Responsible for medical device packaging design, qualification, and EU MDR packaging remediation to ensure compliance with industry standards and regulations.

Requirements:

BS in Packaging, Mechanical Engineering, or related field

3–5+ years of experience in medical device or pharmaceutical packaging engineering

Knowledge of medical device package design and qualification

Understanding of ISO 11607-1 and -2 standards

Experience in regulated industries such as medical devices or pharmaceuticals

Background in EU MDR packaging remediation projects

Preferred Skills:

Familiarity with ASTM and ISTA package test methods

Experience supporting regulatory audits and drafting technical responses

Knowledge of sterile barrier systems and non-sterile medical device packaging

Responsibilities:

Evaluate current medical device packaging designs and perform gap analysis against ISO 11607 standards

Develop and execute EU MDR packaging remediation plans, protocols, and reports

Lead validation of medical device packaging systems

Define packaging specifications based on product requirements, cost, regulations, and protection needs

Collaborate with cross-functional teams to develop innovative packaging processes and designs

Update specifications, technical documentation, and labeling in compliance with regulatory requirements

Support regulatory audits with technical expertise and compliance documentation

Lead project meetings and present updates to management

Perform and evaluate laboratory testing of packaging systems per industry standards

Pay Details: $45.00 to $55.00 per hour

Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.

Equal Opportunity Employer/Veterans/Disabled

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The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:
The California Fair Chance ActLos Angeles City Fair Chance OrdinanceLos Angeles County Fair Chance Ordinance for EmployersSan Francisco Fair Chance Ordinance

Massachusetts Candidates Only: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.