Sr. Development Quality Engineer
SEDAAPleasanton, CA, US5 days ago
Job type
- Full-time
Job descriptionLead and / or support on-time completion of Design Control deliverables Support the establishment of objective, measurable, and verifiable product requirements Support Design Verification and Validation planning & execution, including any cross-functional investigation & resolution activities Lead Risk Management activities from product concept through commercialization Support test method development and lead test method validation activities Support manufacturing process development & qualification for new product and design changes Support the establishment of component specification definitions, supplied component sampling plan development, and vendor qualifications Support biocompatibility and sterilization qualifications Support audits and quality system improvement activities Support Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and regulatory requirements. Comply with Abbott, U.S. FDA, EUMDR and other requirements, as applicable. Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and suppliers. Bachelor’s degree in Engineering or Technical Field. Minimum of 5 years of experience in R&D, Process / Manufacturing Engineering, and / or Quality with at least 2 years supporting product development. Experience in medical devices and associated regulations / standards. Experience in test method development and validation Experience in preparing risk assessments, FMEA and other risk documents. Advanced Degree in Engineering / Technical Field Experience in active implantable medical devices. Knowledge of requirements management tools (e.g., DOORS) and use of problem reporting systems (e.g., JIRA). Working knowledge of statistics and its application to verification and validation? LOCAL CANDIDATES TO MINNETONKA, MN OR OPEN TO RELOCATE NO C2C The candidate will contribute to the design and development of medical devices, ensuring that all products meet defined specifications and comply with applicable regulatory standards. Collaboration with engineering, quality, and regulatory teams will be essential to drive innovation and maintain compliance throughout the development process. Strong communication and collaboration skills are critical, as this role requires facilitating effective interactions among cross-functional teams and stakeholders. The ability to foster alignment and transparency across departments will be key to project success. In addition, the candidate will participate in and oversee product testing and validation activities to ensure that devices meet performance, safety, and quality requirements. Coordination with relevant teams will be necessary to support verification and validation efforts. Finally, the role includes preparing and maintaining documentation to support regulatory submissions and product lifecycle management. All documentation must be accurate, complete, and compliant with industry standards and internal policies. LOCAL CANDIDATES TO ST. PAUL, MN OR OPEN TO RELOCATE NO C2C Performs testing of electronic components and assemblies using automated test equipment May perform mechanical assembly of electromechanical subassemblies and devices Ability to read, comprehend and follow written procedures; understand and follow verbal instructions. May instruct others in the use of all manuals, test procedures and documentation associated with specialized equipment. Reads and interprets engineering drawings, schematics and complex test procedures. Participates in continuous improvement / quality initiatives in order to enhance production processes to achieve quality and profitability metrics. Maintains accurate records to ensure Device History Records and quality documents are accurate, all parts are traceable and quality issues can be addressed to assure the quality of all products. Prioritizes work by determining the sequencing and timing of different jobs based on precedence and importance. Positively represents the company during tours by demonstrating techniques and sharing appropriate information. Supports all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements. Complies with U.S. Food and Drug Administration (FDA) regulations, ISO or other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Adheres to all environmental, health and safety SOP’s, equipment, policies and procedures, including any department specific requirements. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors. Experience with electronic assembly and test in a medical device industry preferred. High School Diploma or equivalency is required, preferred AAS 2 or more years experience with electromechanical assemblies / electronic manufacturing, technical certifications, etc. preferred Experience in troubleshooting equipment, building and or testing of electronic assemblies Working knowledge of IPC standards and use of complex tools and equipment specific to functional areas Experience in GMP, ISO, and FDA controlled environments preferred Ability to work within a team and as an individual contributor in a fast-paced, changing environment. Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization. Multitasks, prioritizes and meets deadlines in timely manner. Strong organizational and follow-up skills, as well as attention to detail. Ability to maintain regular and predictable attendance. Ability to work scheduled overtime as required is preferred. Ability to hand and lift up to 25 lbs. as needed for specific job functions Must be able to sit and / or stand for long periods of time. Ability to frequently sit, stand, walk, reach within hands and arm’s length, stoop, kneel and crouch.
Job Description
Job Description
- LOCAL CANDIDATES TO PLEASANTON, CA OR OPEN TO RELOCATE
- NO C2C
Job Title : Sr. Development Quality Engineer
Location : Pleasanton, CA (ON-SITE)
ID# SEDAA 42740
PAY RANGE : 70K - 95K / Annum
Description :
The Sr. Development Quality Engineer will serve as a technical representative providing design quality expertise to a product development team. Responsible for maintaining a strong collaborative partnership with cross-functional team members to achieve patient / user safety, customer satisfaction, and organizational success.
RESPONSIBILITIES :
Basic Qualifications :
Preferred Qualifications :
Job Title : Engineer, Research & Development
Location : Minnetonka, MN (ON-SITE)
ID# SEDAA 42525
PAY RANGE : 50K - 64K / Annum
Description :
A qualified professional to lead and support medical device development projects through comprehensive project management and technical expertise. This role involves developing and maintaining detailed project plans, budgets, schedules, and risk registers to ensure successful execution and alignment with organizational goals.
Job Title : Test Technician
Location : Irving, TX (ON-SITE)
ID# SEDAA 42510
Training Days 8 : 45 to 3 : 30 Monday 7 : 00 to 3 : 30 Tuesday 6 : 00am to 2 : 30 next 8 days
PAY RANGE : 30K - 34K / Annum
Description :
Job Summary :
Working under general supervision, this position is responsible for the production of high-quality medical device instruments. This position includes detailed assembly and testing of various electronic components and finished devices in a controlled manufacturing environment.
Job Responsibilities :
Minimum Qualifications :
Preferred Qualifications :
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Sr Quality Engineer • Pleasanton, CA, US
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