Sr. Systems Engineer, Device and Combination Products

Job Description

The Senior 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 RESPONSIBILITIESAs a Senior 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 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.
BASIC QUALIFICATIONS
• Bachelors 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.
• 5 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.
PHYSICAL/MENTAL REQUIREMENTSThe 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.,

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