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
- 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
- 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
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT 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.
Other Job Details:
- Typically, less than 10%.
#LI-PFEPfizer 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
- 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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Research and Development