Catheter R&D Engineer

We need to output HTML fragment with sections: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. Only include sections if posting has real specific content. The posting includes description, duties, required qualifications, preferred qualifications, skills, physical demands, measurement of performance, acknowledgement. No explicit Benefits, Pay, Schedule. So we should not include those sections. Also we should not repeat job title. Use

for each section heading. Use

• for lists. Use

  for prose. We need to preserve all substantive information, remove boilerplate like EEO, etc. There's no explicit EEO but there is "Acknowledgement" etc. Should we keep that? It's part of job description but maybe considered boilerplate? It's not cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate, but it's an acknowledgement statement. Might be considered boilerplate but not explicitly listed. The instruction: Remove cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate, duplicated lines, and application instructions. Acknowledgement is not those, but could be considered legal? It's a statement about receiving job description. Might be considered legal boilerplate. Safer to remove it. Also "Physical Demands and Work Environment" and "Measurement of Performance" could be considered part of Responsibilities or Requirements? They are substantive. We could include them under a section like "Working Conditions" but not in allowed headings. Allowed headings are only those listed. We could incorporate that info into Responsibilities or Skills? Probably better to create a section "Responsibilities" includes duties, and maybe "Requirements" includes qualifications, and "Skills" includes skills. Physical demands and measurement of performance could be placed under "Responsibilities" as additional bullet points? Or we could create a section "Working Conditions" but not allowed. Since we must only use allowed headings, we need to fit content into those headings. The posting has: About the role (intro paragraph), Responsibilities (Duties And Responsibilities), Requirements (Required Qualifications), Qualifications (Preferred Qualifications), Skills (Skills, Knowledge, And Abilities). Also there is "Physical Demands and Work Environment" and "Measurement of Performance". Could be considered part of Responsibilities or maybe we could add a section "Working Conditions" but not allowed. Perhaps we can include them under Responsibilities as additional bullet points. Or we could create a section "Requirements" includes both required and preferred qualifications? But we have separate headings for Requirements and Qualifications. The instructions: Use

  for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). So we can have those headings. We need to decide what goes where. About the role: introductory paragraph describing role. Responsibilities: list of duties. Requirements: Required Qualifications. Qualifications: Preferred Qualifications. Skills: Skills, Knowledge, And Abilities. Physical Demands and Work Environment: maybe we could put under Responsibilities as additional bullet? Or maybe we could create a separate section but not allowed. Could we treat it as part of "Requirements"? Not really. Could we treat as part of "Skills"? Not really. Could we omit? The instruction: Preserve ALL substantive information; do NOT invent or summarize away detail. So we must include physical demands and measurement of performance somewhere. Since we cannot create new headings, we must embed them within allowed sections. Perhaps we can add a subsection within Responsibilities as a bullet list for "Physical Demands and Work Environment" and another for "Measurement of Performance". That would preserve info. Thus output:

  About the role

  ...

