Systems/Biomedical Engineer
Systems/Biomedical Engineer
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Salary Not Disclosed
1 Vacancy
Job Description
AbbVie is looking for a systems engineer to join the Devices and Combination Product Development team. This individual will contribute to the development of exciting new drug / device combination products for various phases of clinical studies and work closely with cross-functional colleagues in operations as programs transition to commercial development. These devices enable the delivery of innovative medicines targeted at difficult-to-cure diseases with the goal of making a remarkable impact on peoples lives.
As an engineer you will be responsible for the integration of multiple disciplines to ensure robust patient-centric product design and performance. In this role you will be working with a global team of exceptional scientists engineers and leaders on a variety of drug delivery systems from syringes to autoinjectors to complex electromechanical pumps. Your support will ensure these systems are safe and effective in meeting their intended use for clinical and commercial development programs.
This position is based in Lake County IL US.
Core Job Responsibilities:
This position focuses on implementation of system engineering principles for development of drug/device combination products for clinical studies including:
- Authoring and maintaining Design Inputs Risk Management files System Architecture Change Management and traceability .
- Developing strategic plans for Design History Files
- Collaborating with internal stakeholders including: Commercial Operations Quality and R&D
- Interfacing with 3rd party development partners and engineering services.
- Contribute to raising the bar on how we develop combination products. This includes the identification and leadership of improvement initiatives and look for new ideas to stimulate innovation and connect unrelated concepts generate original or unique ideas.
- Some travel required
Qualifications :
Minimum Qualifications:
- BS Engineering with 2 years related work experience OR MS Engineering with 0 years of related work experience
- Degree in Biomedical Electrical Mechanical engineering or a related field from an accredited college or university.
- Experience is desired in device/combination product Design Controls and Design History Files (DHF) including: user and stakeholder need definition; risk management (ISO 14971); requirements gathering requirements definition (includes standards decomposition); traceability; and system architecture.
Preferred Qualifications:
- Experience in medical device or combination product development is a bonus with familiarity with device standards and regulations including: FDA 21 CFR Part 820.30 ISO 13485 and MDR.
Other Required Skills:
- The candidate must have strong communication and influencing skills the ability to find the way forward through ambiguity solid decision-making skills and the ability to find creative solutions.
- The candidate must have strong technical writing skills to communicate unambiguously with technical and regulatory audiences.
- This position will include interfacing with 3rd party vendors. Experience in vendor communication and management will help make you successful in this position.
- Travel will be required as necessary. (10%)
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.
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
Employment Type
Full-time
