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Senior Systems Engineer, Device and Combination Products

Lake Forest, IL 60045
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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, 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 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.

This position is responsible for creating and maintaining user requirements, product requirements, risk files, establishing and publishing traceability and support product usability under the coaching of a senior member on the team. In compliance with CFR 820 and corporate procedures, this position will be responsible for documentation generated in support of product development and submissions, and may also be responsible for on-market product documentation.


+ Develops the Design History File Structure and Owns the use case, user needs and product requirements, and risk management file (Hazard Analysis, FMEAs, and Traceability Matrix).

+ Primary responsibility for project DHF content generation in support of regulatory submissions with compliance to governing procedures and CFR 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

+ Partner with Human Factors and other functions within the organization to develop use FMEA ensuring use errors or misuse are mitigated, product and stakeholders' requirements are addressed and met as appropriate; providing risk and systems engineering input to cross functional teams and to instill a spirit of collaboration throughout the organization.

+ Integrates multiple approaches to solve problems or optimize solutions in complex or cross functional manufacturing processes or product designs. Integrates subsystems and components in total systems designs; develops specifications from ISO standards, customer requirements and stakeholders with Use Case.

+ Supports Combination Product inspection readiness and regulatory responses as needed

+ Mentors or provides guidance to other junior Systems engineers as needed.

+ Participate on continuous improvement teams to align on best practices with other Pfizer combination product teams



+ BS with 2-5 years experience, MS with 1-2 yrs experience in medical device or combination product industry, or anPhD Biomedical, Materials, Mechanical, Industrial Engineering with 0-1 years of experience.

+ Required: Understanding of FDA and working knowledge of 21CFR 820.30 Design Controls, ISO 13485 and ISO 14971 Application of Risk Management to Medical Devices

+ Demonstrated experience in Medical Device or Combination Products which include but not limited to Design Controls, Device Risk Management (risk identification, analysis, evaluation and risk Controls)

+ Ability to communicate clearly with team members and proficiency in facilitating effective meetings for document reviews


+ Systems Engineering experience and knowledge of Usability or human factors requirements in medical devices or combination products

+ Experience with DOORS requirements management software

+ Working knowledge of CFR part 4

+ Attention to details and demonstrate critical thinking skills

+ Ability to manage multiple complex projects with minimal supervision

**Other Job Details:**

+ **Last Date to Apply for Job: April 22, 2020**

+ Eligible for Relocation Package: No

+ Eligible for Employee Referral Bonus: Yes


**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.

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Posted: 2020-03-25 Expires: 2020-04-25

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Senior Systems Engineer, Device and Combination Products

Lake Forest, IL 60045

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