Senior Packaging Engineer

Brooksource; New Brighton (MN); On-site; USD 76,000 - 90,000; Full time

Benefits offered by this job

Competitive benefits

401k with company match

Paid time off

Paid holidays

Employee Assistance Program

Job summary

Brooksource in New Brighton, MN is seeking a Senior Packaging Engineer to lead design, development, and validation of packaging for medical devices. You will ensure regulatory compliance across sites, mentor junior engineers, and collaborate with R&D, Regulatory, Quality, and Manufacturing teams.

The role focuses on sterile/non-sterile packaging, transit tests, shelf-life, seal integrity, and ongoing sustainability initiatives.

Qualifications

• Bachelor's degree in Packaging Engineering, Mechanical Engineering, Biomedical Engineering, or related field.
• 5+ years of packaging engineering experience in medical devices, pharma, or life sciences.
• Experience with sterile barrier systems, validation, and regulatory compliance (ISO 11607, FDA QSR, EU MDR).
• Proven ability to lead cross-functional packaging projects from concept through commercialization.

Responsibilities

• Lead design, development, and qualification of sterile and non-sterile packaging for new products and line extensions.
• Serve as technical lead across R&D, Regulatory, Quality, Manufacturing, and Supply Chain.
• Develop and execute packaging validation protocols per ISO 11607, FDA/EU requirements.
• Provide mentorship to junior engineers and cross-site teams.

Skills

Packaging engineering

Sterile packaging

Regulatory compliance

Cross-functional leadership

SolidWorks

Statistical analysis

Education

Bachelor's degree in Packaging Engineering or related

Tools

SolidWorks

Minitab

JMP

Job description

Job Type: 12 month contract to hire on W2 with benefits

Job Pay: 55-65

Job Location: New Brighton, MN (onsite 5 days a week)

We are seeking a Senior Packaging Engineer to lead the design, development, and validation of innovative packaging solutions for our growing portfolio of Class II and III medical devices. This role will serve as a technical expert and strategic partner across various sites, ensuring packaging systems meet global regulatory standards, support operational efficiency, and align with sustainability goals.

Key Responsibilities:

• Lead the design, development, and qualification of sterile and non-sterile packaging systems for new product introductions (NPI), line extensions, and sustaining projects.
• Serve as the technical lead for packaging-related activities across cross-functional teams including R&D, Regulatory, Quality, Manufacturing, and Supply Chain.
• Develop and execute packaging validation protocols (e.g., transit testing, shelf-life, seal integrity) in compliance with ISO 11607, ASTM standards, FDA, and EU MDR requirements.
• Provide technical leadership and mentorship to junior engineers and cross-site packaging teams.
• Collaborate with global manufacturing partners, including international-based operations, to implement packaging solutions and resolve technical challenges.
• Drive cost optimization, risk mitigation, and sustainability initiatives in packaging design and material selection.
• Author and maintain design history files (DHF), specifications, test reports, and other documentation in accordance with design control and quality system requirements.
• Support audits and inspections by providing subject matter expertise on packaging systems and validation processes.
• Stay current with industry trends, emerging materials, and evolving regulatory requirements.

Required Qualifications:

• Bachelor’s degree in Packaging Engineering, Mechanical Engineering, Biomedical Engineering, or related field.
• 5-8+ years of experience in packaging engineering within the medical device, pharmaceutical, or life sciences industry.
• Deep understanding of sterile barrier systems, packaging validation, and regulatory compliance (ISO 11607, FDA QSR, EU MDR).
• Proven experience leading cross-functional packaging projects from concept through commercialization.
• Strong technical writing, documentation, and project management skills.
• Proficiency in CAD software (e.g., SolidWorks), packaging design tools, and statistical analysis (e.g., Minitab, JMP).

Preferred Qualifications:

• Experience supporting international manufacturing sites
• Familiarity with sustainable packaging practices and life cycle analysis.
• Knowledge of UDI labeling, barcoding, and serialization requirements.
• Advanced degree or certifications (e.g., Six Sigma, ISTA, CPP) a plus.

EEO: We are committed to creating an inclusive environment for all employees and applicants. We do not discriminate on the basis of race, color, religion, creed, sex, sexual orientation, gender identity or expression, national origin, ancestry, age, disability, genetic information, marital status, military or veteran status, citizenship, pregnancy (including childbirth, lactation, and related conditions), or any other protected status in accordance with applicable federal, state, and local laws.

Benefits & Perks: Brooksource offers competitive medical, dental, vision, Health Savings Account, Dependent Care FSA, and supplemental coverage with plans that can fit each employee’s needs. We offer a 401k plan that includes a company match and is fully vested after you become eligible, paid time off, sick time, and paid company holidays. We also offer an Employee Assistance Program (EAP) that provides services like virtual counseling, financial services, legal services, life coaching, etc.

Pay Disclaimer: The pay range for this job level is a general guideline only and not a guarantee of compensation or salary. Additional factors considered in extending an offer include (but are not limited to) responsibilities of the job, education, experience, knowledge, skills, and abilities, as well as internal equity, alignment with market data, applicable bargaining agreement (if any), or other law.