Our Ability Jobs

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.

Qualifications

• 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.

Physical/Mental Requirements

• 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.

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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.

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