Sr Packaging Development Engineer

The Sr Packaging Development Engineer, performs Disposables Engineering and technical project management responsibilities for the development, commercialization, and life-cycle management of drug delivery devices under minimal supervision. Leverages experience in development of regulated Combination Products. Utilizes solid understanding of theories and practices of a variety of disciplines to manage complex projects or programs within boundaries of quality, time, and budget.

Lead activities to meet business goals by driving quality improvements, meeting delivery requirements, and implementing cost reductions and product enhancements. Requires working in a team environment with cross functional team members, such as manufacturing sites, marketing, quality, regulatory and other departments.

Salary Range: $100,000-$115,000

• Position is eligible to participate in a bonus plan with a target of 6% of the base salary (include only if applicable to the grade level)

• Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities.

• Our benefits and programs are comprehensive and thoughtfully crafted to ensure our colleagues live healthy lives and have support when it matters most. Benefits offered include a 401(k) plan with company contributions, paid vacation, holiday and personal days, employee assistance program, and health benefits to include medical, prescription drug, dental and vision coverage. Read more about our benefits here.

Due to applicable export control laws and regulations, candidates must be a U.S. citizen or national, U.S. permanent resident (i.e., current Green Card holder), or lawfully admitted into the U.S. as a refugee or granted asylum.

Responsibilities

• Leads and provides critical packaging/device development expertise on new product development, particularly for combination products (Pre-filled syringes, pre-mix bags and Auto-injectors) and injectable products in other advanced delivery devices.
• Plans, designs, executes, documents, and analyzes a regimen of tests to evaluate, verify and/or validate a system for systems for Prefilled Syringes, IV Administration Containers, Injection Pens, Autoinjectors and related ancillary devices.
• Evaluates results relative to product requirements, definitions and/or program goals. Applies standard techniques to solving difficult problems.
• Identify causes and mechanisms of system issues identified during testing, and convene design reviews where needed.
• Routinely provide advice and assistance to team members regarding routine and unique problems. May supervise or direct test engineers on assigned projects.
• Translate business needs into product specifications and document in requirements management software
• Leverage SolidWorks CAD experience for the design of drug delivery components.
• Utilize engineering principles, technical analysis, computational analysis, and problem-solving tools to resolve technical problems and quality issues Support Engineering and Packaging Systems Team with designs, fixtures, prototyping and laboratory testing requests.
• Applies DOE principles in packaging development, meeting regulatory and industry requirements.
• This job position within the Business Unit – Pharma of Fresenius Kabi USA hereby commits itself to protect any persons working under its control from work related hazards to health and safety as well as to protect the environment as the basis of life. This includes the prevention of diseases, incidents and pollution as well as the responsible and sustainable use of resources. Our aim is to enhance our performance in the area of occupational and environmental safety, and to fulfill compliance obligations. To achieve this target, we implement and continuously improve the integrated management system according to OHSAS 18001 and ISO 14001.

Requirements

• B.S. degree in Mechanical Engineering with 5 years of relevant experience in plastics or mechanical design.
• Extensive experience in design change and design control procedures.
• Experience in hardware and plastic component design using SolidWorks software.
• Good understanding and application of GD&T
• Familiarity with basic inspection tools, and preferably automated inspection experience
• Must possess a firm foundation in the basic principles of their respective engineering discipline.
• Able to manage own workflow, coordinate resources, and support engineering staff.
• Strong critical thinking skills and the ability to function in a sometimes-ambiguous situations.
• Excellent communication skills, verbal and written.

Additional Information

We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company contribution, and wellness program.

Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.