Jobs · Engineering · North Carolina

Transfer Engineer I-II

Aptyx · Charlotte, NC · 1 mo ago
EngineeringFull-time
We need to output HTML fragment with sections only if content present. Use

for headings: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. We must not repeat job title. We need to parse the posting. The posting includes: - Intro paragraph: "The Transfer Engineer I–II plays a key role..." That's about the role. - Duties And Responsibilities: long list. - Qualifications: includes background, education, experience levels. - Skills, Knowledge, And Abilities: list. - Competencies: list of competency descriptions. - Measurement of Performance: list. - Physical Demands of Position: description. We need to decide which sections to include. The instructions: include a section ONLY when posting has real, specific content for it — never emit heading followed by filler/placeholder text. So we need to map content to headings. Potential sections: - About the role: we have intro paragraph. - Responsibilities: we have Duties And Responsibilities. - Requirements: maybe combine Qualifications? But they have separate Qualifications and Skills sections. The instruction list includes Requirements as a possible heading. Could use Requirements for qualifications (education, experience). Could also have Skills for skills list. - Benefits: not present; no mention of benefits, pay, schedule. So we should NOT include Benefits, Pay, Schedule sections. - Qualifications: we have Qualifications section. - Skills: we have Skills, Knowledge, And Abilities. We also have Competencies and Measurement of Performance and Physical Demands. Those could be placed under maybe Responsibilities? But they are separate sections. The instruction only lists specific headings; we cannot create new headings like Competencies. So we must fit content into allowed headings. If content doesn't fit, maybe we omit? But we must preserve ALL substantive information; cannot invent or summarize away detail. However we cannot create new headings beyond the list. We could embed those details under existing headings like Responsibilities or Skills, but must preserve info. The instruction: "Use

for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule)." It says e.g., implying those are examples but we should use those headings. Likely we should only use those headings. So we need to map all content into those sections. We have: - About the role: intro paragraph. - Responsibilities: Duties And Responsibilities (including all duty bullet points). Also maybe include Competencies? But competencies are more about expectations; could be part of Responsibilities or Requirements. We'll include them under Responsibilities as they describe expected behaviors. - Requirements: could include Qualifications (education, experience) and maybe Skills? But Skills is separate heading. We'll put education/experience under Requirements. - Qualifications: maybe we could treat Qualifications as same as Requirements? But they are separate headings; we have both Qualifications and Requirements in the list. We could use Qualifications for education/experience, and Requirements for skills? However the list includes both; we need to decide. Better: Use Qualifications for education/experience, Requirements for skills/knowledge/abilities. But the posting has a "Skills, Knowledge, And Abilities" section. That maps to Skills heading. Thus: - About the role: intro. - Responsibilities: Duties And Responsibilities + Competencies + Measurement of Performance + Physical Demands? Might be too much but we can include. - Requirements: maybe we can put nothing? But we need to include something. Could put "Background in disposable medical device design..." etc. That's qualifications. Actually the posting has a "Qualifications" heading with background, education, experience. So we can map that to Qualifications heading. - Skills: map to Skills, Knowledge, And Abilities. Thus we have sections: About the role, Responsibilities, Qualifications, Skills. We must not include Benefits, Pay, Schedule. Now we need to format lists with
  • . For prose, use

