Sr. Design Quality Engineer - Shockwave Medical

We need to output HTML fragment with headings

for sections: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. Only include sections that have real specific content. We must not repeat job title as heading. Must not include Job ID etc. Must preserve all substantive info, remove boilerplate (cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate, duplicated lines, application instructions). Also we must not include sections with filler like "commensurate with experience". We need to extract content. Let's parse the posting. First paragraph: "At Johnson & Johnson, we believe health is everything..." This is company overview, could be "About the role"? Actually "About the role" maybe includes description of role and company. The posting includes "Job Description" and "Position Overview". So we can put that under "About the role" or maybe "Responsibilities". The instructions: Use

for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). So we need to decide which sections to include based on content. We have: - About the role: Could include company mission, role overview, position overview. - Responsibilities: Essential Job Functions list. - Requirements: Bachelor's in software/electrical engineering with 5+ years... etc. - Qualifications: Might overlap with Requirements; but we can combine? The posting includes "Requirements" and also "Preferred Skills" later. There's also "Required Skills Preferred Skills:" list. So we can have "Skills" section for those. - Benefits: Additional Information includes compensation, bonus, benefits programs, time off. - Pay: The anticipated base pay range: $91,000 - $147,200. - Schedule: Not mentioned; no schedule info. So we should not include Schedule section. We must not include sections with placeholder like "commensurate with experience". Not present. We must not repeat job title as heading. We must not include Job ID/requisition numbers. We must remove boilerplate: EEO statement, accommodation request, etc. Also remove "Learn more at jnj.com", "As guided by Our Credo", maybe keep some Credo mention? The Credo mention is part of company overview; but it's somewhat boilerplate? It's not EEO but still generic. Might be okay to keep as part of About the role. However instructions: Remove cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate, duplicated lines, and application instructions. The Credo statement is not exactly legal boilerplate but could be considered generic. Might keep. We also need to preserve all substantive information. So we need to include details like job location Santa Clara, CA, job function, sub function, category, etc. Those are metadata; we can fold into a short

or drop it. The instruction: "do NOT put Job ID / requisition numbers as headings — fold minor metadata into a short

or drop it." So we can include location etc in a short paragraph under About the role maybe. We must not invent or summarize away detail. So we need to keep the specifics: e.g., "Sr. Design Quality Engineer – Shockwave Medical", location, etc. Let's extract substantive content: Company overview: At Johnson & Johnson, we believe health is everything... (the paragraph about mission). Also "As guided by Our Credo, Johnson & Johnson is responsible to our employees..." etc. Might be considered boilerplate but it's about company values; could be kept. Job Description: "Johnson & Johnson is hiring for a Sr. Design Quality Engineer – Shockwave Medical to join our team located in Santa Clara, CA." Position Overview: description of role. Essential Job Functions: bullet list (we need to convert to

• ). Requirements: bullet list? Actually it's a paragraph with requirements. Also there is "Other duties as assigned" after J&J Credo line. Then "Requirements" section: list of requirements. Then after that there is "Additional Information" about compensation, bonus, benefits, time off. Then "Required Skills Preferred Skills:" list. We need to map to sections. Let's decide: - About the role: include company mission paragraph, maybe the Credo paragraph, location, job title, brief overview. - Responsibilities: Essential Job Functions list. - Requirements: the bullet list under "Requirements" (Bachelor's..., etc.) - Qualifications: maybe we could treat "Requirements" as qualifications; but we have both Requirements and Qualifications as possible headings. The posting has "Requirements" heading; we could use that as Qualifications? But we need to follow instruction: Use headings e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. So we can have both Requirements and Qualifications if content distinct. However the posting only has one "Requirements" block; we could treat that as Requirements, and Qualifications could be empty -> we should not include Qualifications if no specific content. So we omit Qualifications. - Skills: the "Required Skills Preferred Skills:" list. - Benefits: the Additional Information about benefits (medical, dental, etc., retirement, time off). Also mention of bonus. - Pay: the anticipated base pay range. - Schedule: none -> omit. We must not include duplicated lines. There's duplicate "Employee may be required to lift objects up to 25lbs." appears twice; we should include only once. Also duplicate "Must be able to communicate effectively..." etc. We need to ensure we preserve all substantive info, but we can deduplicate identical lines. Now craft HTML. We'll start with a

  for metadata maybe: location, job function etc. But we can incorporate into About the role. Let's draft:

