Quality Design & Development Engineer II

We need to output HTML fragment with sections: About us? The user says use

for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). They say do NOT repeat the job title as a heading. The posting includes "About us" and "Position Summary". We need to decide which sections to include based on content. We have: - About us: description of company. Could be "About the role"? Actually "About us" is about company, not role. The instruction says use headings like About the role, Responsibilities, etc. But we can adapt: maybe "About the role" corresponds to Position Summary. "About us" could be omitted? The instruction says include a section ONLY when posting has real, specific content for it. We have content for About us (company description). Should we include a heading? The allowed headings list includes "About the role". Not "About us". But we could still use

About the role

for Position Summary. For company description maybe we could put under a

without heading? Or we could treat as "About the company" but not in list. Probably better to include a short paragraph without heading, as they said do not repeat job title as heading, but didn't forbid other headings not in list. However they gave examples; we should follow them. Use headings for sections we have: Responsibilities, Requirements (maybe Must Have), Qualifications (maybe Good To Have), Skills, Benefits, Pay. Also maybe "About the role" for Position Summary. We need to avoid boilerplate like EEO etc. Remove those lines. We need to preserve all substantive information. Let's extract: About us: "For over three decades, Cirtec Medical has been a leading outsourcing partner for complex medical devices. We specialize in providing comprehensive solutions for Class II and III devices, from design and development to precision components and finished device assembly. Our expertise spans neuromodulation, implantable drug delivery, cardiac rhythm management, structural heart, mechanical circulatory support, and minimally invasive surgical systems. Our dedicated teams prioritize growth, innovation, and collaboration. We actively seek opportunities for improvement to enhance our support for clients. If you embrace a growth mindset and thrive on challenges, you may be a perfect fit for our team!" Position Summary: "The Quality Design & Development Engineer II is responsible for providing support to product development teams and sustaining manufacturing/operations teams. This individual will be expected to apply design control principles and techniques for medical devices. As a member of one or more cross functional teams, this individual will ensure products are designed and developed in accordance with applicable regulatory requirements, customer requirements, and company policy." Key Responsibilities: list bullet points. Let's extract responsibilities bullet points: - Perform Design Quality Engineering activities throughout the design, development, and production of medical devices to ensure compliance to company’s Design Control procedures and regulatory requirements (specifically FDA 21 CFR 820 and ISO 13485). - Demonstrated understanding and application of regulations and standards (specifically ISO 14971, 2017/745 EUMDR, IEC 60601, IEC 10993). - Create, review and/or approve technical Design Control documentation to facilitate design, development, and product verification testing of medical devices in collaboration with cross-functional engineering teams. - Create and execute Quality Plans for Product Design and Development projects. - Represent Quality Engineering in technical design and phase end reviews. - Develop and perform Design of Experiments (DOE). - Develop and validate test methods. - Develop sampling plans and acceptance criteria for product testing and inspection methods using appropriate statistical techniques. - Lead and/or participate in risk management activities, develop Risk Management Plans and Reports, perform Hazards Analysis and FMEAs (Failure Mode Effects Analysis) to evaluate and ensure product safety and functionality. - Conduct and/or support root cause investigations, develop and implement corrective and preventative actions for quality system and product related nonconformances. - Support quality system improvement initiatives and CAPA’s. - Responsible for the assessment of technical standards, labeling and technical file requirements. - Responsible for the assessment of component and system level specifications relative to customer needs and product performance specifications. - Perform requirement flow down analysis on critical to quality product performance specifications down to components and process. - Apply Design for Reliability and Manufacturability tools and techniques. - Support for multiple projects, balancing priorities, and resources to meet both project and management expectations. - Prepare reports required by the project or department management. - Lead and/or participate in reviews and communications with customers. Then "Must Have" qualifications: - Bachelor’s degree (STEM engineering discipline required) and 2 years of experience required; or a combination of education and relevant work experience. - Experience in an engineering environment with mechanical, tool design, and manufacturing processes (medical device preferred). - Knowledge of quality assurance and regulatory compliance including Quality System Standards and Regulations. - Knowledge of product development processes and methods. - Must be able to read, write and speak fluent English. "Good To Have": - Knowledge of systems engineering discipline, Technical Standards, Hazard Analysis and Failure Mode and Effects Analysis (FMEA), Qualification, Test Method, and Process Validation. - Knowledge in the application of risk management. - ASQ Certification preferred. Salary Range: 89,000 to 108,000 Benefits: list: Training and career development, Healthcare and well-being programs including medical, dental, vision, wellness and occupational health programs, Paid Time Off and 401(k) retirement savings with a company match. We should not include EEO etc. We need to output HTML fragment only. Structure:

About the role

Position Summary ...

