Principal Systems Engineer, Device Combination Products

ROLE SUMMARY

The Principal Systems Engineer is part of the Systems and Risk Management Team supporting the Pfizer Hospital Business Unit. The engineer will utilize their engineering/technical skills and knowledge to assist in the development of Design History File (DHF) to ensure compliance to CFR 820.30 Design Controls and Risk Management for the device constituent and drug-device interfaces of combination products. The engineer will collaborate with other functional teams on researching requirements and owning DHF risk management deliverables to ensure the safety and efficacy for new product submissions.

ROLE RESPONSIBILITIES

As a Principal Systems Engineer, you will utilize your engineering and research skills to create, manage, analyze, and maintain the DHF, product risk management files (risk planning, risk analysis, risk mitigation, and verification of risk control implementation/effectiveness), and associated documents. In compliance with governing procedures, 21CFR 820.30 Design Control, CFR Part 4 Combination Products, and ISO 14971 , you will help support product development and submission activities. Specifically, the Principal Systems Engineer will:

• Provide technical support in the development of the Design History File for Combination Products including global regulatory filings, DHFs, risk management, and design controls
• Research device clinical use, standards, and other relevant regulatory guidance for DHF content generation in support of regulatory submissions with compliance to governing procedures, 21CFR 820.30 Design Control, CFR Part 4 Combination Products, and Risk Management per ISO 14971 for the device constituent and drug-device interfaces of combination products.
• Research industry best practices and define state-of-the-art
• Analyze comparable product complaints historyand standards for product requirements to create robust design requirements ensuring user needs are met
• Partner with other functions including manufacturing, Safety/Clinical, Human Factors andDesign Engineeringto develop FMEAs ensuring root causes and errors are identified & mitigated; provide support to risk management activities; provide risk and systems engineering input to cross functional teams and to instill a spirit of collaboration throughout the organization.
• Supports Combination Product inspection readiness and regulatory responses as needed.
• Participate in focus groups in early use case development to identify unmet needs for design & engineering concept development.
• Support the completion of gap assessments against industry regulations or standards
• Extract and summarize scientific information from internal studies to identify details required for regulatory submissions, regulatory responses, inspection readiness.
• Author technically simple and complex documentation to ensure technical competence to relevant local and federal regulations by working closely with various departments including Systems, Risk Management, Safety, Clinical, Human Factors, and Design Engineering.
• Provide SME level support including training and coaching of employees on risk management and design control across the organization and greater Pfizer
• Recommends, creates, and revises standard operating procedures to support changes in FDA regulations, standards, Medical Device Reporting (MDR), and EU MDR
• Deep knowledge of best practices utilized in the industry related to systems and risk management.
• Implements improvements in the design control/risk management process to reduce speed to market
• Serves as a representative on standards committees.
• Thorough understanding of design controls/risk management from concept through post-market

BASIC QUALIFICATIONS

• Bachelor's Degree with 7+ years of industry experience or Master's Degree with 5+ years of industry experience with a degree in engineering, physical sciences, or technical writing
• Basic understanding of engineering principles, system design, and risk management
• Experienced with performing risk assessments using a variety of tools (e.g. FMEA, FTA, HACCP, etc.)
• Broad technical knowledge related to the design/operation of drug combination product platforms, design control, risk management, ISO 14971/24971, and 21 CFR 820.
• 7 years of experience in developing drug delivery devices, combination products and/or pharmaceuticals.
• Experience working in multi-disciplinary teams as well as working independently in ambiguous situations/assignments, gathering input from colleagues and management to address issues
• Demonstrated influencing and negotiating skills. High awareness of personal limits and a willingness to proactively consult others to ensure quality of judgement

PREFERRED QUALIFICATIONS

• The combination of strong pharmaceutical and medical device development experience preferred. Master's degree preferred.
• Strong leadership, negotiation, interpersonal, communication, and facilitation skills.
• Extensive experience in risk management and design control of medical devices or combination products from concept through launch
• Proven ability to succeed in a fast-paced, challenging, and complex environment.
• Experienced leading a program/project through a full life cycle. Working knowledge of product lifecycle management (PLM) system approach to risk management documentation and relation to Device Master Records (DMR)
• Proven ability to mentor junior engineers

PHYSICAL/MENTAL REQUIREMENTS

• The successful candidate will be capable of independent problem solving and working with minimal direction under most circumstances.
• The successful candidate will also possess strong oral and written communication skills.
• Strong analytical and computer skills are required.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

• Typically, less than 10%.

Other Job Details:

• Last Date to Apply for Job: July 25, 2022
• Eligible for Employee Referral
• Eligible for Relocation Package
• Work Location Assignment:Flexible

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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.

Research and Development

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