Principal Device Engineer

Why Patients Need You
Whether you are involved in the design and development of manufacturing processes for products or supporting maintenance and reliability, engineering is vital to making sure customers and patients have the medicines they need, when they need them. Working with our innovative engineering team, you will help bring medicines to the world even faster by imagining what's possible and taking action.
What You Will Achieve

• Responsible for device lifecycle management of on-market medical devices and combination products
• Develop change management technical impact assessments, design and development plans, risk management and design verification plans, test methods and data analysis.
• Ensure the design controls are documented in accordance with internal procedures.

Role Responsibilities

• Lead design changes, process changes and risk management updates. Track progress and communicate status to management
• Guide, motivate and/or oversee the activities of individuals and teams with focus on project/program issues
• Liaison between GTEL Device Engineering and external production sites, Regulatory, and Quality colleagues
• Plan and execute technical strategy, protocols, tests and reports for line extensions and market expansion activities with production sites and Regulatory Affairs
• Establish and review specifications / requirements for components, products and processes
• Identify Design History File (DHF) enhancements / updates for specific device presentation / platform
• Assess trends in post-market surveillance and production controls to identify and execute continuous improvement activities for device presentation / platform and processes
• Support investigations of delivery system customer complaints to determine root cause and implement appropriate corrective and preventive actions
• Support Manufacturing and Quality Assurance in the disposition of Non-Conforming Reports and the qualification of material / processes / changes to assure reliability requirements are met
• Identify, communicate, and develop mitigation strategies for technical risks with key stakeholders per appropriate escalation thresholding
• Contributor to Annual Product Record Review
• Represent device engineering on change / CAPA review board, as needed

Basic Qualifications

• Applicant must have a High School Diploma (or Equivalent) with 10+ years of relevant experience;
• OR an Associate's degree with eight years of experience;
• OR a Bachelor's degree with at least 5+ years of experience;
• OR a Master's degree with more than three years of experience;
• OR a Ph.D. with 0+ years of experience.
• Prior experience in Medical Device or Combination Products Design Controls, Production, Sustaining Engineering, or Quality.
• Strong knowledge and experience in Device Design Control, Risk Management, Medical Devices, and Combination Products.
• Experience analyzing patient/user impact.
• Experience in a GMP regulated industry.
• Understanding and practical knowledge of 21 CFR Part 820, ISO 13485 and ISO 14971 and related standards.
• Critical thinking, and problem-solving skills.
• An ability to work independently as well as a member of a team in a fast-paced environment.
• Working knowledge of statistical methods for data analysis
• Experience with Computer Aided Design (CAD) software.

PHYSICAL/MENTAL REQUIREMENTS

• Hybrid 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 20%.
Work Location Assignment: Hybrid
Last Date To Apply: January 29, 2025
The annual base salary for this position ranges from $96,300.00 to $160,500.00. In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 12.5% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life's moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site - U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.
Relocation assistance may be available based on business needs and/or eligibility.
Sunshine Act
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. This position requires permanent work authorization in the United States.
Engineering
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