Associate Director Medical Device and Combination Product Engineer (Hybrid)

Job Description

Position Description: 

Associate Director Medical Device and Combination Product Engineer

The Associate Director in Device Technology is a key member of our Device Development and Technology Organization with responsibilities for supporting the development, commercialization and sustainment of medical devices and combination products globally. 

Experience in design controls, device risk management, medical device, combination products, prefilled syringes, autoinjectors, process validation, automation 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 Associate Director 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 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 

Position Qualifications:

Education Minimum Requirement:

• Required | Technical BS degree or higher   

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

Required Experience and Skills:  

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

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