R&D Engineer Associate Level - Level II
Aptyx · Charlotte, NC · 1 mo ago
EngineeringFull-time
We need to output HTML fragment with headings for sections: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. Only include sections if posting has real specific content. The posting includes: description (About the role), Key Responsibilities (list), Education, Experience, Skills & Qualifications (list), Physical Requirements, Performance Expectations. There's no explicit Benefits, Pay, Schedule. So we should not include those sections. Also we should not repeat job title. We need to include sections: About the role (maybe from first paragraph), Responsibilities (list), Requirements (maybe Education + Experience?), Qualifications (maybe Skills & Qualifications?), Skills (maybe separate?), but we need to follow headings list: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. We can combine some. The posting has Education, Experience, Skills & Qualifications, Physical Requirements, Performance Expectations. We could map: Requirements = Education + Experience. Qualifications = Skills & Qualifications (maybe plus Physical Requirements?). Skills = maybe separate list of skills? But we already have Skills & Qualifications. To avoid duplication, we can treat Skills & Qualifications as Skills section. Qualifications could be Education+Experience? But we need to avoid thin sections. Let's think: The posting includes:
- About the role: first paragraph(s) describing role.
- Responsibilities: bullet list under Key Responsibilities (multiple subcategories).
- Requirements: Education and Experience.
- Qualifications: Skills & Qualifications (list).
- Skills: maybe we could split out specific skills from Skills & Qualifications? But that would be thin. Better to combine Skills & Qualifications into Skills section and omit Qualifications? But we need to follow instruction: include a section ONLY when posting has real, specific content for it. So we can decide which headings to include based on content. We have content for About the role, Responsibilities, Requirements (Education+Experience), Skills (Skills & Qualifications). Also we have Physical Requirements and Performance Expectations; those could be part of Requirements or Qualifications? Could be separate but not in heading list. Since only allowed headings are those listed, we must fit content into those headings. Physical Requirements and Performance Expectations could go under Requirements or Qualifications. Probably under Requirements (as they are requirements). But we already have Education+Experience; we could add Physical Requirements under Requirements as a sublist. Performance Expectations could go under Qualifications? Or maybe under Skills? But better to put under Requirements as well.
Thus sections:
items preserving text. The responsibilities are grouped under subheadings: Product Design & Development, Manufacturing & Process Development, Validation, Testing & Documentation, Project Support & Communication, Vendor & Cross-Functional Collaboration. We could keep those as part of list items or maybe as subheadings? But only allowed headings are the specified ones; we cannot add extra headings like or maybe as inside . That's acceptable.
Similarly for Skills & Qualifications: list items.
For Requirements: we need Education and Experience and Physical Requirements and Performance Expectations. Could be a list.
We must not include boilerplate like EEO etc. There's none.
We must not include job ID etc.
We must not include application instructions.
We must not include duplicated lines.
We need to output only HTML fragment.
Let's extract the content.
First paragraph(s) about role:
"The R&D Engineer II performs design engineering functions in support of medical device product development programs across multiple therapeutic areas including cardiology, neurology, and urology. This role contributes to projects from concept through commercialization, ensuring deliverables meet customer requirements for quality, cost, and schedule performance. The Engineer II works with moderate independence to execute engineering tasks, support project deliverables assigned by the Project Manager, and communicate technical status updates to cross-functional teams. Updates may include technical feasibility, schedule impact, budget considerations, and risk to project objectives. This role also supports development of engineering processes, manufacturing readiness, and continuous improvement of product and design solutions within a regulated environment."
That's the about role.
Now Responsibilities: Under "Key Responsibilities" we have sections with bullet points.
