Hardware Design Quality Engineer- Medical Device Domain

*Job Title

Sr. Hardware Design Quality Engineer

Work Country

US

*Exact Location Candidate will be working at: Please provide full address if possible.

Northridge, CA

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*Experience Level Required.

• Bachelor’s Degree in Engineering or Science with 4+ years of work experience in Quality and/or Software Development OR Master’s Degree in Engineering or Science with 2+ years of work experience in Quality and/or Software Development.
• Experience working in a regulated industry (e.g., FDA-regulated).

*Job Description

• As a Quality Core Team member, collaborate with cross-functional project team members as well as members of the QA extended team.
• Demonstrate the ability and desire to work within a regulated medical device development environment, particularly based on the FDA Quality System Regulation and ISO 13485.
• Hands-on electromechanical, electronic, or electrochemical sensor design experience
• Identify and implement process improvements to increase efficiencies and product quality.
• Lead and drive collaborative design and development of medical devices.
• Participate in the development of requirements, hardware design, interface and test design.
• Collaborate & develop HW FMEA to help drive good designs at early development stages.
• Collaborate and develop system hazard analysis.
• Lead and drive CAPA projects.
• Collaborate effectively with the cross functional teams and other stakeholders.
• Demonstrate excellent coding, design and test practices.
• Understand the interdependencies of program work products and guide the teams in execution strategy and participating in development, review and approval of all program work products (e.g. plans, requirements, specifications, tests, test results, traceability, risk management documents, reports).
• Interact and form constructive working relationships with all levels of leadership within Quality, Marketing, R&D, Systems Engineering and Operations.
• Provide training and coaching to cross-functional peers in maintaining compliance to internal and external Quality requirements and regulations
• Participate and support external regulatory audits and inspections.
• Provide solutions to a wide range of difficult challenges. Work independently to determine and develop solutions that are imaginative, thorough, practicable, and consistent with organizational objectives.
• Performs other related duties as assigned.

*Specific Search Key Words I can use to find the right profile -.

Hardware quality, Quality Engineer, V&V engineer, Medical device, ISO13485

Must to have:
Hardware
Quality
Testing
Medical device

Adds Value:
ISO13485
ISO14971
60601-1
Automation

Good To Have
CSTE/CSQA certificate

*Education

Bachelor’s Degree in Engineering or Science with 5+ years of work experience in Quality and/or Software Development OR
Master’s Degree in Engineering or Science with 3+ years of work experience in Quality and/or Software Development.

*Recruiter Email Id

Required Skillset(s)

See job duties and Experience level required

Preferred Skillset(s)

• Master’s Degree in Engineering, Quality, Regulatory, or related.
• Working knowledge of embedded and mobile application development for medical devices.
• Working knowledge of ISO 13485, ISO 14971, 21 CFR 820, IEC 62304, IEC 60601-1 and MDD.
• Ability to author technical reports, business correspondence and standard operating procedures.
• Ability to apply knowledge and work with development and supply vendors to ensure compliance to Medtronic requirements.
• Strong verbal and written English communication skills with an ability to effectively communicate at multiple hierarchal levels in the organization.
• Ability to multi-tasks, prioritize, meets/exceed deadlines and hold themselves, and others accountable.
• Self-Starter with a sharp focus on quality and customer experience.