Manufacturing Engineer I
2 weeks ago
Imperative Care is seeking a highly skilled Manufacturing Engineer I to join our team. This role will be responsible for supporting activities related to equipment used for manufacturing our company products. Key responsibilities include drafting equipment installation/operation qualifications, participating in design studies to determine equipment capabilities, and resolving issues related to calibration, preventive maintenance, and equipment repairs.
As a Manufacturing Engineer I, you will work closely with cross-functional teams to ensure that all manufacturing equipment is installed, qualified, validated, and maintained in compliance with manufacturer specifications and company quality systems and regulatory requirements. You will also be responsible for maintaining current records using technical writing skills and tracking efficiency of current procedures and equipment performance to identify areas of improvement.
Requirements for this role include a Bachelor's degree in engineering or related discipline and less than 2 years of professional experience. Preferred qualifications include exposure to product testing, data collection, or basic knowledge of medical device industry, as well as knowledge or experience working within an FDA or ISO 13485 regulated environment using GDP and GMP practices. Strong analytical and statistical skills using Excel, Minitab, and/or JMP are also highly desirable.
This is an excellent opportunity to join a dynamic team and contribute to the development of innovative medical technologies. If you are a motivated and detail-oriented individual with a passion for engineering, we encourage you to apply for this exciting role.
Key Responsibilities:
- Support activities related to equipment used for manufacturing company products
- Draft equipment installation/operation qualifications
- Participate in design studies to determine equipment capabilities
- Resolve issues related to calibration, preventive maintenance, and equipment repairs
- Maintain current records using technical writing skills
- Track efficiency of current procedures and equipment performance to identify areas of improvement
Required Skills and Qualifications:
- Bachelor's degree in engineering or related discipline
- Less than 2 years of professional experience
- Strong analytical and statistical skills using Excel, Minitab, and/or JMP
- Preferred qualifications include exposure to product testing, data collection, or basic knowledge of medical device industry
- Preferred qualifications include knowledge or experience working within an FDA or ISO 13485 regulated environment using GDP and GMP practices
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