  Responsibilities

  • ...
  ... plus maybe sub-bullets? We can just list each duty as
  • . For physical demands we can add
  • Physical Demands and Work Environment: ...
  and
  • Measurement of Performance: ...
  . But we need to preserve the bullet points inside those sections. Could we nest lists? Probably okay to just include as separate
  • with the content. Similarly for Skills. We must not include boilerplate like "Acknowledgement". Also remove duplicated lines. Let's extract content. Intro paragraph: "Aptyx is seeking a highly motivated Medical Device Engineer with strong experience in the design and development of complex catheter-based medical devices. This role is intended for candidates at the Engineer II through Senior Engineer level who are comfortable working hands-on, driving technical development activities, and contributing throughout the full product lifecycle from concept through commercialization. The ideal candidate will possess deep technical knowledge of catheter design, materials, and manufacturing processes, along with the ability to collaborate cross-functionally within a fast-paced medical device development environment. This position requires a strong balance of engineering fundamentals, hands-on prototyping capability, design control knowledge, and practical manufacturing understanding." That's About the role. Responsibilities: list from "Duties And Responsibilities" bullet points. Let's list them: - Participate in and/or lead the design and development of complex catheter-based medical devices and delivery systems - Develop innovative design concepts and translate product requirements into functional engineering solutions - Create detailed 3D CAD models, engineering drawings, assemblies, and technical specifications using SolidWorks or equivalent CAD platforms - Perform engineering analysis including tolerance stack-ups, material selection, mechanical characterization, and performance evaluations - Build, refine, and troubleshoot prototype devices through hands-on bench development and iterative testing - Lead or support design verification activities including DV planning, development of test methods, protocol generation, and execution of mechanical and simulated-use testing - Collaborate with Operations, Tooling, Quality, and Manufacturing Engineering teams to develop robust and scalable manufacturing processes - Support Design for Manufacturability (DFM) initiatives related to catheter assembly, braiding, bonding, thermoforming, laser processing, and other specialized manufacturing techniques - Prepare and maintain Design History File (DHF) documentation including design inputs, design outputs, risk management files, protocols, reports, and engineering change documentation - Translate user needs, physician feedback, and clinical requirements into actionable engineering design inputs and specifications - Participate in design reviews, technical discussions, and project planning activities to support program milestones and deliverables - Support root cause investigations, CAPA activities, and product/process improvement initiatives - Ensure compliance with applicable FDA regulations, ISO standards, and Aptyx Quality System requirements - Mentor junior engineers and provide technical guidance where applicable - Perform other duties as assigned in support of engineering and business objectives We should remove "Perform other duties as assigned..." maybe it's generic but it's substantive? It's a typical boilerplate but maybe keep. It's not duplicated. We'll keep. Now Required Qualifications: - Bachelor's or Master's degree in Biomedical Engineering, Mechanical Engineering, or related engineering discipline - Minimum of 3 years of medical device product development experience; 5+ years preferred - Strong experience in the design and development of complex catheter systems, including one or more of the following: - Multi-material composite catheter construction - Multi-lumen shaft design - Coil reinforcement structures - Torque transfer systems including braids and laser-cut hypotubes - Balloon integration and attachment methods - Strong understanding of catheter materials including hypotubes, nitinol, polymer shafts, braids, coils, adhesives, and bonding processes - Proficiency with 3D CAD software, preferably SolidWorks - Demonstrated hands-on experience building prototypes, performing mechanical testing, and interpreting performance data - Experience identifying and supporting appropriate catheter manufacturing processes and assembly methods - Working knowledge of design controls, risk management, ISO 14971, ISO 13485, and 21 CFR Part 820 - Familiarity with applicable medical device standards including ISO 10555, ISO 11070, ISO 5840, ISO 25539, and related standards - Strong analytical, problem-solving, and troubleshooting skills - Effective verbal and written technical communication skills Preferred Qualifications: - Experience with steerable or deflectable catheter systems - Experience with complex multilumen shaft constructions or devices incorporating imaging, ablation, or therapeutic technologies - Hands-on experience with catheter manufacturing processes including braiding, laser processing, bonding, reflow, tipping, and thermoforming - Experience developing devices for structural heart, cardiovascular, or aortic applications - Experience supporting transfer to manufacturing and production scale-up activities - Familiarity with statistical analysis tools and engineering test method development Skills, Knowledge, And Abilities: - Strong technical understanding of catheter design architecture and manufacturing methodologies - Ability to work independently while managing multiple development priorities and timelines - Strong documentation discipline and attention to detail within regulated environments - Ability to collaborate effectively within cross-functional teams including R&D, Quality, Manufacturing, Regulatory, and Program Management - Hands-on engineering mindset with strong troubleshooting and iterative development capability - Ability to communicate complex technical concepts clearly to both technical and non-technical audiences Physical Demands and Work Environment: - This position requires work within office, laboratory, manufacturing, and cleanroom environments. The employee must be able to: - Sit, stand, and move throughout engineering labs and manufacturing areas - Perform detailed hands-on prototype assembly and bench testing activities - Use hands and fingers for fine motor assembly and measurement tasks - Operate laboratory and test equipment safely and effectively - Lift and move materials and equipment within safe working limits - Communicate effectively both verbally and in writing - Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. Measurement of Performance: - Achievement of project milestones and technical deliverables within established timelines - Quality, completeness, and compliance of engineering and DHF documentation - Effectiveness of prototype development, testing, and technical problem solving - Contribution to successful product development and commercialization activities - Collaboration and responsiveness within cross-functional project teams - Compliance with regulatory, quality, and design control requirements - Contribution to process improvements, innovation, and technical excellence within the engineering organization We need to embed Physical Demands and Measurement of Performance somewhere. Perhaps under Responsibilities as additional bullet points. Thus Responsibilities list will include all duty bullets plus two extra bullets for Physical Demands and Measurement of Performance (each containing sub-bullets? Could embed as a paragraph inside the li). Simpler: make each as a
  • containing a
    for subpoints. That's okay. Now we need to output only HTML fragment, no markdown. Let's craft. We'll have:

    About the role

    ...

    Responsibilities

    • Participate in and/or lead the design and development of complex catheter-based medical devices and delivery systems
    ...
    • Physical Demands and Work Environment:
      • This position requires work within office, laboratory, manufacturing, and cleanroom environments. The employee must be able to:
      • Sit, stand, and move throughout engineering labs and manufacturing areas
      • Perform detailed hands-on prototype assembly and bench testing activities
      • Use hands and fingers for fine motor assembly and measurement tasks
      • Operate laboratory and test equipment safely and effectively
      • Lift and move materials and equipment within safe working limits
      • Communicate effectively both verbally and in writing
      • Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
    • Measurement of Performance:
      • Achievement of project milestones and technical deliverables within established timelines
      • Quality, completeness, and compliance of engineering and DHF documentation
      • Effectiveness of prototype development, testing, and technical problem solving
      • Contribution to successful product development and commercialization activities
      • Collaboration and responsiveness within cross-functional project teams