Associate Device Engineer

Employer
Pfizer
Location
Rocky Mount, North Carolina, United States
Posted
Oct 16, 2020
Ref
4794621
Required Education
Bachelors Degree
Position Type
Full time

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

ROLE RESPONSIBILITIES

  • Execute device and manufacturing process changes, including documentation and risk file updates to ensure there is no adverse impact to the patient/user and to ensure 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
  • 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 and Complaint investigations, as appropriate

 


BASIC QUALIFICATIONS

 

 

  • Bachelor's degree in Engineering, Science or other technical degree
  • Basic 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

 


PREFERRED QUALIFICATIONS

 

 

 

  • 0-2 years' experience in Medical Device or Combination Products Design Controls, Production, Sustaining Engineering, or Quality role
  • Engineering degrees

 


Other Job Details

Office-based role supporting virtual teams via webex and phone. Flexibility required when working with global colleagues in various time zones.

Must be able to travel up to 20%.

Last date to apply: November 11th 2020

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.

Continuous Imprv and Proj Mgmt