Principal Packaging Compliance Engineer
Medtronic
Boulder, CO

About $87,000 - $130,000 a year

EducationSkills
Careers that Change Lives

Ideation! Bring quality, compliance packaging knowledge and expertise to the creation and innovation of new products and processes while supporting implementation in multiple manufacturing facilities.
Impact patient outcomes. Come for a job, stay for a career.

We value what makes you unique. Be a part of a company that thinks differently to solve problems, make progress, and deliver meaningful innovations.

Overview and Duties:
Be part of the dynamic team to bring expertise in the areas of quality, regulatory compliance, identification and procurement of new packaging machinery and packaging documentation. Identify, design, develop and evaluate innovative packaging processes as part of a cross functional new product development team. Senior Packaging Compliance Engineer will be frequently assigned leadership responsibility for entire projects including:

  • Lead Remediation activities to bring existing DHF/Tech files to State of the Art compliance and MDR requirements.
  • Perform Gap Analysis of existing documents (Ship Testing, Aging studies, and process validations) to latest standards such as ISO-11607 Part 1 and Part 2.
  • Lead Tech file submission documents and any deficiency support from packaging perspective.
  • Perform Gap Assessment between latest standards (such as ISO, ASTM, ISTA) to last revision.
  • Utilize quality and regulatory compliance expertise to support regulatory body audits, draft technical responses to ensure compliance to latest industry practices.
  • Project Management: Lead project meetings, deliverables and provide updates to management.
  • Provide technical expertise and project support to new product development teams by consulting within areas of packaging materials and equipment.
  • Identifying and supporting the purchasing of new packaging equipment.
  • Preparation of capital expenditure requests, drawings and specifications for new processes and equipment.
  • Assisting in artwork creation and revisions for product packaging.
  • Performing packaging validation testing to support new product development and sustaining.
  • Testing new packaging methods and processes using various testing apparatus in qualification of packaging changes
  • Manage team of engineers to meet business objectives.
A Day in the Life

Responsibilities may include the following and other duties may be assigned.

Designs, develops, and tests a wide variety of containers used for the protection, display, and handling of products.
Determines packaging specifications according to the nature of the product, cost limitations, legal requirements, and the type of protection required, considering need for resistance to such external variables as moisture, corrosive chemicals, temperature variations, light, heat, rough handling, and tampering.
Designs package exteriors considering such factors as product identification, sales appeal, aesthetic quality, printing and production techniques.
Responsibilities may include documentation management and/or coordination of Good Manufacturing Practices (GMPs), and may support prototype line development in manufacturing facilities/plants.
Must Have: Minimum Requirements

Bachelors degree required
Minimum of 7 years of relevant experience, or advanced degree with a minimum of 5 years relevant experience
Nice to Have

  • BS Degree in Packaging Science, Mechanical Engineering or equivalent with minimum of 8-10 years’ combined experience in Packaging and Quality Engineering within Medical devices.
  • Proven track record preparing written policies, procedures, proposals and reports.
  • Knowledge of ISO, ASTM and ISTA package test methods is required.
  • Basic understanding of Medical Device Regulation (MDR) is required.
  • Knowledge of Microsoft Office programs is required.
  • Strong team and interpersonal skills
  • Strong leadership skills with ability to mentor and coach others
  • Broad knowledge of Mechanical/Manufacturing Engineering
  • CAD programming knowledge.
  • Knowledge of TOPS/CAPE
About Medtronic

Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.

We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future.

Physical Job Requirements

The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)