Manufacturing Engineer II - Packaging

IntePros; North Haven (CT); On-site; USD 70,000 - 100,000; Full time

Job summary

An established industry player is seeking a Manufacturing Engineer II to lead the validation and qualification of new packaging materials for absorbable suture products. This role involves process development, creating validation plans, and ensuring compliance with company standards. The ideal candidate will have a strong background in packaging and validation, with the ability to design efficient manufacturing processes and layouts. Join a forward-thinking company that values innovation and quality, and make a significant impact on the production of medical devices.

Qualifications

• Requires a BS in Engineering with 3-5 years of relevant experience.
• Practical knowledge in packaging and validation processes.

Responsibilities

• Validate and qualify new packaging materials for suture products.
• Design manufacturing processes and production layouts.
• Ensure compliance with regulations and quality standards.

Skills

Packaging Experience

Validation Experience

Process Development

Familiarity with Cognex

Familiarity with Keyence

Education

BS in Engineering

Mechanical Engineering

Manufacturing Engineering

Packaging Engineering

Job description

Job Title: Manufacturing Engineer II

Location: North Haven, CT

Employment Type: Full-time

Seniority Level: Mid-Senior level

Job Description:
The ME will be responsible for validating and qualifying new packaging materials (foil, Tyvek, film) for absorbable suture products. The ME will be responsible for process development activities and creating the validation plans in compliance with company standards. The ME will be the project lead and communicate project deliverables and timing to engineering management.

Top 3 Technical Skills Required:

1. Packaging Experience
2. Validation Experience – Process Development, OQ, IQ, PQ
3. Familiarity with Cognex and Keyence based vision inspection systems

Education Required: BS (or above) Engineering Degree; Mechanical, Manufacturing, Packaging

Years of Experience Required: 3-5

Responsibilities:
Responsibilities may include the following and other duties may be assigned:

1. Validating and qualifying new nylon film for absorbable suture products.
2. Designing manufacturing processes, procedures, and production layouts for assemblies, equipment installation, processing, machining, and material handling.
3. Designing the arrangement of machines within plant facilities to ensure the most efficient and productive layout.
4. Designing the sequence of operations and specifying procedures for the fabrication of tools and equipment and other functions that affect product performance.
5. Adapting machine or equipment design to factory and production conditions.
6. Incorporating inspection and test requirements into the production plan.
7. Inspecting the performance of machinery, equipment, and tools to verify their efficiency, and investigating and initiating corrective action of problems and deficiencies to ensure product quality.
8. Developing manufacturing processes that are applicable to statistical process control.
9. Providing guidance to engineering regarding design concepts and specification requirements to best utilize equipment and manufacturing techniques.
10. Ensuring processes and procedures are following regulations.

Nice To Have:

1. Design and development of a packaging system for terminally sterilized medical devices as per requirements established by ISO 11607-1.
2. Validation of processes for packaging medical devices that are terminally sterilized as per requirements established by ISO 11607-2.
3. Strong working knowledge of FDA Medical Devices Part 820 Quality System Regulation & Medical Device Good Manufacturing Practices.

Required Knowledge and Experience:
Requires practical knowledge and demonstrated competence within the job area typically obtained through advanced education combined with experience. Requires a University Degree and minimum of 2 years of relevant experience, or advanced degree with 0 years of experience.