Offer summary

Qualifications:

Bachelor’s degree in Packaging Engineering, Mechanical Engineering, Biomedical Engineering, or a related field., 7–10+ years of experience in packaging engineering within a regulated industry, preferably medical devices., Deep knowledge of regulatory standards such as ISO 11607, ISO 14971, and 21 CFR Part 820., Strong project management and communication skills, with the ability to work independently..

Key responsabilities:

Lead the design, development, and validation of packaging systems for sterile medical devices.

Collaborate with cross-functional teams to support product development and market launches.

Author and review packaging development documentation including protocols and risk assessments.

Ensure compliance with global regulatory standards and manage multiple priorities across projects.

Job description

Description

About Adept Group

Adept Group offers an award-winning workplace for exceptional packaging industry talent. We work on a range of innovative projects for iconic brand owners. Our technically gifted team collaborates to produce unparalleled results.

We offer a great place to showcase your expertise and build upon your skillset. All while having fun with amazing people from a variety of diverse backgrounds. We’re driven, inspirational and most importantly, human.

We offer a flexible, creative culture focusing on 3 pillars - our environment, our communities, and our health and well-being. Join a team committed to building a sustainable future!

The Opportunity

Adept Group is seeking an experienced Senior or Principal Packaging Engineer (1099 Contract) to lead packaging development and validation efforts for medical device projects. This is a part-time 20-hours per week, contract (1099) opportunity, ideal for an expert-level contributor who thrives in regulated environments and enjoys working independently and cross-functionally on complex packaging challenges.

The ideal candidate will bring deep expertise in sterile packaging systems, a solid understanding of global regulatory requirements (ISO 11607, ISO 14971, CFR 820, EU MDR), and hands-on experience in both product development and packaging process validation (IQ/OQ/PQ).

Exceptional communication and project management skills are essential in this highly collaborative, remote-based role.

Key Responsibilities:

Lead the design, development, and validation of packaging systems for sterile medical devices.
Collaborate with cross-functional teams including R&D, Regulatory, Quality, and Manufacturing to support product development and market launches.
Author and review packaging development documentation including protocols, reports, specifications, and risk assessments.
Ensure compliance with global regulatory standards, including ISO 11607, 21 CFR Part 820, ISO 14971, and EU MDR.
Drive and support risk assessments, DFMEA/PFMEA activities, and design reviews for packaging.
Develop and execute validation strategies for packaging processes using IQ/OQ/PQ methodology.
Provide subject matter expertise on sterile barrier materials and configurations including Tyvek®, pouches, header bags, FFS blisters, preformed thermoformed trays, shelf cartons, labels, and shipping containers.
Act as a technical lead for packaging-related inquiries during audits or regulatory submissions.
Manage multiple priorities and timelines across projects with minimal supervision.

Required Qualifications:

Bachelor’s degree in Packaging Engineering, Mechanical Engineering, Biomedical Engineering, or a related field.
7–10+ years of experience in packaging engineering within a regulated industry, preferably medical devices.
Deep knowledge of applicable regulatory and industry standards:
- ISO 11607
- ISO 14971
- 21 CFR Part 820
- EU MDR
Working knowledge of test methods for packaging integrity and stability (e.g., ASTM, ISTA standards).
Demonstrated experience in sterile packaging development and validation.
Proficient in risk management, specification development, and process validation (IQ/OQ/PQ).
Strong project management and organizational skills.
Excellent verbal and written communication skills.
Ability to work independently in a remote, fast-paced environment.

Preferred Qualifications:

Advanced degree (MS) in Packaging or Engineering discipline.
Experience supporting regulatory submissions (FDA, EU).

Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.

Required profile