Senior Project Engineer

Company Description

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Job Description

Key Responsibilities

• Ensure quality & effectiveness of key results of major projects within function through sound design, early risk assessments, & implementation of fallback strategies.
• Responsible for compliance with applicable policies & procedures.
• Responsible for potential consequences (defects & failure modes) of design changes to established processes.
• Mitigate risk within functions through sound design, early risk assessments & implementation of fallback strategies.
• Plan & conduct high business impact projects within engineering specialty in Medical Devices, Manufacturing, & Packaging.
• Responsible for achieving project's timeline targets in support of business objectives. Maintain project controls & reporting for cost, scope, & schedule.
• Balance multiple demands & understand business needs with a thorough knowledge of the medical device, customer needs, & regulatory requirements when developing a project scope.
• Responsible for preparing documentation packages for presentation to management & for regulatory requirements.
• Produce unique & cost-effective results.
• Establish alternate use possibilities & incorporate flexibility.
• Balance system costs with benefits provided.
• Oversee design work of internal & external consultants.
• Create & modify designs for intermediate problems.
• Analyze complex interdisciplinary problems & identify their impact, establish probabilities, & draw conclusions reflecting broad product development needs.
• Represent engineering on corporate task forces.
• Identify full range of customer/client needs & propose solutions to address them.
• Responsible for alterations in products or services to better meet (recognized or unrecognized) customer needs.
• Monitor improvement of other engineers & participate in evaluation of assigned staff/project team members & in the identification of development needs.

Qualifications

Education & Experience

Must possess a Bachelor's degree or foreign academic equivalent in Mechanical Engineering, Biomedical Engineering, Electrical Engineer, or a highly related field of study with 5 years of experience; in the alternative, employer will accept a Master's degree in the aforementioned fields & 2 years of related work experience.

Each alternative with 2 years of experience in:

experience with medical device product development utilizing design controls & change controls within the guidance of FDA Title 21 CFR part 820 & ISO 13485;

Knowledge of EU Medical Device Directive & transition to EU Medical Device Regulation;

experience with design verification, as both originator & reviewer;

experience with Process Development, Process Control Strategy, Test Method Development, Design Verification & Validation, Process Validation, Change Control, Change Management, & Technical Protocol & Report Authoring.

Employer will accept any suitable combination of education, training or experience related to the job opportunity.

Additional Information

Up to 25% international & domestic travel required.

Salary Range: $155,750 - $173,500 per year

Apply online at https://careers.abbvie.com/en. Refer to Req ID: REF35116L

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 and long-term incentive programs.

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 https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html