Principal Packaging Engineer – Abbott Laboratories – Lake County, IL, USA
To serve as the primary engineering interface for all the Abbott Diagnostics Division packaging issues, including packaging specification, design, qualification, procurement, and routine support. To work with internal organizations to ensure that Abbott Diagnostics packaging designs conform to all applicable product design, regulatory and market driven requirements. To function as a Subject Matter Expert (SME) for quality audits and suppliers for all packaging related issues.
Major Responsibilities:
Implement and maintain the effectiveness of the quality system.
Primary responsibilities include:
- Define user needs, and procure, characterize, test, and implement new product introduction packaging designs in the Abbott Diagnostics product portfolio to serve the Voice of the Customer (VOC).
- Develop prototype and pre-production consumables required in support of R&D activities, including new or modified reagent kit packaging, consumables for new instrument platforms, and packaging activity tied to new product introduction.
- Create, review and approve quality system documentation associated with new product introduction packaging, including 3-D models, drawings, material specifications, qualification protocols and reports, corrective and preventive actions.
- Maintain and update internal design documents and records related to new product introduction packaging and associated supplier manufacturing processes to meet internal and external customer requirements, and develop lessons learned logs where appropriate.
- Collaborate with Abbott manufacturing sites and other division functions to resolve issues as they arise to ensure new product introduction consumables are designed for manufacturability (DFM) within new and/or existing Abbott Diagnostics production processes.
- Provide technical support, directly or through third party technical resources, for all new product introduction packaging consumables and associated qualification of new Abbott-owned assets and tooling used at supplier sites.
- Complete specific validation and verification activities to ensure design meets intended requirements.
- Participate in risk management activities such as the development of Abbott’s risk management report, Design and Process FMEA’s, control plans and inspection plans to control process variability at the source.
- Interface with paperboard, corrugate, label suppliers and others to ensure reliable supply of required consumables.
- Develop, implement and manage cost reduction efforts for new production introduction packaging activities to meet launch costs and potential post-launch contract agreements.
- Lead environmental initiatives related to packaging reduction or management driven by market or governmental directives.
- May perform other duties as assigned.
Core Job Responsibilities:
Responsible for implementing and maintaining the effectiveness of the quality system.
Collaborates across divisions to develop standards.
Conducts investigates to confirm engineering theories. Analyzes results and applies technical judgment in making substantial adaptations and modifications.
Investigates/recommends novel technology applications.
Develops, evaluates and implements strategic initiatives, leads project/program and technical staff to develop significant new products or processes.
May direct efforts of others.
May coordinate outside resources for projects.
Provides input to the team manager on staffing decisions.
Provides technical mentoring for the discipline.
Routinely provides analyses and advice to senior division management.
Has direct contacts with outside consultants and with technical counterparts from other divisions and key vendors.; Addresses change resistance
Helps individuals overcome resistance to change
Encourages others
Looks for and capitalizes on opportunities to encourage and motivate engineers on ways to adapt to change
Advocates for company
Champions organizational decisions and changes in a credible way; is an open advocate for change
Influences action
Explains value of change using sound rationale; influences peers to accept change; effectively implements change; Project Engineer
Integrates multiples teams
Sets and communicates goals and objectives for overall team; fosters collaboration between multiple teams to accomplish overall goals.
Monitors team performance
Stays close to team performance; helps to keep the team on track; facilitates adjustments when necessary.
Recognizes accomplishments
Looks for opportunities to reinforce, reward, and celebrate the accomplishments of the team.
Uses multiple perspectives
Seeks out and uses multiple perspectives and ideas for accomplishing goals.
Takes action to meet partner needs and concerns
Considers how actions or plans will affect partners; responds quickly to meet partner needs and resolve problems; avoids over-commitments.; Project/Program Engineer
Applies Technology in Innovative Ways
Combines technologies to anticipate or address customer needs; employs proven solutions to increase the effectiveness of engineering methodology or manufacturing process, e.g., incorporates process commonalities to reduce cycle time; attempts to leverage core technical competencies to its limit.
Creates or Advances Technology
Advances recognized leading-edge technologies in a technical field; fosters an environment of innovation in others, e.g., benchmarks current solutions against outside companies. Creates a novel combination of existing or new products or services.; Fosters an environment of integrity
Spends time with employees (including those outside own area) to share experiences, espouse organizational values, and act as a role model through actions.
Models integrity
Acts as a role model for corporate standards of integrity and regularly coaches direct reports on meeting these standards at all time.
; Explores multiple opportunities
Structures studies integrating cross-disciplinary and cross-functional issues to arrive at optimal course of action, e.g., investigates process to meet increasing regulatory requirements while maintaining manufacturing/ construction efficiency.; Defines project scope
Works with marketing, product development , and manufacturing to establish scope, priorities, and schedules on multiple projects, e.g., examines the entire capital planning process for a new product or complex project.
Clarifies and maintains project scope
Clarifies project scope definition for large or multiple projects; monitors and controls implementation plan in accordance with defined scope, e.g., monitors and corrects schedule slippage and financial overruns.; Conceptualizes complete solutions
Creates or coordinates the design solutions for novel or complex problems; integrates regulatory and operational needs; assesses cost benefit, e.g. identifies processes and develops flow charts for a complex construction or manufacturing operation.
Position Accountability / Scope: .
Supervision received is administrative.
Assignments given as broad general objectives and limits.
Establishes the approach and empirical test procedures to be used, and the estimated time, expense and staffing requirements for completion.
Specifies equipment, materials and supplies required for the completion and implementation of technical projects.
Is accountable for success of project and manages all financial aspects of project.
Qualifications
Education:
B.S. in an engineering discipline or equivalent experience
Packaging Engineering degree preferred
Background:
6 – 10 years of experience in a mid-volume manufacturing environment preferred, including some or all of the following:
- Knowledge of applicable regulatory standards and requirements for medical device packaging
- Medical device manufacturing experience preferred
- Creation of drawings, material specifications and packaging testing documents
- Working knowledge of risk management tools, technical data interpretation, basic statistics, quality control and process capability
- Expert understanding of ASTM, ISTA and ISO packaging standards
- Design and procurement of paperboard and corrugate cartons, associated inserts and labels, films and formed packaging
- Cold-chain packaging qualification experience a plus
- Experience with ArtiosCAD, CAPE, TOPS, MS Office, MS Project, Outlook and the product development lifecycle
- Design for Six Sigma (DFSS) or Lean Six Sigma (DMAIC) knowledge a plus
- Effective communication and leadership skills
- Ability to work with cross-functional teams, as team member or team leader
- Self-motivated and driven to achieve results through personal accountability and excellent time management
Significant Work Activities and Conditions
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)
