Sr. Associate Device Engineer

Sr. Associate Device Engineer

26 Nov 2024
Kansas, Mcpherson, 67460 Mcpherson USA

Sr. Associate Device Engineer

Vacancy expired!

What Will You AchieveResponsible 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.

How You Will Achieve ItExecute 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 QualificationsBachelor's degree in Engineering, Science or other technical degree.

3+ years' experience in Medical Device or Combination Products Design Controls, Production, Sustaining Engineering, or Quality role.

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.

Preferred QualificationsMaster's degree.

PHYSICAL/MENTAL REQUIREMENTSOffice-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 REQUIREMENTSMust be able to travel up to 20%

OTHER DETAILS:Last day to apply: 12/2021

Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.Sunshine ActPfizer 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 EligibilityPfizer 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.Engineering

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Job Details

  • ID
    JC23517424
  • State
  • City
  • Full-time
  • Salary
    N/A
  • Hiring Company
    Pfizer
  • Date
    2021-11-26
  • Deadline
    2022-01-25
  • Category

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