Quality Engineer I- Shockwave Medical

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are our expertise in Innovative Medicine and MedTech we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for more at

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Johnson & Johnson is hiring for a Quality Engineer I Shockwave Medical to join our team located in Santa Clara CA.

At Johnson & Johnson we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented treated and cured where treatments are smarter and less invasive and solutions are personal. Through our expertise in Innovative Medicine and MedTech we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity. Learn more at by innovation at the intersection of biology and technology were developing the next generation of smarter less invasive more personalized treatments. Ready to join a team thats pioneering the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. Our Shockwave Medical portfolio 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 Design Quality Engineer I supports Quality Assurance Design Development activities related to IVL catheters partnering with internal customers and stakeholders to identify risks and improvement opportunities using data. This position will primarily support IVL catheter new products development and sustaining activities in accordance with applicable quality and regulatory standards including ISO 13485 ISO 14971 ISO 10555-1 21 CFR Part 820 MDD 93/42/EEC EU MDR MDSAP IEC 62304 IEC 62366 and IEC 60601. The position requires upholding with Johnson & Johnsons Credo and Leadership Imperatives and their application in day to day interactions.

Essential Job Functions

• Perform biannual updates to commercial Risk Management Files using post market surveillance data.
• Review/approve complaints and ensure accurate linkages to associated risks in products Risk Management Files.
• Review/approve clinical annual updates (e.g. LSP LSR PMCFP CEP CER).
• Participate in data integrity initiative for Verification & Validation activities. Review test and inspection data to ensure compliance with Good Documentation Practices (GDP).
• Audit data collection processes for GDP compliance.
• Collect Prepare and present risk management data to management representatives prior to periodical management review.
• Familiarity with inspection and functional testing using various measurement systems per specifications test protocols.
• Audit Design History Files (DHFs) for Design Control procedure compliance.
• Author technical documentation with sufficient clarity detail and correctness to be submitted for regulatory review with confidence (e.g. inspection/testing procedures development studies verification/validation protocols and reports quality plans).
• Review investigate disposition and close Non-conforming Reports (NCR) or Corrective and Preventive Actions (CAPA) as assigned.
• Initiate review and approve Document Change Orders (DCO)
• Use statistical tools and software (e.g. Minitab) to perform process capability and data normality assessments analysis of variance hypothesis testing determining appropriate sample sizes tolerance interval assessments for variable and attribute data and variable and attribute sampling plan s.
• Demonstrate and apply Johnson & Johnsons Credo and Leadership Imperatives in day-to-day interactions with team.
• Demonstrate teamwork integrity and commitment to patient safety and product quality.
• Adhere to company policies quality systems and regulatory requirements.
• Perform other duties as assigned

An internal pre-identified candidate for consideration has been identified. However all applications will be considered.

Requirements

• BS in a related engineering discipline (Mechanical Electrical Biomedical or equivalent); some related experience is preferred.
• No Prior professional experience required; internship co-op or relevant coursework in the medical device industry is preferred.
• Strong technical writing and verbal skills are required
• Proactive self-motivated and able to work with moderate supervision as responsibilities grow
• Able to work in the Controlled Environment Room (CER)
• Some travel may be required
• Effective communication skills with peers and direct levels of management.
• May be required to lift objects up to 25 lbs.
• Ability to read and interpret technical specifications and mechanical drawings.
• High attention to detail and accuracy is required
• Proficiency in MS Word MS Excel and MS Power Point required
• Operate with adaptability to changing requirements
• Able to work in a fast-paced environment managing multiple priorities

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity age national origin disability protected veteran status or other characteristics protected by federal state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants needs. If you are an individual with a disability and would like to request an accommodation please email the Employee Health Support Center () or contact AskGS to be directed to your accommodation resource.

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