Staff Mechanical Engineer, Devices - Aesthetics

Location

Pleasanton, CA | United States

Job description

The Staff Mechanical Test Engineer will be responsible for leading, planning, performing and documenting system verification, integration and validation activities of complex electro-mechanical systems with software. It includes testing of requirements for electro-mechanical systems to ensure proper product components and product functionality. The engineer is experienced in all aspects of product development life cycle with strong understanding of systems engineering processes in a regulated industry. The Staff Mechanical Test Engineer will work with a multi-disciplinary engineering teams including software, electrical, and mechanical design and test engineers, and other functions to ensure high quality product introductions for class II medical devices. We are looking for a motivated self-starter who is energetic, has a ‘make it happen in a compliant way’ attitude and can thrive in a fast-paced environment.

Responsibilities:

• Lead the mechanical verification and engineering testing activities for complex electro-mechanical medical device products within the Product Development team
• Develop testing methods, identify sample sizes, perform testing activities, summarize and document test results, present test outputs to cross-functional team
• Provide test engineering direction and oversight of testing in the Lab; follow Laboratory Best Practices and safety protocols
• Translate Design Inputs into test protocols, and support creation of system architecture and detailed design documentation
• Develop and maintain system verification and integration planning document, verification protocols, verification reports, requirements documents, and other related technical documentation while ensuring related international standards are applied
• Contribute to risk analysis activities for the product development including hazards analysis, Design FMEA, and Use FMEA
• Ensure that inputs from research, product development and post market are effectively included in design verification related documentation, activities and outputs
• Prepare mechanical test environment and ensure test preconditions are met prior to formal testing activities
• Verify that system and mechanical design and appropriate supporting documentation meets all safety, regulatory and industry compliance standards, and codes while ensuring that related (including GxP, ISO 13485, IEC 60601-1, IEC 62366, IEC 62304, ASTM, and ISO 14971) standards are applied
• Safely work with hazardous systems containing high voltage, high / low temperatures, high acoustic, and high pressure
• Support review and approval of design and process changes as well as deviations related to new and existing medical device products
• Communicate and collaborate with a wide range of project contributors and stakeholders spanning the organization, and external partners including technical leaders for product design, development, integration, testing, and reliability improvements

• Master of Engineering or related technical field
• 10+ years of experience in regulated industry testing complex electromechanical systems
• Firm technical background within medical device testing, development, systems engineering or similar
• Strong understanding of Design Controls for medical device development including experience with medical device product life-cycle processes conforming to standards including GDP, ISO 13485, IEC 60601-1, IEC 62366, IEC 62304, ASTM, and ISO 14971
• Proficient in using Requirement Management and Traceability tools
• Technical leadership or program management experience with strong understanding of project / program management according to regulated product development process
• Hands-on experience with developing design verification protocols, execution, and report generation as well as with conducting mechanical verification of high and low temperature, high acoustic, and high liquid pressure systems
• Basic engineering laboratory skills: weights and measures, chemical hygiene, materials safety planning, personal protective equipment, contamination control, job hazard analysis, and work instruction
• An enthusiastic team builder and player
• Excellent communication, written and personal computer skills
• Ability to earn trust, maintain positive and professional relationships, and strengthen our culture of inclusion

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 Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law. 

AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community, and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because 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, status as a protected veteran, or any other legally protected group status.

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