Packaging Engineer II - Exempt

Lancesoft; North Haven (CT); On-site; USD 85,000 - 110,000; Full time

Job summary

Lancesoft in North Haven, CT is seeking an engineer to validate and qualify packaging materials for absorbable suture products, leading projects and coordinating with engineering management.

You will develop validation plans, design containers, ensure GMP compliance, and support prototype line development in manufacturing facilities. A Bachelor's degree in engineering and 3–5 years in medical devices are preferred.

Qualifications

• Experience in equipment IQ, OQ and PQ and/or process validation.
• Understanding of Process Validation Lifecycle from process characterization to performance qualification.
• Preferred experience in DOE with Minitab.
• Experience with CSV, SOP development, and change control of medical devices.

Responsibilities

• Validate and qualify new packaging materials (foil, Tyvek, and film) for absorbable sutures.
• Develop validation plans and processes in compliance with company standards.
• Lead projects and communicate deliverables and timelines to engineering management.
• Design, develop, and test containers for product protection, display, and handling.
• Determine packaging specifications considering cost, regulatory requirements, and protection needs.
• Document management and coordination of GMPs.
• Support prototype line development in manufacturing facilities.

Skills

IQ/OQ/PQ qualification

Process validation lifecycle

DOE with Minitab

CSV validation

SOP development

Change control

Education

Bachelor's degree in Engineering/Mechanical/Manufacturing/Packaging

Tools

Minitab

Job description

Join our dynamic team in North Haven, CT, where you will play a crucial role in validating and qualifying new packaging materials for absorbable suture products. This position offers the opportunity to lead projects and collaborate with engineering management to ensure timely project deliverables.

Key Responsibilities

• Validate and qualify new packaging materials such as foil, Tyvek, and film.
• Develop processes and create validation plans in compliance with company standards.
• Lead projects and communicate deliverables and timelines to engineering management.
• Design, develop, and test a variety of containers for product protection, display, and handling.
• Determine packaging specifications considering cost, legal requirements, and protection needs.
• Document management and coordination of Good Manufacturing Practices (GMPs).
• Support prototype line development in manufacturing facilities.

Must-Have Qualifications

• Experience in equipment IQ, OQ (Operational Qualification), and PQ (Performance Qualification) and/or process validation.
• Understanding of Process Validation Lifecycle from process characterization to performance qualification.
• Preferred experience in Design of Experiments (DOE) with Minitab.
• Experience with computer and software validation (CSV), SOP development, and change control of medical devices.

Nice-to-Have Qualifications

• 1-3 years of experience in the Medical Device industry.
• Familiarity with FDA 21 CFR Part 820, EU 217/745 (EU MDR), and standards such as ISO 13485, ISO 14971, IEC 60601.
• Proficiency in Microsoft Office Applications (Word, Excel, Access, PowerPoint) and Windows OS.
• Strong written and verbal communication skills and ability to work as part of a cross-functional team.

Education and Experience Bachelor's degree (or above) in Engineering, Mechanical, Manufacturing, or Packaging. 3-5 years of relevant experience.

Work Schedule and Location Full-time position, 40 hours per week. Onsite presence required in North Haven, CT.

Be a part of our innovative team and contribute to the success of our GST Focus Factory by validating and qualifying new nylon film for our absorbable suture products.