Device Engineering Lifecycle Management External Supply Director
: $111,680.00 - $166,760.00 /year *
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The Device Engineering Lifecycle Management External Supply Director is a strategic lead and technical engineering colleague responsible for support of Pfizer s on-market Medical Device and Combination Product design history file lifecycle management and related investigation activities for external supply and contract manufacturing organizations (CMO) globally.
Primary technical interface for CMOs and device platform leads in support for marketed Medical Device and Combination Products (MDCP)
Ensure appropriate knowledge transfer from R&D to CMOs in production
Manage network-wide project prioritization in coordination with Device Engineering Lifecycle management leadership
Proactively manage technical support for suppliers and CMOs in concert with ESQ colleagues
Define and support technical strategy and relationship through collaboration with CMOs and key internal functional stakeholders
Serve as technical leader on the virtual site operations team
Serve as responsible party for Design History File maintenance including any associated processes for review or update
Support technical issue resolution associated with MDCP and delivery system performance, with CMOs, and suppliers
Coordinate tooling design and engineering Support for the entire lifecycle of custom injection molded components
Support day to day design changes, complaints, CAPA, management review
Ensure compliance with all quality technical agreements
Coordinate device engineering support for regulatory body audits at CMOs
Ensure complaint investigations are appropriately concluded, from a design standpoint
Conduct oversight activities / audits as a technical assessor of CMO capabilities and performance
Cultivate strong relationship with CMOs
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
Previous experience at combination product or medical device manufacturing, design, packaging, or testing facility required
Previous experience with cGMPs, GLPs, Complaints, Deviations Investigation, Root Cause analysis, Production and Process Controls, CAPA, and Audits preferred
Practical application of technical audit support preferred
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
Practical 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
Knowledge of regulations and ability to work and develop within complex quality system requirement
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
Molding and Tooling, Device Automation and Assembly, and Testing
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 40%
Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider s name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.
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.