Senior Technical Lead

Job FamilyEngineering (Engineering - Hardware) Job Description (Posting).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 (1.) To be responsible for providing technical guidance or solutions (2.) To develop and guide the team members in enhancing their technical capabilities and increasing productivity (3.) TO ensure process compliance in the assigned module, and participate in technical discussionsorreview. (4.) To prepare and submit status reports for minimizing exposure and risks on the project or closure of escalations.QualificationB.E No. of Positions1Skill (Primary)Technical Skills (ERS)-Electromechanical Development-Electrical Engineering Employee GroupBusiness Line FT CityAlameda CountyEntityCSWAuto req ID1153443BRExpected Date of Closure01-Oct-2022Location: California Experience: 9-11 Years Country: USA