Let's capture each bullet:
Product Design & Development
- Follow the Aptyx Quality System, including all applicable SOPs and training requirements
- Develop and engineer medical devices from concept through production with little supervision
- Perform hands-on product assembly and process development for catheters and other medical devices
- Design devices, components, tooling, and fixtures using SolidWorks or equivalent CAD software
- Build prototypes and support laboratory-based development activities
- Engage with senior and principal engineers for technical guidance as needed
Manufacturing & Process Development
- Design and develop pilot and production tooling, fixtures, equipment, and manufacturing procedures with limited supervision
- Support installation, setup, and qualification of new equipment, including development of preventive maintenance (PM) procedures as needed
- Perform or support equipment maintenance and coordinate re-entry to production use, escalating issues to the Technology Manager when appropriate
- Assess process feasibility and support manufacturing with validation planning and time studies
- Develop manufacturing methods and support product transition into full production
Validation, Testing & Documentation
- Develop and execute verification and validation activities with limited supervision, including testing and documentation
- Prepare engineering documentation to support the quality system, including:
- Test results and data analysis
- Engineering drawings
- Test reports
- Ensure compliance with good documentation practices and regulatory requirements
- Support engineering changes and updates to existing product lines as needed
Project Support & Communication
- Communicate directly with project teams and leadership regarding task status, risks, and technical challenges
- Support execution of project deliverables assigned by the Project Manager
- Provide input on technical feasibility, schedule, and budget impacts
- Demonstrate understanding of the design and development (D&D) process through execution of assigned work
- Support manufacturing and product development activities through commercialization
Vendor & Cross-Functional Collaboration
- Collaborate with external vendors on sourcing of materials, components, tooling, and manufacturing processes
- Support engineering teams in investigations related to customer complaints and product issues
- Work cross-functionally with Quality, Manufacturing, Supply Chain, and Project Management teams
Now Requirements: Education, Experience, Physical Requirements, Performance Expectations.
Education: "Bachelor's or Master's degree in Biomedical Engineering, Mechanical Engineering, or related discipline required"
Experience: "3+ years of engineering experience in medical device development or regulated manufacturing environment. Experience with catheter-based or complex medical device development strongly preferred"
Physical Requirements: list:
- Ability to work in both laboratory and manufacturing environments with variable conditions
- Frequent use of hands, arms, and fingers for engineering and technical tasks
- Ability to sit, stand, and move throughout production and lab environments
- Normal vision and hearing required for communication and technical work
- Must be able to effectively communicate in person, electronically, and via phone
Performance Expectations:
- Adherence to the Aptyx Quality System and SOP compliance requirements
- Timely and accurate completion of engineering deliverables and documentation
- Clear and proactive communication of task status, risks, and technical issues
- Consistent on-time and on-budget execution of assigned work
- Proficiency in SolidWorks and adherence to internal drawing/documentation standards
- Demonstrated understanding of multiple medical device manufacturing technologies (e.g., bonding, fixture design, PTFE processing, etc.)
- Strong understanding of the design and development (D&D) process and its impact on project execution
- Demonstrated growth in technical capability, independence, and problem-solving ability
Now Skills & Qualifications: list:
- Proficiency in SolidWorks or equivalent CAD software
- Strong experience in hands-on prototyping and mechanical assembly
- Knowledge of medical device materials and manufacturing processes (e.g., thermal bonding, PTFE processing, fixture design, etc.)
- Familiarity with validation (IQ/OQ/PQ), design controls, and regulated product development processes
- Strong analytical and problem-solving skills
- Excellent verbal and written communication skills
- Proficiency in Microsoft Office Suite
- Ability to use basic hand tools (drills, screwdrivers, wrenches, saws, etc.)
- Familiarity with multiple manufacturing methods used in device production
We could treat this as Skills section.
Now we need to output HTML with sections.
We'll include:
for sections: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. Only include sections if posting has real specific content. The posting includes: description (About the role), Key Responsibilities (list), Education, Experience, Skills & Qualifications (list), Physical Requirements, Performance Expectations. There's no explicit Benefits, Pay, Schedule. So we should not include those sections. Also we should not repeat job title. We need to include sections: About the role (maybe from first paragraph), Responsibilities (list), Requirements (maybe Education + Experience?), Qualifications (maybe Skills & Qualifications?), Skills (maybe separate?), but we need to follow headings list: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. We can combine some. The posting has Education, Experience, Skills & Qualifications, Physical Requirements, Performance Expectations. We could map: Requirements = Education + Experience. Qualifications = Skills & Qualifications (maybe plus Physical Requirements?). Skills = maybe separate list of skills? But we already have Skills & Qualifications. To avoid duplication, we can treat Skills & Qualifications as Skills section. Qualifications could be Education+Experience? But we need to avoid thin sections. Let's think: The posting includes:
- About the role: first paragraph(s) describing role.
