Principal Systems Engineer, Device And Combination Product

Pfizer Lake Forest , CA 92630

Posted 3 months ago

Hospira, a Pfizer company, is the global leader of injectables drugs and infusion technologies, committed to putting patients first by improving access and care worldwide.

THE ROLE:

Differentiated Drug Delivery (DDD) is a drug device combination design and development organization focused on improving patients' lives through customer-focused innovation and broad-based access to quality medicines and products. Supporting the Pfizer Essential Health business unit (formerly Pfizer's Global Established Pharmaceutical (GEP) organization) specifically the sterile injectables products, the Systems Engineering function has the primary responsibility for developing Design History File (DHF) documentation for ensuring compliance to CFR 820.30 Design Controls and risk management per ISO 14971 for the device constituent and drug-device interfaces of combination products. The Systems Engineering team owns deliverables that document safety and efficacy for new product submissions and also provide for post-market risk assessment and change control. The Systems Engineering function has primary responsibility for developing Design History File (DHF) documentation for ensuring compliance to CFR 820.30 Design Controls and risk management per ISO 14971 for the device constituent and drug-device interfaces of combination products. The Systems Engineering team owns deliverables that document safety and efficacy for new product submissions and also post-market maintenance activities such as risk assessment, change management, and technical support for regulatory inquiries.

This position is responsible for end-to-end product life cycle management including creating and maintaining product requirements and risk files, establishing and publishing traceability, and providing for on-market support and maintenance for newly launched products. In compliance with CFR 820 and corporate procedures, this position will be responsible for documentation generated in support of product development and submissions.

ROLE SUMMARY

Device and Combination Product (DCP) is a drug device combination design and development organization focused on improving patients' lives through customer-focused innovation and broad-based access to quality medicines and products. Supporting the Pfizer Hospital business unit primarily sterile injectables products, the Systems Engineering function has the primary responsibility for developing Design History File (DHF) documentation for ensuring compliance to CFR 820.30 Design Controls and risk management per ISO 14971 for the device constituent and drug-device interfaces of combination products. The Systems Engineering team owns deliverables that document safety and efficacy for new product submissions and also provide for post-market risk assessment and change control.

The Principal Systems Engineer is responsible for all aspects of systems engineering including project planning, creating and maintaining user/product requirements and risk files, mentoring junior engineers, establishing and publishing the traceability between all aspects of product definition and risk management for assigned differentiated drug delivery (drug device combination) products. S/he will work collaboratively with a cross-functional team with an emphasis on delivering a set of requirements that will drive design outputs, Human Factors activities, as well as the acceptance criteria for Design Verification and Design Validation, and ultimately the DHF elements that are transferred to manufacturing.

  • Determines the DHF Structure and owns the Requirements and Risk Management File. Primary responsibility for DHF content for compliance to governing procedures and CFR 820.30 including management of complex product configurations and platforms.

  • Interfaces with commercial and medical colleagues to drive clarity and documentation for product user needs, use environment, and system actors within the product life cycle.

  • Partners with other functions in the organization to ensure stakeholders' requirements are addressed and met as appropriate; to provide consistent direction to cross functional teams and mentorship/guidance to junior engineers in new product development.

  • Responsible for independently leading and researching product requirements including alignment to consensus standards, relevant agency guidance, and Design Verification methodology to ensure testable and consistent product definition.

  • Responsible for medical device risk management per ISO 14971, including the analysis of interactions and risk assessment of drug-device interfaces. Develops a comprehensive assessment and report of Use, Design, and Process risk and mitigation to create the Risk Management Report.

  • Provides evidence of DHF completeness and alignment through management of traceability utilizing industry best practices and technology.

  • Supports the generation of regulatory submission documentation and as necessary support internal and external audits. Ensures high quality deliverables in compliance with regulation and local procedures.

  • Provides leadership to the Systems team in developing advanced concepts, techniques, and standards. Maintains current knowledge of industry best practices and technological trends.

  • Participates in cross-functional team and represents as functional leader to continuous improvement initiatives to establish processes and solve complex problems.

  • Works within multi-disciplinary teams within DCP. Interfaces with core teams within DCP, Regulatory and QA groups, Pfizer Global Supply (PGS), Pfizer Commercial, Pfizer clinical groups and other groups within Pfizer involved in device development.

BASIC QUALIFICATIONS

  • Bachelors of Science in Engineering (Chemical Engineering, Biomedical Engineering, Mechanical Engineering) or science discipline and 7+ years of experience; or Masters of Science and 4-8 years of experience; or PhD and minimum of 3 years of experience.

PREFERRED QUALIFICATIONS

  • Medical device industry preferred; other regulated industries such as aerospace may be considered.

  • Understanding of FDA and EU regulations. Expert working knowledge of CFR 820.30 Design Controls and ISO 14971.

  • Previous experience in combination products risk management.


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.

Other Job Details:

  • Eligible for Employee Referral Bonus

N (Other) (United States of America)

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.


icon no score

See how you match
to the job

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon
lc_ad

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Sr Associate Regulatory Affairs Combination Products

Pfizer

Posted 3 months ago

VIEW JOBS 9/7/2019 12:00:00 AM 2019-12-06T00:00 ROLE SUMMARY * Provides regulatory affairs support by preparing labeling and supplements for FDA drug dossiers for new product presentations or lifecycle changes. * May be part of a DHF remediation project team. * Will be a team member for some project teams; once proficient will take the lead role. Will have a mentor/manager for support. ROLE RESPONSIBILITIES * Provides regulatory advice and support to assigned products/teams. * Identifies and communicates regulatory needs and strategies, considering both drug and device regulations. * Maintains awareness of applicable regulations. * Prepares pharmaceutical submission supplements that meet FDA regulatory requirements and guidelines. * Represents Regulatory Affairs at meetings and presents agreed upon regulatory positions. PROBLEM SOLVING: * Reviews critical documents and determines applicability and acceptability for regulatory submission, seeking guidance when necessary. * Understands the content of the submission information and is able to ensure consistency within and between dossiers as appropriate. * Able to follow scientific arguments and ensure data is complete and sound. * Works independently with other functional areas to obtain all information required for change requests and submissions. Interprets regulations and assure regulatory compliance. * Exercises good judgment within policy and regulations. Must be able to easily deal with complexity, uncertainty, and large bodies of work. ACCOUNTABILITY: · Responsible for tracking and completion of assigned activities for a broad portfolio of molecules and devices. Accountable for accuracy of work and meeting multiple, simultaneous deadlines. Missed registration deadlines or inaccurate registration packages can result in missed sales or regulatory action letters. Follows scientific arguments, identifies regulatory scientific data needs and with supervision solves regulatory issues. · Presents scientific data effectively orally and in writing in a logical and persuasive manner. AUTHORITY TO ACT: · Independently prepares regulatory documentation for submission to FDA. Acts independently on all routine issues, makes judgments and executes. QUALIFICATIONS * Bachelors degree in pharmacy, nursing, biology, chemistry, pharmacology, engineering or a related subject; is required. A Masters degree is preferred. A Ph.D. is highly preferred. * 3-5 years of experience in regulatory affairs, research, development or related area with experience working with RA. PHYSICAL/MENTAL REQUIREMENTS Critical thinking skills, excellent writing skills, strong scientific skills, good interpersonal communication skills are required. Ability to adroitly adapt to constantly changing expectations and want to and be able to learn very quickly, then apply those learnings to project programs. Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact. 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. Other Information * Eligible for Employee Referral Bonus #LI-PFE N (Other) (United States of America) Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates. Pfizer Lake Forest CA

Principal Systems Engineer, Device And Combination Product

Pfizer