- Lead projects to introduce automation and robotics into the manufacturing process to improve productivity and reduce costs.
- Identify and implement cost-saving initiatives without compromising product quality or compliance.
- Collaborate with cross-functional teams, including R&D, quality, and production, to successfully launch new products into manufacturing.
- Conduct process validation and verification activities to ensure compliance with regulatory requirements.
- Analyze production data to identify trends, troubleshoot issues, and implement corrective actions.
- Develop and maintain documentation for manufacturing processes, including work instructions, process flow diagrams, and validation protocols.
- Train and mentor production staff on new processes and equipment.
- Participate in internal and external audits to ensure compliance with industry standards and regulations.
Qualifications:
- Bachelor's degree in Manufacturing Engineering, Mechanical Engineering, or a related field.
- Minimum of 3-5 years of experience in manufacturing engineering within the medical device industry.
- Proven experience with automation and robotics in a manufacturing setting.
- Demonstrated success in leading cost-saving projects and initiatives.
- Experience in launching new products into manufacturing.
- Strong understanding of regulatory requirements and quality standards for medical devices (e.g., ISO 13485, FDA regulations).Excellent problem-solving skills and attention to detail.
- Strong communication and interpersonal skills.
- Ability to work independently and as part of a team in a fast-paced environment.
Salary : $95,000 - $140,000