    . We need to preserve all substantive information. So we need to include all bullet points from Duties And Responsibilities, Competencies, Measurement of Performance, Physical Demands. We need to ensure we don't lose any detail. Let's extract content. Intro paragraph: "The Transfer Engineer I–II plays a key role in supporting and leading the transfer of interventional and transcatheter medical devices from development into production. This position contributes to Aptyx's end-to-end solutions for Class II and III medical devices, including implants, catheters, and other disposable products. This role spans early-career to mid-level engineering capability, with increasing responsibility for process development, validation, equipment implementation, and customer engagement. The Transfer Engineer will work cross-functionally with Operations, Quality, Supply Chain, and customers to deliver robust, scalable, and cost-effective manufacturing processes." That's about the role. Now Duties And Responsibilities: It has subheadings: Quality System & Compliance, Process Development & Manufacturing Transfer Support (Level I) and lead (Level II) hands-on process development..., Validation & Risk Management, Production Support & Continuous Improvement, Design for Manufacturability (DFM), Supplier & Material Management, Customer & Cross-Functional Collaboration, Documentation & Systems, Project Execution Support. We need to preserve all bullet points under each. Let's extract each bullet. Quality System & Compliance: - Follow the Aptyx Quality System and all applicable SOPs within the Training Matrix. - Ensure compliance with medical device regulations and internal validation standards. Process Development & Manufacturing Transfer Support (Level I) and lead (Level II) hands-on process development of catheters, implants, and disposable medical devices. - Assist (I) or independently develop (II) pilot and manufacturing equipment, processes, and procedures. - Support (I) and lead (II) equipment acquisition, setup, and installation qualification (IQ). - Execute design changes and support product line transfers into production. Validation & Risk Management: - Contribute to (I) and independently plan/execute (II) validation activities including IQ, OQ, PQ, TMV, Gage R&R, and MSA. - Support (I) and lead (II) development and maintenance of pFMEAs and Master Validation Plans (MVPs). - Ensure validation documentation is accurate, complete, and audit-ready. Production Support & Continuous Improvement: - Support production builds, line setup, troubleshooting, and training activities. - Lead (II) or contribute (I) to Lean and Six Sigma initiatives to reduce waste and improve efficiency. - Conduct time studies, capacity analysis, and layout optimization to improve throughput. - Analyze COGS and identify cost-reduction opportunities. Design for Manufacturability (DFM): - Participate in (I) and lead (II) DFM discussions with R&D. - Recommend design improvements to enhance manufacturability, yield, and cost. Supplier & Material Management: - Coordinate with suppliers on material specifications, validations, and quality issues. - Support (I) or lead (II) supplier validations and material change processes. Customer & Cross-Functional Collaboration: - Communicate project status, risks, and technical updates to customers. - Escalate issues appropriately (I) or independently manage customer communication (II). - Collaborate with cross-functional teams including Operations, Quality, and Supply Chain. Documentation & Systems: - Review and update manufacturing documentation (work instructions, BOMs, routings). - Maintain ERP data and engineering change orders. - Write and review test methods and validation protocols. Project Execution Support (I) or lead (II) project execution, ensuring alignment to timelines, scope, and budget. - Demonstrate increasing ownership and decision-making responsibility at Level II. Now Competencies section: It lists several competency areas with Level I and Level II descriptions. We need to preserve all. Competencies: Technical & Engineering Excellence Level I: Applies foundational engineering principles; executes tasks with guidance Level II: Independently develops processes and solves complex technical problems Validation & Quality Mindset Level I: Supports validation execution and documentation Level II: Leads validation strategy and ensures compliance and robustness Project Ownership & Execution Level I: Contributes to project tasks and meets assigned deadlines Level II: Owns project deliverables, timelines, and execution with minimal oversight Continuous Improvement & Lean Thinking Level I: Identifies inefficiencies and supports improvement initiatives Level II: Leads Lean projects and drives measurable operational improvements Collaboration & Communication Level I: Communicates effectively within team; escalates issues appropriately Level II: Independently interfaces with customers and leads cross-functional alignment Business & Cost Acumen Level I: Understands basic cost drivers and supports cost tracking Level II: Analyzes COGS and implements cost reduction strategies Problem Solving & Decision Making Level I: Uses structured problem-solving with guidance Level II: Leads root cause analysis and implements sustainable corrective actions Measurement of Performance: - Execution of projects on time and within scope - Quality and compliance of validation and engineering documentation - Contribution to process improvements and cost savings - Effectiveness in cross-functional collaboration and communication - Customer satisfaction and responsiveness - Demonstrated growth in technical capability and ownership Physical Demands of Position: - The physical demands described are representative of those required to successfully perform the essential functions of this role. Reasonable accommodations may be made. - This position requires sitting, standing, and use of hands for computer and laboratory tasks. - The role operates in both laboratory and manufacturing environments with variable conditions. - Effective communication (verbal and written) and standard vision/hearing capabilities are required. Now Qualifications section: Qualifications: - Background in disposable medical device design, development, and manufacturing. - Knowledge of materials, prototyping, and manufacturing processes. - Project management experience preferred (increasing expectation at Level II). - Education Bachelor's or Master's degree in Biomedical Engineering, Mechanical Engineering, or related field required. - Experience Level I: 1+ years of relevant engineering experience (medical device preferred) - Level II: 2–5 years of experience in medical device engineering or manufacturing - Experience with SolidWorks or equivalent CAD software preferred. Skills, Knowledge, And Abilities: - Proficiency in MS Office, CAD (SolidWorks), and ERP systems - Understanding of medical device regulations and validation methodologies - Strong analytical and problem-solving skills - Effective communication and collaboration skills - Ability to manage multiple priorities in a fast-paced environment - Experience with Lean Manufacturing and Six Sigma tools (preferred for Level II) Now we need to output HTML fragment. We'll have:

    About the role

    ...intro...

    Responsibilities

    • ...list all duty bullets...
    • ... also include competencies? Could embed as list items under responsibilities. But we have many items; we can just put all duty bullets and then also include competencies as list items? Might be okay. But we need to preserve all substantive info; we can include them as list items under responsibilities. Similarly, we could include Measurement of Performance and Physical Demands as list items under responsibilities as well. But that may be mixing categories; but still preserving. Alternatively, we could create separate sections for Competencies, Measurement of Performance, Physical Demands but those headings are not in allowed list. So we must embed. Thus responsibilities will be a long list. Now Qualifications section:

      Qualifications

      • Background in disposable medical device design, development, and manufacturing.
      • Knowledge of materials, prototyping, and manufacturing processes.
      • Project management experience preferred (increasing expectation at Level II).
      • Education: Bachelor's or Master's degree in Biomedical Engineering, Mechanical Engineering, or related field required.
      • Experience Level I: 1+ years of relevant engineering experience (medical device preferred)
      • Level II: 2–5 years of experience in medical device engineering or manufacturing
      • Experience with SolidWorks or equivalent CAD software preferred.
      Skills section:

      Skills

      • Proficiency in MS Office, CAD (SolidWorks), and ERP systems
      • Understanding of medical device regulations and validation methodologies

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