Full-Time

Senior Manufacturing Engineer

Shockwave

Posted on 5/9/2026

Johnson & Johnson

Johnson & Johnson

10,001+ employees

Global healthcare company offering pharma, devices.

Compensation Overview

$89k - $142.6k/yr

+ Bonus

Santa Clara, CA, USA

In Person

Must be able to travel internationally.

Category
Mechanical Engineering (1)
Required Skills
Data Analysis
SolidWorks
Requirements
  • Bachelor’s degree on Mechanical Engineering or related field
  • 5 years of experience in all phases of Process/Manufacturing development to launch for high volume commercial or medical devices and transfer of product lines externally
  • Strong problem solving and analytical skills; experience with use of statistical analysis and design of experiments for product optimization and validation activities
  • Excellent organizational, verbal, and written communication skills as well as attention to detail
  • Experience with lean manufacturing, design for manufacturability and test implementation
  • Experience with balloon/stent catheter manufacturing
  • Experience with braiding, coiling & laser processing operations a plus
  • Proficient with SolidWorks a plus
  • Able to interface with all levels and functions of the organization; requires a cooperative team-balanced perspective for appropriate output and task outcome
  • Experience working in regulated product and manufacturing environments (ISO, FDA, cGMP)
  • Knowledge of and compliance with applicable Quality System requirements (e.g., traceability QSRs, ISO and MDD requirements.) and other applicable regulations
  • Experience in Program Management, use of Gantt Charts or Smartsheet
  • Proficiency in Statistics (Cpk, Hypothesis Testing, DOE, Gage R&R) a plus
  • Must be able to lift objects up to 25lbs
  • Must be able to travel abroad to oversee the implementation process and the qualification-validation efforts
Responsibilities
  • Acts as the primary technical point of contact; works with our contract manufacturer and external partner to transfer and scale Shockwave manufacturing process
  • Supports development transfer activities from R&D & Operations to contract manufacturer/suppliers
  • Works with local, international suppliers and manufacturing sites to generate capacity/capability models and make vs. buy assessments used as an input to site planning
  • Responsible for preparation and execution of validation protocols and completion of validation reports
  • Develops and maintains process risk documentation (e.g., PFMEA) to identify potential risks and implement preventive and corrective actions
  • Prepares engineering change orders and coordinates the implementation of changes including training production staff
  • Provides expertise in project planning and timeline development & management and maintain project schedules and timelines
  • Implements and manage process improvement and cost reduction projects
  • Ensures capacity is appropriate for the manufacturing plan
  • Effectively utilizes lean manufacturing tools for continuously improving the flow of material and information in the factory including factory layouts, visual management, 6S, JIT, Kanban
  • Implement robust cost-effective manufacturing processes and improve product flow and product quality and safety performance for both sustained and new products
  • Collaborates with cross-functional teams during development phase(s) and provides inputs and recommendations for design for manufacturability (DFM)
  • Develops, tests, and implements tools, fixtures and equipment required for manufacturing processes
  • Support improvements for mechanical equipment features like 3D Printing, UL Impact testing, and Material selection
  • Develops manufacturing process instructions, inspection plans and lot history travelers
  • Performs analysis for cost reduction, and quality and efficiency improvement
  • Leads design transfer of new products to production including establishing assembly time and yield targets, training needs and quality control
  • Assists suppliers in product failure investigations required to determine root cause, improve product reliability, performance improvement as well as effective containment and counter measures
  • Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements (ISO), Company policies, operating procedures, processes, and task assignments
  • Performs other responsibilities and duties as assigned
Desired Qualifications
  • Proficiency in SolidWorks
  • Other desirable items not explicitly described

Johnson & Johnson operates in three main areas—pharmaceuticals, medical devices, and consumer health products—serving consumers, healthcare professionals, and institutions worldwide. It develops prescription medicines, sells surgical and vision care devices, and offers over-the-counter and personal care products, funded by direct sales, partnerships, and distribution agreements, with heavy investment in research and development. The company differentiates itself by combining three complementary businesses under one umbrella and maintaining a global footprint with an emphasis on science, innovation, and inclusive culture. Its goal is to help people live healthier lives by delivering reliable, high-quality healthcare products and solutions that improve patient outcomes.

Company Size

10,001+

Company Stage

IPO

Headquarters

New Brunswick, New Jersey

Founded

1886

Simplify Jobs

Simplify's Take

What believers are saying

  • Icotyde launches with 1,500 prescriptions, Guggenheim projects $14.9 billion peak sales.
  • Atraverse Medical acquisition bolsters HOTWIRE system for atrial fibrillation ablations.
  • ETHICON 4000 Stapler gains CE Mark, reducing surgical leaks costing €5,200 per case.

What critics are saying

  • Stelara sales plummet 60% to $656 million from Amgen and Samsung biosimilars.
  • Over 90,000 talc lawsuits trigger $966 million October 2025 verdict against J&J.
  • CARVYKTI manufacturing shortfalls cap multiple myeloma sales growth in 2026.