- Responsibilities: bullet list under Key Responsibilities (multiple subcategories).
- Requirements: Education and Experience.
- Qualifications: Skills & Qualifications (list).
- Skills: maybe we could split out specific skills from Skills & Qualifications? But that would be thin. Better to combine Skills & Qualifications into Skills section and omit Qualifications? But we need to follow instruction: include a section ONLY when posting has real, specific content for it. So we can decide which headings to include based on content. We have content for About the role, Responsibilities, Requirements (Education+Experience), Skills (Skills & Qualifications). Also we have Physical Requirements and Performance Expectations; those could be part of Requirements or Qualifications? Could be separate but not in heading list. Since only allowed headings are those listed, we must fit content into those headings. Physical Requirements and Performance Expectations could go under Requirements or Qualifications. Probably under Requirements (as they are requirements). But we already have Education+Experience; we could add Physical Requirements under Requirements as a sublist. Performance Expectations could go under Qualifications? Or maybe under Skills? But better to put under Requirements as well.
Thus sections:
About the role
... (the descriptive paragraph(s))...
Responsibilities
- ... list items ...
. So we should embed those subheadings as plain text within
About the role
...
Responsibilities
- ...
Requirements
- ...
Skills
- ...
About the role
The R&D Engineer II performs design engineering functions in support of medical device product development programs across multiple therapeutic areas including cardiology, neurology, and urology. This role contributes to projects from concept through commercialization, ensuring deliverables meet customer requirements for quality, cost, and schedule performance. The Engineer II works with moderate independence to execute engineering tasks, support project deliverables assigned by the Project Manager, and communicate technical status updates to cross-functional teams. Updates may include technical feasibility, schedule impact, budget considerations, and risk to project objectives. This role also supports development of engineering processes, manufacturing readiness, and continuous improvement of product and design solutions within a regulated environment.
Responsibilities
- Follow the Aptyx Quality System, including all applicable SOPs and training requirements
- Develop and engineer medical devices from concept through production with little supervision
- Perform hands-on product assembly and process development for catheters and other medical devices
- Design devices, components, tooling, and fixtures using SolidWorks or equivalent CAD software
- Build prototypes and support laboratory-based development activities
- Engage with senior and principal engineers for technical guidance as needed
- Design and develop pilot and production tooling, fixtures, equipment, and manufacturing procedures with limited supervision
- Support installation, setup, and qualification of new equipment, including development of preventive maintenance (PM) procedures as needed
- Perform or support equipment maintenance and coordinate re-entry to production use, escalating issues to the Technology Manager when appropriate
- Assess process feasibility and support manufacturing with validation planning and time studies
- Develop manufacturing methods and support product transition into full production
- Develop and execute verification and validation activities with limited supervision, including testing and documentation
- Prepare engineering documentation to support the quality system, including:
- Test results and data analysis
- Engineering drawings
- Test reports
- Ensure compliance with good documentation practices and regulatory requirements
- Support engineering changes and updates to existing product lines as needed
- Communicate directly with project teams and leadership regarding task status, risks, and technical challenges
- Support execution of project deliverables assigned by the Project Manager
- Provide input on technical feasibility, schedule, and budget impacts
- Demonstrate understanding of the design and development (D&D) process through execution of assigned work
- Support manufacturing and product development activities through commercialization
- Collaborate with external vendors on sourcing of materials, components, tooling, and manufacturing processes
- Support engineering teams in investigations related to customer complaints and product issues
- Work cross-functionally with