Shockwave Medical
Manager, Sustaining Quality Engineering (Hardware/Software)
Shockwave Medical, Santa Clara, California, us, 95053
Shockwave Medical, Inc. is a pioneer in the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. Shockwave Medical aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated and proprietary local delivery of sonic pressure waves for the treatment of calcified plaque.
Position Overview
The Manager, Sustaining Quality Engineering (HW/SW) provides leadership to the Sustaining Quality Engineering group and works closely with internal and external departments to efficiently deliver safe and effective medical devices to customers in compliance with Shockwave Medical (SWM) policies and procedures. This position will represent the hardware and software product life cycle management team. This position will support project teams to ensure that existing products are designed, developed and manufactured in accordance with customer, corporate, and regulatory guidelines and execute initiatives for continuity of supply chain, quality improvement, cost reduction, and product safety. This position provides Quality Assurance support to functions with a focus on process validation, process improvements, post market sustaining activities, and design control compliance in accordance with ISO 13485, ISO 14971, 21 CFR Part 820, MDD 93/42/EEC, EU MDR, MDSAP, IEC 62304, IEC 62366 and IEC 60601.Essential Job Functions
Oversee all aspects of sustaining quality activities as it relates to Hardware, Software and Systems engineering.Oversee and manage Quality Engineers and Technicians supporting sustaining quality engineering activities:Hire, support, and mentor direct reports to develop a highly effective team.Set goals for Quality personnel based on corporate objectives.Ensure Quality Personnel follow regulations and industry standards.Provide visible leadership and oversee daily activities.Develop and maintain budget.Provide support to Manufacturing and Operations (either at internal site or at external vendor site).Establish and maintain validated processes.Identify, drive, and implement process improvements.Participate in Supplier Quality activities including supplier selection and audits.Work with contract manufacturers to maintain product quality and resolve any non-conformances that arise.Support business scalability and continuous improvement projects.Actively participate in Design Control/Design Change/Supplier Change activities such as:Ensure design transfers to manufacturing are completed successfully and in a compliant manner.Maintain Risk Management File documents such as Risk Management Plan, ongoing Risk Analysis, Failure Mode and Effects Analysis (FMEA), Risk Management Reports etc.Ensure Sustaining projects and Design/Supplier Change activities are performed in compliance to regulations, standards, and internal procedures.Draft/Review/Perform Hardware and Software Verification and Validation Test Plan, Test Protocols, Methods, and Reports.Audit DHFs to ensure compliance to relevant procedures.Subject matter expert on application of relevant standards, test sample sizes and usage of statistical techniques for sustaining and design/supplier/process change projects.Drive Standard Gap Assessment activities.Ensure compliance to new country requirements prior to product release.Investigate and document results for returned devices from clinical studies and commercial complaints.Maintain and manage the Servicing Program and coordinate servicing activities with internal and external parties.Support Finished Goods distribution and commercial operations Quality activities.Support and assist in maintaining compliance with other areas of the QMS as needed (Non-Conformance, Complaints, CAPAs, Post Market Surveillance, Management Responsibility, Supplier Controls, Audit Support, etc.)Analyze, review and present data for key Quality metrics to identify any significant trends.Initiate, review, and approve Document Change Orders (DCO).Participate in internal, supplier and third-party audits (FDA, FDB, Notified Body, etc.).Support ongoing Regulatory submission activities and product approval processes.Participate in the implementation and continuous improvement of the Quality Management System.Provide technical support to the Quality inspection group.Other duties as assigned.Requirements
Bachelor of Science degree in Electrical/Software Engineering. Master's Degree preferred.10+ years of hands-on experience with Hardware and Embedded Software Design, with a minimum of 8 years in the Medical Device industry.Experience with Analog and Digital Circuit Design, schematic layouts, PCB Layout/ design and prototype development.Experience with embedded systems, source version control, Issue Tracking, and control electronics for use in medical devices and programming.2+ years of experience managing others, or other equivalent experience.Working knowledge of applicable medical device regulations and standards such as ISO 13485, ISO 14971, IEC 62304, IEC 60601, 21 CFR Part 820, MDD 93/42/EEC, EU MDR, and MDSAP required.Experience with statistical software such as Minitab and the application of valid statistical techniques for data analysis.Experience with Class III medical device experience and electromechanical device product is highly desired.Experience and involvement with complaint investigations is preferred.Ability to understand regulatory implications of Design/Process/Supplier Changes.Ability to lead cross-functional teams in problem solving and risk analysis activities.Must be able to communicate effectively with all levels of the organization in both verbal and written formats.Highly proficient in MS Word, Excel and Power Point.High attention to detail and accuracy is required.Ability to work in a fast-paced environment while managing multiple priorities.Operate as a team and/or independently while demonstrating flexibility to changing requirements.Employee may be required to lift objects up to 25lbs.Employee must be able to travel 25% of the time.Market Range:
$144,000 - $180,000Exact compensation may vary based on skills, experience, and location.Benefits
Shockwave Medical offers a competitive total compensation package as well as the following benefits and perks:Core Benefits:
Medical, Dental, Vision, Pre-tax and Roth 401k options with a fully vested match, Short-Term and Long-Term Disability, and Life Insurance, Employer contribution toward Health Savings Account (HSA), Competitive PTO balance.Perks:
