Pfizer Device Engineer II in Rocky Mount, North Carolina
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.
How You Will Achieve It
Execute device and manufacturing process changes, including documentation and risk file updates to ensure there is no adverse impact to the patient/user and device design integrity is maintained.
Liaison between GT&E Device Engineering Lifecycle Management (DELCM) and internal production sites, Regulatory, and Quality colleagues.
Execute design change projects with guidance and according to internal procedures, track progress, and communicate status to group leadership.
Establish experimental protocols, conduct experiments, analyze results.
Support technical execution of Design History File (DHF) updates.
Contribute to internal production site Annual Product Record Review activities.
Establish and maintain relationships with internal production site colleagues.
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, with guidance and supervision.
Establish and review specifications / requirements for components, products and processes, with guidance and supervision.
Support CAPA investigations, as appropriate.
Must have a High School Diploma (or Equivalent) and 6 years of relevant experience.
OR an Associate's degree with 4 years of experience.
OR a Bachelor's degree, Engineering, Science or other technical degree, with 0+ years of experience.
Demonstrated knowledge and experience in Device Design Control, Risk Management, Medical Devices, and Combination Products.
Experience analyzing patient/user impact.
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.
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 20%.
Day shift role.
Work Location Assignment:Flexible.
Other job details
Last day to apply: June 6, 2023.
Eligible for employee referral bonus: Yes.
Relocation assistance may be available based on business needs and/or eligibility.
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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.
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