Packaging Engineer - Req Exp in Medical Device or Pharmaceutical

MillenniumSoft Inc; Warwick (RI); On-site; USD 41,000 - 55,000; Full time

Job summary

MillenniumSoft Inc. is seeking a Packaging Engineer for a 12-month contract in Warwick, RI. The role focuses on designing, developing, and qualifying packaging systems for sterile and non‑sterile devices, under senior guidance, with emphasis on regulatory compliance.

The engineer will support design controls, document packaging specs, and collaborate with R&D, Quality, Manufacturing, Regulatory, and Supply Chain teams to meet timelines and quality goals.

Qualifications

• Bachelor’s degree in a technical field (Packaging/Mechanical/Biomedical) or related.
• 1–3 years in packaging engineering or related role; regulated industry exposure a plus.
• Basic understanding of medical device packaging concepts (sterile/non-sterile).
• Familiarity with ISO 11607, ISO 13485, packaging ASTM/ISTA standards.
• Foundational data analysis and statistics knowledge; DOE/Six Sigma a plus.
• Experience with CAD/packaging design tools (CAPE, TOPS, SolidWorks) preferred.

Responsibilities

• Support design, development, and qualification of packaging systems for medical devices.
• Assist with design control activities for low to moderate complexity projects.
• Contribute to packaging development projects from concept through verification and transfer.
• Translate product and customer requirements into packaging specs with guidance.
• Collaborate on cross‑functional project teams (R&D, Quality, Manufacturing, Regulatory, Supply Chain).
• Prepare technical documentation: test protocols, reports, work instructions, change controls.

Skills

Packaging engineering

CAD tools

Documentation

Education

Bachelor's degree in Packaging Engineering

Tools

CAD tools

Job description

Position : Packaging Engineer - Req Exp in Medical Device or Pharmaceutical

Location : Warwick, RI

Duration : 12 Months

1st Shift

Total Hours/week : 40.00

pay rate: $30-40/hr

Client : Medical Devices Company

Job Category : Clinical

Employment Type : Contract on W2 (Need US Citizens or GC Holders or GC EAD or OPT or EAD or CPT)

Job Description

Functions and Responsibilities

• Support the design, development, and qualification of packaging systems for sterile and non‑sterile medical devices under the guidance of senior engineers, ensuring compliance with applicable domestic and international standards.
• Assist with the execution of design control activities for low to moderate complexity projects, including development and maintenance of packaging specifications and documentation.
• Participate in packaging development projects from concept through verification and transfer, supporting testing, analysis, and documentation activities to meet defined requirements, timelines, and quality standards.
• Help translate product and customer requirements into packaging and process requirements with mentorship from experienced engineers.
• Contribute as a team member on cross‑functional project teams (R&D, Quality, Manufacturing, Regulatory, Supply Chain), supporting packaging strategy discussions and execution.
• Execute assigned technical tasks with a strong sense of ownership and accountability, escalating risks or issues appropriately.
• Prepare and maintain technical documentation such as test protocols, reports, work instructions, and change control documentation in compliance with quality system requirements.
• Support packaging verification and validation activities, including sample preparation, coordination of testing, data collection, and basic data analysis.
• Apply fundamental engineering principles to solve packaging‑related problems and support continuous improvement initiatives.
• Actively develop technical knowledge in medical device packaging through training, standards review, and on‑the‑job learning.

Required Qualifications

• Bachelor’s degree in Packaging Engineering, Mechanical Engineering, Biomedical Engineering, or a related technical field.
• 1-3 years of experience in packaging engineering, engineering internships/co‑ops, or a related engineering role; medical device, pharmaceutical, or regulated industry exposure is a plus.
• Basic understanding of medical device packaging concepts, including sterile barrier systems and non‑sterile packaging.
• Familiarity with relevant packaging and quality standards such as ISO 11607, ISO 13485, and packaging‑related ASTM or ISTA standards (coursework or practical exposure acceptable).
• Foundational knowledge of engineering statistics and data analysis; exposure to Design of Experiments (DOE) or Six Sigma concepts is a plus.
• Ability to support the development and documentation of packaging requirements and specifications with guidance.
• Familiarity with CAD and packaging design tools (e.g., CAPE, TOPS, SolidWorks, or similar) preferred.
• Strong written and verbal communication skills, with the ability to document technical work clearly and communicate effectively within a team environment.
• Strong organizational skills, attention to detail, and willingness to learn in a regulated, quality‑driven environment.⁰