Principal Development Engineer - Device & Combination Products

ROLE SUMMARY 

Device and Combination Product Development (DCP) is a drug/device combination product design and development organization focused on improving patients’ lives through customer-focused innovation and broad-based access to quality medicines and products. 

The DCP Development Engineering team is responsible for the new product development and engineering for a variety of medical device and combination products including sterile injectables, oral dosing devices, topical delivery systems, nasal delivery, and more.  Primary responsibility includes confirmation that product meets it intended function through engineering testing and Design Verification in support of product regulatory submission. 

The Principal Engineer position will also act as the Device Sub-Team lead and will be the Single Point of Accountability (SPA) reporting up through the larger CO-Development Team. The SPA will work with drug product development. Operations, and all functions to support the overall drug and device combination products success.  This role requires strong subject matter command to lead functional development and provide technical guidance, as well as good communication and interpersonal skills to ensure cross-functional alignment. The successful candidate will maintain and leverage a network with internal and external partners and suppliers to establish strong collaborations.  

ROLE RESPONSIBILITIES  

• Partner/lead device team in defining product requirements that are verifiable and will meet the requirements of internal Design Control Procedures 

• Development of sound engineering testing methods, fixtures, and method validation activities to work closely with outside CRO labs or internal Pfizer labs for execution. 

• Project management activities for device and combination product development will include timeline development, resourcing needs, budget development and update reporting to governance groups as needed. 

• Coordinate with internal and external partners and suppliers to procure or manufacture test samples as needed.  Manage conditioning and stability testing for Real Time and Accelerated aging studies. 

• Develop Product Verification Plans including test strategy. 

• Matrix management of device team resources to ensure all functional device activities are completed on schedule following the Pfizer Design Control process. 

• Utilize technical writing and statistical data analysis skills to write protocols and reports. 

• As necessary, conduct root cause analysis and develop recommended solutions based on analysis of data. 

• Execute department initiatives to improve organizational efficiency and business practices. 

BASIC QUALIFICATIONS  

•  BS in Engineering and minimum 10 years of relevant experience (or) MS in Engineering or related Science and minimum 8 years experience (or) PhD in Engineering or related Science and 6 years experience.  

• Experience in new product development for medical device or combination products. Expert working knowledge on Design Controls requirements. 

• Expertise in developing and qualifying sterile injectable container closure systems for combination products. 

• Experience with or leading device and combination product development activities to meet Design Control principles of ISO 134485:2016 or 21 CFR Part 820.30. 

• Experience with ISO standard testing methods and related testing instrumentation for medical device and combination product applications. 

• Experience defining development control strategy utilizing a risk-based approach to define testing requirements and sample sizes. 

• Understanding of regulatory requirements for product verification and validations for the pharmaceutical and medical device industry. 

• Independent problem solving and working with minimal direction. 

• Strong oral and written communication skills. 

• Experience leading colleagues and/or complex projects with high level of accountability. 

• Experience leading initiatives to improve organizational efficiency and securing cross functional alignment. 

PREFERRED QUALIFICATIONS 

• BS/MS in Biomedical, Mechanical, Chemical, or related Engineering. 

• Project Management experience or skills 

• Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.

PHYSICAL/MENTAL REQUIREMENTS

• Ability to perform mathematical calculations and ability to perform comp