What are the responsibilities and job description for the Manufacturing Engineer position at Planet Pharma?
**Job Title:** Manufacturing Engineer
This is an onsite role in North Haven, CT. Only candidates local to the area or willing to relocate should apply.
About the Role
We are seeking an experienced Manufacturing Engineer to validate and qualify new packaging materials for absorbable suture products. This role will also assist with process development activities and creating validation plans in compliance with company standards.
Key Responsibilities:
- Design manufacturing processes, procedures, and production layouts for assemblies, equipment installation, processing, machining, and material handling.
- Optimize machine arrangement within plant facilities for efficient and productive layout.
- Develop sequence of operations and specify procedures for tool and equipment fabrication.
- Adapt machine design to factory and production conditions.
- Incorporate inspection and test requirements into the production plan.
- Inspect machinery, equipment, and tools for efficiency and investigate corrective action for problems and deficiencies.
- Develop manufacturing processes applicable to statistical process control.
- Provide guidance on design concepts and specification requirements to best utilize equipment and manufacturing techniques.
- E nsure processes and procedures comply with regulations.
Requirements:
Bachelor's Degree with 2-5 years of experience.
Nice to Have:
- Design and development of a packaging system for terminally sterilized medical devices as per ISO 11607-1 standards.
- Validation of processes for packaging medical devices that are terminally sterilized as per ISO 11607-2 standards.
- Strong working knowledge of FDA Medical Devices Part 820 Quality System (QS) Regulation & Medical Device Good Manufacturing Practices.
Top Skills Needed:
- Packaging Experience.
- Validation Experience – Process Development, OQ, IQ, PQ.
- Familiarity with Cognex and Keyence based vision inspection systems.
