Sr Packaging Engineer - W2 -Medical Device

Grove Technical Resources, INC; North Haven (CT); Hybrid; USD 80,000 - 110,000; Full time

Job summary

An innovative company is seeking a Senior Packaging Engineer for a hybrid role, where you will lead the validation of packaging systems for medical devices. This position offers the opportunity to work on cutting-edge packaging designs, ensuring compliance with industry standards, and driving innovative solutions. You will collaborate cross-functionally, manage projects, and support regulatory audits, making a significant impact in the medical equipment manufacturing industry. If you are passionate about packaging engineering and thrive in a dynamic environment, this role is perfect for you.

Qualifications

• Experience leading validation and gap analysis of packaging systems for medical devices.
• Knowledge of ISO 11607 standards is crucial for compliance.

Responsibilities

• Lead validation of packaging systems for medical devices.
• Conduct gap analysis according to ISO standards.
• Develop remediation plans for packaging.

Skills

Validation of packaging systems

ISO 11607 Part 1 and 2 knowledge

Project management

Communication skills

Cross-functional collaboration

Innovative packaging design

Job description

Sr Packaging Engineer - W2 - Medical Device

Grove Technical Resources, INC is seeking a Senior Packaging Engineer for a hybrid role based in North Haven, CT, or Lafayette, CO, working three days in-office each week.

Key Responsibilities:

1. Lead validation of packaging systems for medical devices.
2. Conduct packaging systems gap analysis according to ISO 11607 Part 1 and 2.
3. Lead project meetings and update management on progress.
4. Evaluate medical device packaging designs and perform gap analysis against industry standards.
5. Develop and execute remediation plans for sterile and non-sterile packaging, including protocol generation, technical documentation updates, and closing reports.
6. Identify innovative packaging processes and determine specifications based on product needs, cost, legal, and protection requirements.
7. Support regulatory audits, draft technical responses, and ensure compliance with industry standards.
8. Perform laboratory testing as per industry standards when required.

Qualifications:

• Experience leading validation and gap analysis of packaging systems for medical devices.
• Knowledge of ISO 11607 Part 1 and 2 standards.
• Strong project management and communication skills.
• Ability to work cross-functionally and innovate in packaging design.

Additional Details:

• Seniority Level: Mid-Senior level
• Employment Type: Contract
• Industry: Medical Equipment Manufacturing