The Senior Validation Engineer will be responsible for planning, performing and documenting product validation and HFE (Human Factors Engineering) / UE (Usability Engineering) activities of a complex electro-mechanical systems with software. It includes testing of User Needs and Design Inputs for electro-mechanical systems to ensure that the product works for the end user as intended. The engineer is experienced in all aspects of product development life cycle with strong understanding of medical devices design verification, design validation and Human Factors. This person will work with a multi-disciplinary engineering teams including software, electrical, and mechanical design engineers, and other product development function members to ensure validated product introductions for class II medical devices.
- Lead the validation and HFE / UE activities for complex electro-mechanical medical device products within the Product Development team
- Responsible for planning, coordinating, performing and documenting Validation and HFE / UE activities ensuring related international standards are applied
- Develop and maintain HFE / UE and design Validation plans, protocols and reports
- Translate User Needs and Intended Use(s) into test Validation and HFE / UE protocols and validate that system works for the end user as expected and intended
- Build Validation Lab and provide validation and HFE / UE direction and oversight of Validation Testing and HFE / UE in the Lab
- Perform and document design Verification activities if required, depending on existing program needs
- Support development of acoustic and thermal energy delivery devices using HFE / UE best practices and in accordance with current regulations and guidelines within the medical device industry
- Contribute to risk analysis activities for the product development including providing inputs and reviewing hazards analysis, Design FMEA, and Use FMEA
- Collaborate with internal and external partners and across functions with stakeholders, engineering, design, commercial, quality, and regulatory teams
- Support project study design, methodology, data collection, root cause analysis to inform design and apply sound HFE / UE knowledge, experience and best practices to research, development, clinical studies, product verification and validation in support of regulatory submissions
- Master of Engineering or related technical field
- A strong technical background in medical device verification, validation or similar
- 10+ years of experience in regulated industry validating and performing HFE / UE activities for complex electromechanical systems
- Strong understanding of Design Controls for medical device development including experience with medical device product life-cycle processes conforming to standards including ISO 13485, IEC 62366, IEC 62304, EU MDR, and ISO 14971
- User center design / human center design experience
- 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 performing HFE / UE activities for high and low temperature, high acoustic, and high liquid pressure systems
- Experience writing User Manuals and Work Instructions
- An enthusiastic team builder and player
- Strong communication, written and personal computer skills
- Ability to earn trust, maintain positive and professional relationships, and strengthen our culture of inclusion
Desired Skills & Experience
- 2+ years of experience performing design verification activities
- Experience in medical device Software Verification or Validation
- Experience performing Hardware and / or Software system verification testing
Applicable to California Applicants Only
- The below range is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting. We may ultimately pay more or less than the posted range and this range is only applicable for jobs to be performed in California.
This range may be modified in the future.
- The salary range is (minimum: _$110,500__ to maximum:_$216,000___)
- This job is eligible to participate in our short-term incentive program
- This job is eligible to participate in our long-term incentive programs
- We offer comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
- 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 discretion unless and until paid and may be modified at the Company’s sole discretion, consistent with the law.
AbbVie is an equal opportunity employer including disability/vets. 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 disabled veteran, recently separated veteran, Armed Forces service medal veteran or active duty wartime or campaign badge veteran or a person’s relationship or association with a protected veteran, including spouses and other family members, or any other protected group status. We will take affirmative action to employ and advance in employment qualified minorities, women, individuals with a disability, disabled veterans, recently separated veterans, Armed Forces service medal veterans or active-duty wartime or campaign badge veterans. The Affirmative Action Plan is available for viewing in the Human Resources office during regular business hours.
出差: Yes, 5 % of the Time