10 days old

Principal Device Engineer MDCP

Pfizer
McPherson, KS 67460
**Why Patients Need You**



Whether you are involved in the design and development of a product or manufacturing processes for products or supporting investigations and reliability, engineering is vital to making sure customers and patients have the medicines they need, when they need them. Working with our innovative global technology & engineering devices team, you'll help bring medicines to the world even faster by imagining what's possible and taking action.



**What You Will Achieve**



You be responsible for technical leadership of device and combination product lifecycle management at McPherson manufacturing site. This role is site facing to establish technical Medical Device and Combination Product (MDCP) programs and sustain on-market MDCP products through change and risk management. . Your engineering skills will help in recommending and implementing improvements, modifications or additions that will help in solving problems. You will review product requirements in terms of product development compatibility and help Pfizer determine optimum approaches for product and process improvements.



It is your hard work and focus that will make Pfizer ready to achieve new milestones and help patients across the globe.



**How You Will Achieve It**



+ Provide technical support for medical device and combination product processes in manufacturing.

+ Maintain compliance of on-market product with Design History file (DHF) and Technical Files

+ Support of process and device improvements projects as needed.

+ Coordinate technical support for MDCP remediation initiatives including planning and executing studies; writing technical reports summarizing results; and generating / organizing necessary data to support product impact assessments.

+ Facilitate, support, and/or execute verification of device components/system, including risk assessments, risk mitigation strategies and risk plans

+ Develop technical impact assessments for change requests related to device design; develop execution plan and support manufacturing, engineering and validation to implement those changes

+ Support investigations of customer complaints or manufacturing related investigations to determine root cause and implement appropriate corrective and preventive actions

+ Partner with site technical support team for investigation resolution, equipment and process validation activities, test method validation, training on new device related process technologies and on significant changes to related manufacturing procedures

+ Identify and lead process/product/device improvement opportunities and/or corrective actions to increase yield, maximize capacity, improve quality, reduce costs and decrease process variability while maintaining regulatory compliance.

+ Participate in start-up efforts of new equipment, software or processes or commercialization of new products, serving as a technical device SME for process-related issues at the facility

+ Collaborates with other technical support groups to implement process technology initiatives, including scoping new capital investments

+ Support establishment of trending/monitoring of critical quality attributes/critical process parameters to maintain product quality and to control process variance

+ Ensure preparedness to represent the DHF / Technical Files during regulatory authority or 3rd party inspections

+ Partner with manufacturing to meet the production schedules, ensure commercial supply, uphold quality standards,driving towards zero defects

+ Actively share knowledge with others within the team through existing knowledge sharing processes and systems.

+ Apply technical knowledge of Operations, Quality, Validation, etc. along with internal/external business challenges to provide input into recommendations for improvements.

+ Lead multi-functional project teams through high technical risk assessments and complex engineering/technology solution development.



**Qualifications**



**Must-Have**



+ Bachelor's Degree in Mechanical, Biomedical, Chemical, or Manufacturing Engineer or related science

+ 5+ years of demonstrated experience in product development, manufacturing science and technology, sterilization or process validation or Process Engineering within the pharmaceutical industry

+ Thorough knowledge of cGMP (current Good Manufacturing Practices), combination device regulations, design control

+ Strong history of problem solving skills, project and task management skills, ability to manage priorities and lead others under pressure

+ Strong verbal and written presentation communication skills and attention to detail



**Nice-to-Have**



+ Master's degree

+ Relevant pharmaceutical experience

+ 5+ years of experience in a medical device or combination product manufacturing facility



**OTHER DETAILS**



+ **Eligible for Relocation Package** : YES



**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 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.



Engineering



\#LI-PFE

Categories

Posted: 2022-05-09 Expires: 2022-06-08

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Principal Device Engineer MDCP

Pfizer
McPherson, KS 67460

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