Senior Engineer, Devices and Combination Product Technology (Hybrid)

Job Description

We are seeking a Growth and Improvement minded Senior Engineer in Device 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

The Senior Engineer is a key member of our Device Development and Technology Organization with responsibilities supporting the commercialization and sustainment of medical devices and combination products globally.

Experience in authoring ISO-13485 and 21 CFR 820 compliance technical documents, design controls, device risk management, medical device, combination products, prefilled syringes, autoinjectors, 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 Senior Engineer 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 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 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.

Education

• Required | Technical BS degree or higher  

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

Required Experience | Skills | Knowledge

• Five years of relevant experience in medical devices or combination products

• Experience in design controls, ISO 13485, deviation management, change control, risk management/ISO 14971-2019 and the fundamentals of documentation structure/systems

• Experience with medical device combination product commercialization, operations support, and materials/components

• Proficiency in GMP documentation, technical writing and project management

• Principled ve