  About the role

  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. As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

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

  The Sr. Design Quality Engineer (Embedded Software and Hardware System Verification & Validation) works closely and partners with internal departments to efficiently deliver safe and effective medical device designs for manufacturing, which are in line with Shockwave Medical Inc. (SWMI) policies and procedures. This position will represent Quality Design Engineering Assurance for hardware and embedded software design, development, design system verification and validation and support sustaining engineering to drive improvements with respect to hardware, software, and equipment. This includes supporting project teams to ensure that new and existing products are designed and developed in accordance with customer, corporate, and regulatory guidelines as well as working closely with Design and Manufacturing Engineering to improve processes where possible. Provides Quality Assurance support to functions with a focus on process improvements 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.

  Now Responsibilities: list essential job functions. We need to extract each bullet from "Essential Job Functions". Let's list them: - Ensures new Design projects and Design Change activities are performed in compliance with medical device regulations, standards, and internal procedures. - Participates in Design reviews to document and ensure that the design meets the intended customer requirements. - Develops/Reviews/Performs Embedded Software and Hardware System Design Verification and Validation Test Plan, Test Protocols, and Reports. - Is a Subject Matter Expert on application of relevant standards, usage of statistical techniques for new Design and Development Projects. - Responsible for Risk Management files documents such as Risk Management Plan, Risk Analysis, Failure Mode and Effects Analysis (FMEA), Risk Management Reports. - Develops device Quality and System V&V Plans to ensure that the elements of the Quality Management System is appropriately described and managed. - Provides Software level of concern and classification of Software modules. - Audits DHFs to ensure compliance with the Design Control procedure. - Assists in qualifying molds, fixtures, tooling, and equipment. - Perform/support process validations, identify, drive, and implement process improvements. - Supports ongoing Regulatory submission activities and product approval processes. - Identifies testing and analysis required to ensure conformance to product specifications. - Supports hardware scalability and continuous improvement projects - Initiates, reviews, and approves Document Change Orders (DCO.) - Provides support for Manufacturing and Operations. - Works with contract manufacturers to maintain product quality and resolve any non-conformances that arise. - Performs or assists in root cause analysis of product non-conformances found in manufacturing. - Evaluates/investigates and documents investigation results for returned devices from clinical studies and commercial complaints. - Reviews, investigates, dispositions, and drives to completion Non-conforming Reports (NCR) and Corrective and Preventive Actions (CAPA.) - Analyzes and reviews data for key Quality metrics to identify any significant trends. - Drives Standard Gap Assessment activities. - Participates in internal, supplier and third-party audits (FDA, FDB, Notified Body, etc.) - Participates in the implementation and continuous improvement of the Quality Management System. - Provides technical support to the Quality inspection group. - Recommends QC sampling plans based on desired confidence and reliability limits. - Participates in Supplier Quality activities including material non-conformances and Supplier audits. - J&J Credo: Understands and applies Johnson & Johnson’s Credo and Leadership Imperatives in day-to-day interactions with team. - Other duties as assigned We need to include all these as
• . Ensure no duplication. Now Requirements: The block after "Requirements". Let's extract: - Bachelor’s in software/electrical engineering with 5+ years of hands-on experience with Embedded Software, Hardware Design and Development. - System of System Design Verification and Validation Testing in the Medical Device industry or an MS with 3+ years of hands-on experience with Embedded Software, Hardware Design and Development, System of System Design Verification and Validation Testing in the Medical Device industry. - Working knowledge of applicable medical device regulations and standard such as ISO 13485, ISO 14971, IEC 62304, IEC 62366, IEC 60601, 21 CFR Part 820, MDD 93/42/EEC, EU MDR, and MDSAP required. - Experience with Analog and Digital Circuit Design, schematic layouts, PCB.Layout/ design, prototype development, automation tests, server component validation, stress, and reliability tests. - Experience with design and development of embedded systems, Source version control, Issue Tracking, power, and control electronics for use in medical devices and programming experience is highly desired. - Responsible for design component and assembly documentation for new products being developed - Class III medical device experience and electromechanical device product - Ability to perform multiple tasks concurrently with accuracy.