Responsibilities

• ...
...

Requirements

maybe combine Must Have and Good To Have? Could separate into Requirements and Qualifications. The instruction list includes Requirements, Qualifications, Skills. We have Must Have (requirements) and Good To Have (qualifications/skills). We'll make:

Requirements

for Must Have items.

Qualifications

for Good To Have items. Skills maybe not separate; we could embed in Qualifications. Benefits:

Benefits

... Pay:

Pay

Salary Range: $89,000 to $108,000

We should not include Schedule as not present. We need to ensure we don't include filler like "commensurate with experience". Not present. We need to preserve all substantive information. Ensure we include all bullet points. Let's craft HTML. We need to escape any special characters? Not needed. We'll output:

About the role

The Quality Design & Development Engineer II is responsible for providing support to product development teams and sustaining manufacturing/operations teams. This individual will be expected to apply design control principles and techniques for medical devices. As a member of one or more cross functional teams, this individual will ensure products are designed and developed in accordance with applicable regulatory requirements, customer requirements, and company policy.

Responsibilities

• Perform Design Quality Engineering activities throughout the design, development, and production of medical devices to ensure compliance to company’s Design Control procedures and regulatory requirements (specifically FDA 21 CFR 820 and ISO 13485).
• Demonstrated understanding and application of regulations and standards (specifically ISO 14971, 2017/745 EUMDR, IEC 60601, IEC 10993).
• Create, review and/or approve technical Design Control documentation to facilitate design, development, and product verification testing of medical devices in collaboration with cross-functional engineering teams.
• Create and execute Quality Plans for Product Design and Development projects.
• Represent Quality Engineering in technical design and phase end reviews.
• Develop and perform Design of Experiments (DOE).
• Develop and validate test methods.
• Develop sampling plans and acceptance criteria for product testing and inspection methods using appropriate statistical techniques.
• Lead and/or participate in risk management activities, develop Risk Management Plans and Reports, perform Hazards Analysis and FMEAs (Failure Mode Effects Analysis) to evaluate and ensure product safety and functionality.
• Conduct and/or support root cause investigations, develop and implement corrective and preventative actions for quality system and product related nonconformances.
• Support quality system improvement initiatives and CAPA’s.
• Responsible for the assessment of technical standards, labeling and technical file requirements.
• Responsible for the assessment of component and system level specifications relative to customer needs and product performance specifications.
• Perform requirement flow down analysis on critical to quality product performance specifications down to components and process.
• Apply Design for Reliability and Manufacturability tools and techniques.
• Support for multiple projects, balancing priorities, and resources to meet both project and management expectations.
• Prepare reports required by the project or department management.
• Lead and/or participate in reviews and communications with customers.

Requirements

• Bachelor’s degree (STEM engineering discipline required) and 2 years of experience required; or a combination of education and relevant work experience.
• Experience in an engineering environment with mechanical, tool design, and manufacturing processes (medical device preferred).
• Knowledge of quality assurance and regulatory compliance including Quality System Standards and Regulations.
• Knowledge of product development processes and methods.
• Must be able to read, write and speak fluent English.

Qualifications

• Knowledge of systems engineering discipline, Technical Standards, Hazard Analysis and Failure Mode and Effects Analysis (FMEA), Qualification, Test Method, and Process Validation.
• Knowledge in the application of risk management.
• ASQ Certification preferred.

Benefits

• Training and career development
• Healthcare and well-being programs including medical, dental, vision, wellness and occupational health programs
• Paid Time Off
• 401(k) retirement savings with a company match

Pay

Salary Range: $89,000 to $108,000

We omitted About us company description. Should we include it? The instruction says include a section only when posting has real, specific content for it. We have About us content. But we don't have a matching heading. Could we use

About the company

? Not in list but maybe acceptable. However they said use

for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). The "e.g." suggests those are examples, not exhaustive. So we could add About the company. But they said do NOT repeat the job title as a heading (the page already shows it) and do NOT put Job ID / requisition numbers as headings — fold minor metadata into a short

or drop it. So we can add About the company. But we already have About the role for Position Summary. The About us is separate. Could we merge About us into About the role? Not ideal. Better to add a section About the company. Let's add:

About the company

For over three decades, Cirtec Medical has been a leading outsourcing partner for complex medical devices. We specialize in providing comprehensive solutions for Class II and III devices, from design and development to precision components and finished device assembly. Our expertise spans neuromodulation, implantable drug delivery, cardiac rhythm management, structural