Calm App, Pet Insurance, Student Loan Refinancing, Spot Bonus awards.EEO Employer
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Position Overview
The Manager, Sustaining Quality Engineering (HW/SW) provides leadership to the Sustaining Quality Engineering group and works closely with internal and external departments to efficiently deliver safe and effective medical devices to customers in compliance with Shockwave Medical (SWM) policies and procedures. This position will represent the hardware and software product life cycle management team. This position will support project teams to ensure that existing products are designed, developed and manufactured in accordance with customer, corporate, and regulatory guidelines and execute initiatives for continuity of supply chain, quality improvement, cost reduction, and product safety. This position provides Quality Assurance support to functions with a focus on process validation, process improvements, post market sustaining activities, and design control compliance in accordance with ISO 13485, ISO 14971, 21 CFR Part 820, MDD 93/42/EEC, EU MDR, MDSAP, IEC 62304, IEC 62366 and IEC 60601.Essential Job Functions
Oversee all aspects of sustaining quality activities as it relates to Hardware, Software and Systems engineering.Oversee and manage Quality Engineers and Technicians supporting sustaining quality engineering activities:Hire, support, and mentor direct reports to develop a highly effective team.Set goals for Quality personnel based on corporate objectives.Ensure Quality Personnel follow regulations and industry standards.Provide visible leadership and oversee daily activities.Develop and maintain budget.Provide support to Manufacturing and Operations (either at internal site or at external vendor site).Establish and maintain validated processes.Identify, drive, and implement process improvements.Participate in Supplier Quality activities including supplier selection and audits.Work with contract manufacturers to maintain product quality and resolve any non-conformances that arise.Support business scalability and continuous improvement projects.Actively participate in Design Control/Design Change/Supplier Change activities such as:Ensure design transfers to manufacturing are completed successfully and in a compliant manner.Maintain Risk Management File documents such as Risk Management Plan, ongoing Risk Analysis, Failure Mode and Effects Analysis (FMEA), Risk Management Reports etc.Ensure Sustaining projects and Design/Supplier Change activities are performed in compliance to regulations, standards, and internal procedures.Draft/Review/Perform Hardware and Software Verification and Validation Test Plan, Test Protocols, Methods, and Reports.Audit DHFs to ensure compliance to relevant procedures.Subject matter expert on application of relevant standards, test sample sizes and usage of statistical techniques for sustaining and design/supplier/process change projects.Drive Standard Gap Assessment activities.Ensure compliance to new country requirements prior to product release.Investigate and document results for returned devices from clinical studies and commercial complaints.Maintain and manage the Servicing Program and coordinate servicing activities with internal and external parties.Support Finished Goods distribution and commercial operations Quality activities.Support and assist in maintaining compliance with other areas of the QMS as needed (Non-Conformance, Complaints, CAPAs, Post Market Surveillance, Management Responsibility, Supplier Controls, Audit Support, etc.)Analyze, review and present data for key Quality metrics to identify any significant trends.Initiate, review, and approve Document Change Orders (DCO).Participate in internal, supplier and third-party audits (FDA, FDB, Notified Body, etc.).Support ongoing Regulatory submission activities and product approval processes.Participate in the implementation and continuous improvement of the Quality Management System.Provide technical support to the Quality inspection group.Other duties as assigned.Requirements
Bachelor of Science degree in Electrical/Software Engineering. Master's Degree preferred.10+ years of hands-on experience with Hardware and Embedded Software Design, with a minimum of 8 years in the Medical Device industry.Experience with Analog and Digital Circuit Design, schematic layouts, PCB Layout/ design and prototype development.Experience with embedded systems, source version control, Issue Tracking, and control electronics for use in medical devices and programming.2+ years of experience managing others, or other equivalent experience.Working knowledge of applicable medical device regulations and standards such as ISO 13485, ISO 14971, IEC 62304, IEC 60601, 21 CFR Part 820, MDD 93/42/EEC, EU MDR, and MDSAP required.Experience with statistical software such as Minitab and the application of valid statistical techniques for data analysis.Experience with Class III medical device experience and electromechanical device product is highly desired.Experience and involvement with complaint investigations is preferred.Ability to understand regulatory implications of Design/Process/Supplier Changes.Ability to lead cross-functional teams in problem solving and risk analysis activities.Must be able to communicate effectively with all levels of the organization in both verbal and written formats.Highly proficient in MS Word, Excel and Power Point.High attention to detail and accuracy is required.Ability to work in a fast-paced environment while managing multiple priorities.Operate as a team and/or independently while demonstrating flexibility to changing requirements.Employee may be required to lift objects up to 25lbs.Employee must be able to travel 25% of the time.Market Range:
$144,000 - $180,000Exact compensation may vary based on skills, experience, and location.Benefits
Shockwave Medical offers a competitive total compensation package as well as the following benefits and perks:Core Benefits:
Medical, Dental, Vision, Pre-tax and Roth 401k options with a fully vested match, Short-Term and Long-Term Disability, and Life Insurance, Employer contribution toward Health Savings Account (HSA), Competitive PTO balance.Perks:
Calm App, Pet Insurance, Student Loan Refinancing, Spot Bonus awards.EEO Employer
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