What makes Johnson & Johnson unique

  • Diversified revenue spans Innovative Medicine, MedTech, and consumer health segments.
  • DARZALEX sales hit $4 billion in Q1 2026, exceeding forecasts by $600 million.
  • CARTO System marks 30 years, powering AI-driven CARTOSOUND SONATA for electrophysiology.

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Benefits

Health Insurance

Dental Insurance

Vision Insurance

Life Insurance

Disability Insurance

401(k) Retirement Plan

401(k) Company Match

Paid Vacation

Paid Sick Leave

Paid Holidays

Remote Work Options

Performance Bonus

Company News

Yahoo Finance
Apr 14th, 2026
J&J's Spravato hits $468M in Q1 sales, signalling upside for psychedelics peers like Atai

Johnson & Johnson's Spravato reported $468 million in first-quarter 2026 sales, up 46% year over year, signalling potential for psychedelics-focused companies like AtaiBeckley Inc., according to Jefferies analysts. The esketamine nasal spray, approved for treatment-resistant depression, is on track to reach an annualised run rate exceeding $1.9 billion. Jefferies maintained that Spravato could hit $3 billion in annual sales by 2027 and $5 billion at peak. Over 200,000 patients have been treated globally, up from 140,000 at the start of 2025. Analysts said Spravato's commercial success demonstrates psychedelics can succeed in mainstream healthcare, with existing treatment infrastructure potentially easing adoption of emerging therapies. They highlighted ATAI's intranasal candidate BPL-003 as fitting seamlessly into Spravato's treatment paradigm.

Yahoo Finance
Apr 14th, 2026
J&J hits $100B milestone with 6.4% growth, eyes double-digit revenue by decade's end

Johnson & Johnson reported 6.4% operational sales growth in Q1 2026, raising full-year guidance to $100.2 billion — the first time the company has reached the $100 billion milestone. The company reaffirmed expectations for double-digit revenue growth by decade's end. Innovative Medicine grew 7.4%, driven by 10 double-digit growing brands including DARZALEX and TREMFYA, despite a 61.7% decline in STELARA due to biosimilar competition. MedTech posted 4.6% growth, led by heart recovery and electrophysiology divisions. The company successfully launched ICOTYDE, the first oral IL-23 peptide for immunology. Management is progressing a $55 billion US manufacturing and R&D investment through 2029, with $12 billion already deployed. The planned separation of its DePuy Synthes Orthopaedics business targets mid-2027 completion.

Business Wire
Apr 7th, 2026
Johnson & Johnson launches VARIPULSE Pro in Europe with 5x faster ablation for atrial fibrillation treatment

Johnson & Johnson has launched VARIPULSE Pro in Europe following CE Mark approval, advancing its pulsed field ablation portfolio for treating atrial fibrillation. The system features a new pulse sequence that operates five times faster than its predecessor whilst maintaining equivalent lesion quality. VARIPULSE Pro integrates with the CARTO 3 mapping system and offers a lower temperature profile whilst preserving the platform's established safety and effectiveness profiles. The company is conducting the VARIPURE multicentre study to generate clinical evidence during the commercial launch phase. The technology addresses atrial fibrillation, the most common cardiac arrhythmia affecting over 50 million people worldwide. Johnson & Johnson will showcase VARIPULSE Pro at the European Heart Rhythm Association annual meeting, with 12-month interim study results to be presented. The device is not currently approved in the United States.

Yahoo Finance
Apr 3rd, 2026
J&J's dividend stays resilient despite market sell-offs and healthcare challenges

Johnson & Johnson has raised $120 million in a Series C round led by Ribbit Capital, valuing the company at $1.45 billion. Sequoia and Kleiner Perkins participated, with Emerson Collective joining as a new backer. The pre-revenue company is developing "Mathematical Superintelligence", an AI system focused on advanced reasoning that claims to eliminate hallucinations by requiring outputs in Lean4 programming language. Its flagship model, Aristotle, achieved top-level performance at the International Mathematical Olympiad in July. Founded in 2023, Harmonic has raised $295 million across three funding rounds in 14 months. The company currently offers Aristotle via a free API and plans to commercialise in safety-critical industries like aerospace and finance.

Yahoo Finance
Apr 1st, 2026
J&J takes over NBTXR3 Phase III as Nanobiotix shifts to Curadigm, secures runway into early 2028

Nanobiotix has transferred full operational and financial responsibility for its NBTXR3 radioenhancer programme to Johnson & Johnson, with Phase III head-and-neck results expected in H1 2027 and Phase II lung cancer data anticipated in early 2027. The company is pivoting towards its Curadigm nanoprimer platform, filing four patents, starting GMP manufacturing and signing over 20 material transfer agreements with partners. Additional Curadigm data is expected before summer's end. An amended Janssen licence removing most Phase III funding obligations, combined with a royalty financing of up to $71 million, extends Nanobiotix's cash runway into early 2028. The company reported EUR 32.6 million revenue in 2025, reduced R&D spending to EUR 23.1 million, and EUR 52.8 million cash at year-end.