Systems Engineering Manager
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Job Location:
North Chicago, IL - USA
Monthly Salary:
Not Disclosed
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
AbbVie is looking for a Systems Engineering Manager to join their Product Development Science and Technology Systems Engineering team to contribute to the development launch and maintenance of medical devices and drug / device combination products.
As our Systems Engineering Manager you will be responsible for managing a team of Systems Engineers and integrating input from multiple disciplines to assure accurate and compliant Design History Files and robust patient-centric product performance.
Responsibilities:
Your engineering team is responsible for the accurate and compliant management of on-market Design History Files (DHFs) for medical devices and combination products within the scope of systems engineering. You are responsible to lead your team to ensure that all DHF documentation adheres to regulatory standards (e.g. FDA 21 CFR 820.30 ISO 13485 ISO 14971) and company procedures supporting product development design changes regulatory submissions and audit readiness. Your team will also support lead systems engineers to establish risk management files and design validation activities for new product introductions.
In addition to product support you will also be responsible to standardize and simplify systems engineering activities to enable more efficient development and marketed product support.
Skills / Experience:
- Management experience is required that includes managing internal and external engineering teams.
- Experience is required with identifying and deploying new methods and approaches within an organization.
- Experience is required with medical device or combination products including: product requirements: DHF traceability impact assessment and change management risk management and design validation.
- The candidate must be familiar with device design controls to enable new product introduction and lifecycle management.
- Other attributes include strong problem solving decision making negotiation and communication (spoken and written) skills. It is expected that you will identify and lead continuous improvement initiatives within systems engineering and the broader combination product organization to improve compliance operational efficiency with product development and lifecycle management. This position may include interfacing with 3rd party vendors.
Physical Job Requirements:
- Travel will be required as necessary. (10%)
Qualifications :
- Bachelors Degree in Engineering science or closely related discipline is desired or equivalent technical experience plus demonstrated competence. Advanced degree in a technical field preferred.
- 8 years experience including: work as an individual contributor building technical expertise and proved project management skills. Progressively increased responsibility and performance as a supervisor department manager in multiple areas of Operations. Post-graduate degree may contribute towards the desired years of experience.
- Business acumen coupled with leadership experience is required to drive high performance.
Additional Information :
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location and we may ultimately pay more or less than the posted range. This range may be modified in the future.
We offer a comprehensive package of benefits including paid time off (vacation holidays sick) medical/dental/vision insurance and 401(k) to eligible employees.
This job is eligible to participate in our short-term incentive programs.
This job is eligible to participate in our long-term incentive programs
Note: No amount of pay is considered to be wages or compensation until such amount is earned vested and determinable. The amount and availability of any bonus commission incentive benefits or any other form of compensation and benefits that are allocable to a particular employee remains in the Companys sole and absolute discretion unless and until paid and may be modified at the Companys sole and absolute discretion consistent with applicable law.
AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more visit & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:
No
Employment Type :
Full-time
Key Skills
- Hospitality Experience
- Go
- Management Experience
- React
- Redux
- Node.js
- AWS
- Mechanical Engineering
- Team Management
- Leadership Experience
- Mentoring
- Distributed Systems
About Company
AbbVie is a global biopharmaceutical company focused on creating medicines and solutions that put impact first for patients, communities, and our world. We aim to address complex health issues and enhance people's lives through our core therapeutic areas: immunology, oncology, neuro ... View more
