The Device Engineering Co-Development Director leads a global team that is responsible for support of Pfizer s New Product Introduction (NPI) activities for Medical Device and Combination Products. This position will provide strategic and technical leadership for launch readiness in cooperation with WRD BioTherapeutics, WRD PharmaTherapeutics and GPD Pharmaceutical Sciences in supporting the design transfer and site readiness assessment for all new products and for products transferring sites.
Develop and facilitate a co-development process for Medical Devices and Device Constituent parts of Combination products
Ensure appropriate knowledge management and transfer from R&D to production
Responsible for leading major design changes, including plastic injection molded components of devices
Sphere of control: process qualification and design validation through first year of launch
Shared responsibility between R&D and PGS for DHF / Changes 6 month post launch (R&D partner)
Oversight of DHF content / structure suitable for launch
Co-Lead new technology introduction with R&D
Co-Lead control strategy for production (definition for CQA / CPP)
Support technical audits of new / existing suppliers
Post marketing surveillance plan (PMS Plan) contributor
Responsible for changes that require clinical, human factors, or develop state of the art postmarket
Manage network-wide project prioritization for new product introduction
Coordinate tooling design and engineering Support for the entire lifecycle of custom injection molded components
Coordinate device engineering support for PAI audits at internal production sites and CMOs
Support submission preparation and regulatory strategy for combination product and medical device fillings
Liaison with R&D / Lifecycle Management / Launch Excellence Teams
Bachelor s degree in Packaging, Mechanical, Chemical, Biomedical or related Engineering Science is required. Advanced degree desirable.
15 years experience in Device Design, Quality Engineering, Pharmaceutical Package Engineering, Package Design or equivalent Technical Project Management preferred
10 years experience in Medical Device and Combination Products Design Controls, Production, Sustaining Engineering role or related field preferred
Deep technical expertise in Design Control and Risk Management
Practical application of Design for Reliability and Manufacturing (DRM) and robust device design practices
Practical application of analyzing complex issues for patient/user impact
Experience with FDA investigators and other global regulatory agencies
Thorough understanding and in-depth knowledge of 21 CFR Part 820, ISO 13485 and ISO 14971 and related standards
Deep technical expertise in production and production systems in a GMP regulated environment
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.
Deep technical expertise in device design, development, qualification and registration
Proven project management and complex problem solving skills
Ability to effectively manage and influence global cross functional teams
Excellent relationship management, communication and presentation skills
Excellent verbal, written and interpersonal communication skills
Demonstrated ability to plan, implement, and achieve significant, complex goals and objectives
Demonstrated leadership with proven success in challenging status quo
Strong organizational and planning skills, as well as a high energy level and initiative
Office-based role supporting virtual teams via webex and phone. Flexibility required when working with global colleagues in various time zones.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Must be able to travel up to 30%
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EEO & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.
Last Date to Apply for Job: 8/13/2019
Additional Location Information: Position can be located in any Pfizer Global Site
Eligible for Relocation Package
Eligible for Employee Referral Bonus
N (Other) (United States of America)
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.