Quality Engineer I- Shockwave Medical

Johnson & Johnson Innovative Medicine•Santa Clara, CA

9d•$62,000 - $100,050•Onsite

About The Position

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 https://www.jnj.com/. Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Ready to join a team that’s 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 & Johnson’s Credo and Leadership Imperatives and their application in day to day interactions.

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

Responsibilities

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 & Johnson’s 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

Benefits

Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company’s long-term incentive program.
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits: Vacation –120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year Holiday pay, including Floating Holidays –13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year Caregiver Leave – 80 hours in a 52-week rolling period10 days Volunteer Leave – 32 hours per calendar year Military Spouse Time-Off – 80 hours per calendar year

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