Manufacturing/Process Engineer

About the job

Design and develop manufacturing processes, tooling, and fixtures in order to meet daily production schedules while enhancing productivity and product quality. Provide manufacturing/sustaining support in production.

Major duties and responsibilities:

• Design and develop manufacturing processes for new products, product changes and enhancements, and related tooling and fixtures which are consistent with a zero-defect level as well as low product cost.
• Create and maintain tool drawings and shop orders in compliance with QA.
• Coordinate and perform IQ/OQ/PQ of processes and equipment.
• Perform validation activities such as process, test method and understanding/use of associated techniques (ie. Gage R&R, statistical methods, etc.)
• Provide support to daily production activities, which may include managing assembler tasks as required for production goals.
• Coordinate work of assigned technicians.
• Plan and schedule projects in a manner consistent with corporate objective.
• Contribute to the intellectual property position of the company via invention and patent applications.
• NCR/CAPA support as it relates to production.
• Support prototype and pilot production of new products, product changes, and enhancements in coordination with the Manufacturing and Quality Control functions.
• Work with product development staff to ensure that products under development are optimally manufacturable and to resolve manufacturing issues.
• Transferring and implementing processes, either from development or from another manufacturing facility.
• GMP compliance in coordination with the Document Control, R&D, and Quality Assurance functions (SOPs, MPIs, LHRs, materials records, etc.)
• Support company goals and objectives, policies and procedures, Good Manufacturing Practices, and FDA regulations (QSR 21 CFR Part 820 and ISO13485).
• Ensure that all regulatory and internal policies are followed.

Education/Experience requirements:

• BS in engineering discipline preferred.
• Minimum 4 years experience.
• Preferred 8-12 years medical device experience (minimum 4-6 years in a manufacturing environment)

Other qualifications:

Working knowledge of engineering terminology and concepts and related software applications (Word, Excel, Project, Solidworks/CAD, Statistical software)

Physical demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to stand, walk and sit for extended periods of time. Occasionally the employee will be required to lift or move at least 50 pounds

To Apply:

Interested candidates should submit their resume to careers@shapemem.com with the job title as the subject.
Resumes from recruiters will not be accepted.