[ref. w00967524] Senior Manager, Process Development (Engineering)
Advanced Bionics LLC Valencia
HOURS: Full-time, 40 hours per week
SALARY: $157,414-$180,000 per year
EMPLOYER: Advanced Bionics LLC
JOBSITE: 28515 Westinghouse Place
Provide leadership to engineering staff regarding electronic devices and assemblies, project prioritization, technology development, and continuous improvement activities. Use good oral and written communication skills to review and coordinate staff resources, and maintain a highly qualified engineering team by offering performance feedback, training, mentoring, and coaching.
Implement quality management systems (QMS) to improve quality systems validation practices and procedures. Responsible for talent management and development, and oversee process validation and verification to ensure product quality and regulatory requirements are met.
Prepare budgets, schedules, and resource loading for assigned projects. Oversee the progress of projects, ensuring projects meet the relevant costs, schedules, performance goals, and sustaining engineering efforts. Identify, organize, plan, track, and improve issues related to design, quality, reliability, and costs for new and existing products.
Conduct return on investment (ROI) analysis for capital equipment purchases, and communicate plans and ideas to R&D directors and senior executives. Develop and manage quality engineering design standards to ensure all products meet or exceed applicable environmental and regulatory standards for Class III medical devices.
Hold regular project meetings with departmental level staff and management to present project status, problem-solving results, and to participate in the review process. Participate in presentations at general company meetings regarding department activities, product quality, product reliability, product performance, manufacturing issues, and department projects.
SALARY: $157,414-$180,000 per year
EMPLOYER: Advanced Bionics LLC
JOBSITE: 28515 Westinghouse Place
Valencia, CA 91355
Job Duties:
Manage the process development team in the creation of assembly processes, equipment, and tooling for the manufacturing of cochlear implant products. Lead the automated test equipment (ATE) team in developing, validating, sustaining, and improving test stations for new and current medical device products and components for Advanced Bionics and its vendors.Provide leadership to engineering staff regarding electronic devices and assemblies, project prioritization, technology development, and continuous improvement activities. Use good oral and written communication skills to review and coordinate staff resources, and maintain a highly qualified engineering team by offering performance feedback, training, mentoring, and coaching.
Implement quality management systems (QMS) to improve quality systems validation practices and procedures. Responsible for talent management and development, and oversee process validation and verification to ensure product quality and regulatory requirements are met.
Prepare budgets, schedules, and resource loading for assigned projects. Oversee the progress of projects, ensuring projects meet the relevant costs, schedules, performance goals, and sustaining engineering efforts. Identify, organize, plan, track, and improve issues related to design, quality, reliability, and costs for new and existing products.
Conduct return on investment (ROI) analysis for capital equipment purchases, and communicate plans and ideas to R&D directors and senior executives. Develop and manage quality engineering design standards to ensure all products meet or exceed applicable environmental and regulatory standards for Class III medical devices.
Hold regular project meetings with departmental level staff and management to present project status, problem-solving results, and to participate in the review process. Participate in presentations at general company meetings regarding department activities, product quality, product reliability, product performance, manufacturing issues, and department projects.
Domestic and international travel (California, Oregon, Ohio, Switzerland, Mexico) to manufacturing sites, office locations, and vendors (up to 10%). Manages 1 Principal Process Engineer, 2 Senior Test Engineers, 1 Senior Systems Engineer, 1 Senior Manufacturing Engineer, 1 Test Engineer, 2 Senior Test Technicians, 1 Senior Engineering Technician, 1 Process Development Intern, and 2 Contingent Test Engineers.
Requirements:
- Bachelors degree in Biomedical Engineering, Electronics/Electrical Engineering, or a related engineering field, and 4 years of experience as an Engineering Manager or related managerial occupation in the medical device manufacturing industry.
- Must have experience with the following:
- Project Management
- Return on Investment (ROI) Analysis
- Process Development
- Automated Test Equipment (ATE)
- Class III Medical Devices
- Manufacturing Processes
- Electronic Devices and Assemblies
- Quality Management Systems (QMS)
- Talent Management and Development
- Process Validation and Verification
- Must have good oral and written communication skills.
- Domestic and international travel (California, Oregon, Ohio, Switzerland, Mexico) to manufacturing sites, office locations, and vendors (up to 10%).
To Apply, Email Resume to: Attn: S. Spatrisano-Saenz/RE: SMPDE
Scarlett.Spatrisano-Saenz@advancedbionics.com
Valencia (CA)
OPPORTUNITY: LEASING CONSULTANT - VALENCIA, CA
**DAYS REQUIRED: TUESDAY - SATURDAY**
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