10 days old

Team Lead, Systems and Risk Management

Lake Forest, IL 60045
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The Systems and Risk Management 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 and control the development of new products including: intended use and user, requirements, risk analysis, and risk management controls. These are used in demonstrating compliance, safety and efficacy, and suitability of new products in submissions and for ongoing post-market control. The Systems and Risk Management function operates side-by-side with Human Factors Engineering as members of cross-functional product development teams.

The Team Lead position is responsible Systems and Risk Management team operational excellence and execution of key projects. This includes functional planning and resource modeling, management of external suppliers, continuous improvement of key processes, and consistency of outputs. This role requires strong subject matter command to lead key projects and functional initiatives, good communication skills, and leadership potential.


+ Project planning and resource modeling

+ Life Cycle Management of external service suppliers: supplier identification, project scoping, start-up, control and monitor of performance, and closure

+ Management of key initiatives to drive organizational alignment and functional continuous improvement

+ Review of outputs against established procedures and relevant regulatory requirements for consistency and compliance

+ Determine the DHF Structure and own 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

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

+ Partner with other functions in the organization to ensure stakeholder product requirements are addressed and met as appropriate; to provide consistent direction to cross functional teams and to instill a spirit of collaboration throughout the organization in new product development

+ Responsible for 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. Develop comprehensive assessment and report of Use, Design, and Process risk and mitigation to create the Risk Management Report

+ Provide evidence of DHF completeness and alignment through management of traceability utilizing industry best practices and technology

+ Support the generation of regulatory submission documentation and as necessary support internal and external audits


+ BS and 10 years experience (or) MS and six (6) years experience (or) PhD and four (4) years experience.

+ Engineering discipline or equivalent experience is required with Biomedical, Mechanical, Chemical, or Industrial Engineering degree preferred.

+ Understanding of FDA and EU regulations as well as expert working knowledge of CFR 820.30 Design Controls and ISO 14971 are required.

+ Six (6) years of relevant device or combination product Systems or Risk Management engineering experience.

**Additional Job Details**

+ Eligible for Relocation Package

+ Eligible for Employee referral bonus

+ \#LI-PFE

**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.

Posted: 2020-10-13 Expires: 2020-11-13
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Team Lead, Systems and Risk Management

Lake Forest, IL 60045

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