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AbbVie Associate Director, Systems Engineering in Pleasanton, California

About AbbVie

AbbVie’s mission is to discover and deliver innovative medicines 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, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on Twitter (https://twitter.com/abbvie) , Facebook (https://www.facebook.com/AbbVieGlobal) , Instagram (https://www.instagram.com/abbvie/?hl=en) , YouTube (https://www.youtube.com/user/AbbVie) and LinkedIn (https://www.linkedin.com/company/abbvie) .

Summary:

A proven and experienced engineering leader, this individual is responsible for the system engineering function within the body contouring R&D team. The person shall be experienced in all aspects of product development with emphasis on systems engineering processes with a strong understanding of a complex electro-mechanical system with software. The person will lead User Needs definition, system requirements development, risk assessment, usability engineering, and systems integration. The individual is a champion of cross functional collaboration, both within R&D and across the broader development team.

Essential Duties and Responsibilities include the following (other duties may be assigned.):

  • Within the Product Development team lead the systems engineering activities for complex electro-mechanical medical devices.

  • Translate customer needs, research findings and business requirements into product requirements and specifications.

  • Ensure system design and appropriate supporting documentation meets all safety and regulatory compliance.

  • Develop Strategies for Design Verification and Validation across multiple device types.

  • Develop and implement processes to support product development activities from a system perspective, e.g. requirements management, defect tracking.

  • Develop and maintain product specifications, requirements documents, hazards analysis, design FMEA, usability, design Verification & Validation documentation, and other technical documentation.

  • Communicate and collaborate with a wide range of project contributors and stakeholders spanning the organization, and external partners.

  • Lead risk analysis activities for the product development including system Application and Design FMEA.

  • Collaborate with technical leaders for product design, development, integration, testing, and reliability improvements.

  • Define usability evaluation plans and conduct and coordinate usability testing activities and ensure usability engineering is applied according to international standards

Qualifications

  • Bachelor’s/Master’s Degree in Engineering with specialization in medical device development with 10 years of relevant work experience

Additional Requirements:

  • Experience with medical device design and development processes that conform to standards including: ISO 9000, ISO 13485, IEC 62304, IEC 60601, IEC 62366, and ISO 14971.

  • Requires at least 5 years of technical leadership or program management experience

  • Strong understanding of Design Controls for medical device development.

  • Strong understanding of project/program management is required with an understanding of the FDA product development process. and understanding of PLM are a plus.

  • Demonstrated experience in driving design for manufacturability and service.

Language and Verbal Skills:

Individual must have excellent verbal and written communication skills and a demonstrated ability to communicate clearly and professionally.

Math Skills:

Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.

Analytical and Reading Skills:

Ability to read, understand and abide by company procedures. Ability to define problems, collect data, establish facts, draw valid conclusions and report on findings.

Physical Requirements:

The physical demands and work environment described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to sit, stand, walk, talk and hear; up to 8 hours per day. The employee is regularly required to lift and carry up to 10 pounds and occasionally lift and carry up to 25 pounds. Duties also involve daily keyboard data entry. Specific vision abilities required by this job include close vision.

Work Environment:

Most work is performed in an office-like setting. The noise level in the environment is usually low to moderate.

Safety:

Allergan is committed to the health and safety of our employees. We expect that all employees will perform their responsibilities while maintaining a safe, cooperative, and productive work environment, thus ensuring the health and safety of themselves and others.

Significant Work Activities

Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)

Travel

No

Job Type

Experienced

Schedule

Full-time

Job Level Code

IC

Equal Employment Opportunity

At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.

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