Specialist, Drug/Device Combo Products (Hybrid)

Job Description

We are seeking a Growth and Improvement minded Engineering Specialist | Device & Packaging Technology that can help drive our Strategic Operating Priorities.

• Invent | Pursue the Most Promising Internal and External Science to Address Significant Unmet Medical Needs

• Execute | Prioritize Resources Behind Our Key Growth Drivers (Oncology, Vaccines, Select Specialty Areas, Animal Health) While Optimizing Our Base Business)

• Adapt | Develop Our People, Culture and Business Model to Evolve with a Dynamic Landscape

• Diverse Talent | We are committed to providing an inclusive and welcoming environment with supporting leadership behaviors because having a high-performing, engaged workforce is critical to our ability to deliver innovative solutions to patients and customers around the world

• Values and Standards | Our Steadfast Commitment to Our Values and Standards will Continue to Guide Us as We Take on New Challenges and Will Always be Fundamental to Our Success – They are a Competitive Advantage for Us

Summary, Focus and Purpose

An Engineering Specialist of Device Development and Technology is a key member of our company's Research Laboratories to our company with responsibilities supporting the commercialization and sustainment of medical devices and combination products globally.

Experience in design controls, device risk management, medical device, combination products, glass/plastic prefilled syringes, pharmaceutical packaging and related scientific/technical concepts and techniques are a must for this position. The ability to apply these in a fast-paced operating environment to resolve issues and meet customer needs in a compliant manner are at the core of this position. The Engineering Specialist will routinely face competing priorities, and must manage time effectively, while keeping stake-holders and team members informed with effective communication.

This individual will be expected to function as an independent contributor, supporting global and site specific projects, including those related to Combination Products and Drug Delivery Systems.  The role includes leading, enabling or consulting in the development and execution of related strategic plans for problem-solving and continuous improvement by working with internal and external partners.

The key stakeholders include our Company Manufacturing Division sites, External manufacturing, R&D, Quality, Operations, Product Development groups, Regulatory Affairs, Procurement and suppliers.

Key Functions

• Work Independently and as a Team member with Integrity | Precision | Accomplishment | Motivational Ambition | Respect | Inclusion

• Complete all activities with the highest regard for all of our Company divisional and local site procedures for safety, quality, and regulatory compliance

• Understand the big picture, and how activities link to our Company strategy and business goals

• Utilize device risk management tools to build device or combination product risk management programs in development and life cycle management

• Utilize design control experience to develop value-add solutions to customer needs in medical devices and combination products

• Secure early sponsorship and stakeholder alignment for projects and initiatives.

• Operate effectively as a leader in assigned roles

• Demonstrate the necessary Inclusion skills to integrate inputs and perspectives from various sources, and communicate the decision to key stakeholders and sponsors

• Solicit feedback to ensure that customer/stakeholder needs are the cornerstone of decisions and expectations

• Lead technical investigations of medical device and combination product needs for commercial products

• Facilitate technology transfer of medical device and combination products from development to commercialization

This job posting covers opportunities within Device Technology Operations under the Technology Transfer and Device Product Stewardship groups supporting commercialization and lifecycle management of combination products. We are actively looking for highly motivated people with a passion for innovation and interest in contributing to one or more of the technical functional areas mentioned above.

Education

• Required | Technical BS degree or higher  

• Preferred | BS in Mechanical Engineering, Chemical Engineering, Biomedical Engineering, Materials Engineering, Pharmaceutical Sciences or similar   

Experience | Skills | Knowledge

Required

• Three ye