Senior Design Quality Assurance Engineer - Neuromodulation (NALU)
for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). So Schedule could be used for work mode details like hybrid, on-site days. We'll include Schedule section with that info. Benefits: Not explicitly listed besides relocation assistance maybe. There's mention of "core and optional employee benefits offered by Boston Scientific (BSC) – see www.bscbenefitsconnect.com". That's vague; not specific benefits. So we should not create Benefits section unless specific content. So omit Benefits. Skills: Not explicitly listed as separate; qualifications cover skills. Could combine into Requirements/Qualifications. We'll have sections: About the role, Responsibilities, Required Qualifications, Preferred Qualifications, Pay, Schedule. Possibly also "Work Mode" but we can put under Schedule. We must not repeat job title as heading. No Job ID/requisition numbers as headings; we can fold minor metadata into short
or drop it. So we can include Requisition ID in a paragraph maybe at top? But rule says do NOT put Job ID / requisition numbers as headings — fold minor metadata into a short
or drop it. So we can include a short paragraph with Requisition ID: 634783. Also Additional Location(s): N/A is filler; we should drop it. Diversity etc values are maybe fluff; could be omitted as boilerplate? It's not exactly boilerplate but could be considered values statement; but it's not a section; we could include as a paragraph maybe under About the role? However it's generic; but we can keep as part of About the role? The About the role paragraph already includes mission statement. The diversity list may be considered boilerplate; but it's not navigation/legal/EEO. Might keep as a short paragraph? The instruction: Remove cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate, duplicated lines, and application instructions. Diversity statement is not EEO; it's corporate values. Might keep but could be considered fluff. Safer to keep it as part of About the role? The About the role currently is: "At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions." That's already there. The diversity list is separate line: "Additional Location(s): N/A Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance". Actually the line seems misformed: "Additional Location(s): N/A Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance". Probably they meant Additional Location(s): N/A then a list of values. We'll drop Additional Location(s): N/A as filler. Keep the values? Might be considered boilerplate but not EEO. I'd keep them as a short paragraph under About the role maybe. But to be safe, I'd omit them as they are not substantive role-specific info. The instruction: "Prefer a few substantive sections over many thin ones." So we can omit. Now we need to preserve ALL substantive information; do not invent or summarize away detail. So we need to include all responsibilities bullet points, qualifications bullet points, etc. We need to format as HTML: use
for section headings. Use - for any list of duties/requirements/benefits. Use
for prose.
We must not include markdown fences.
Let's draft:
About the Role
The Senior Design Quality Assurance Engineer serves as a key Quality representative for the design, development, integration, and sustaining support of Neuromodulation medical-device systems. The role emphasizes external equipment, implantable leads, accessories, and surgical tools. This engineer partners with R&D, Systems Engineering, Manufacturing, Supplier Engineering, Regulatory Affairs, Clinical, Human Factors, and Project Management to build quality into products throughout the product life cycle. The position provides independent quality oversight of design controls, risk management, design verification and validation, design transfer, change assessment, and post-market feedback. This is a defined-term, hybrid position preferably based in Valencia, California (or California in general), with periodic on-site presence aligned to business and project needs.
Then Responsibilities:
Responsibilities
- Serve as the Design Quality Assurance representative for new-product development, integration, remediation, and sustaining projects involving implantable leads, accessories, and surgical tools.
- Support cross-functional teams through applicable design-control activities, ensuring user needs, design inputs, design outputs, design reviews, verification, validation, design transfer, and design changes are appropriately planned, executed, documented, and traceable.
- Provide quality oversight for risk-management activities throughout the product life cycle, including risk-management planning, preliminary hazard analysis, system and component hazard analyses, design FMEAs, use-related risk analysis, risk-control verification, residual-risk evaluation, and production/post-production feedback.
- Support design validation and human-factors activities to confirm that the finished device, accessories, labeling, packaging, and use workflows meet user needs and intended uses in representative use environments.
- Provide quality oversight for biocompatibility, sterilization, packaging, shelf-life, transport, electrical safety, electromagnetic compatibility, and active-implantable-device evidence, as applicable to the assigned products and changes.
- Support supplier and manufacturing quality activities that affect design requirements or product performance, including component qualification, supplier changes, nonconformance investigations, process validation, design transfer, and production-readiness reviews.
- Lead or support design-change assessments, CAPA, complaint investigations, nonconformance investigations, and field-signal evaluations by connecting post-market evidence to risk files, requirements, verification evidence, and potential corrective actions.
- Lead and support the review of post-market surveillance data, to evaluate product performance, identify emerging risks and trends, assess potential impacts to design requirements and risk management files, and determine the need for design, labeling, verification, validation, or corrective actions.
- Facilitate monthly Complaint Review Board (CRB) activities, including coordinating cross-functional contributors to develop meeting content, supporting pre-read review of clinical and medical safety escalation assessments, analyzing and trending complaint data, tracking and following up on action items, summarizing CRB decisions and outcomes, and distributing meeting materials and follow-up actions to stakeholders and participants.
Then Required Qualifications:
Required Qualifications
- Bachelor’s degree in biomedical, Mechanical, Electrical, Materials, Systems, Manufacturing Engineering, or another relevant engineering or scientific discipline.
- Minimum of 5 years of experience in Design Quality, Quality Engineering, Quality Systems, Post-Market Surveillance, Risk Management, CAPA, product development, or a related engineering function in the medical-device industry or another highly regulated environment.
- Experience reviewing technical documentation such as engineering drawings, specifications, tolerance analyses, test protocols/reports, FMEAs, hazard analyses, and validation evidence.
- Ability to apply risk-based judgment, independently challenge incomplete evidence, and translate quality and regulatory expectations into actionable project requirements.
- Clear written and verbal communication skills and the ability to collaborate effectively across R&D, Manufacturing, Supplier Engineering, Regulatory, Clinical, Human Factors, Marketing, and Project Management.
- Working knowledge of U.S. FDA Quality Management System Regulation and applicable design-control, complaint, CAPA, and reporting requirements, as well as applicable international regulatory requirements.
- Experience with ISO 13485, Medical devices quality management systems.
- Experience with ISO 14971, Medical-device risk management.
Preferred Qualifications:
Preferred Qualifications
- Master’s degree in engineering, scientific, or quality-related discipline.
- Direct experience with active implantable neuromodulation devices and associated external equipment, implantable leads, extensions, accessories, chargers, or surgical tools.
- Experience with lead and connector performance, mechanical fatigue, electrical integrity, biocompatibility, sterilization, packaging, shelf life, and simulated-use testing.
- Experience planning or reviewing Design Verification, Design Validation, reliability, test-method validation, Gauge R&R, and statistical sample-size rationales.
- Experience with supplier controls, component qualification, manufacturing transfer, process validation, complaint handling, CAPA, and external or regulatory audits.
- Experience supporting system-level risk management and traceability across multiple hardware subsystems and interfaces.
- Experience with IEC 62366-1, application of usability engineering to medical devices.
- Experience with IEC 60601-1, basic safety and essential performance of medical electrical equipment.
- ASQ Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), Six Sigma certification, or comparable quality credential.
Pay:
Pay
Minimum Salary: $89,200
Maximum Salary: $169,500
We could combine into one but rule: use
for prose. It's fine.
Schedule:
Schedule
Hybrid role based in Valencia or Carlsbad, CA; required on-site at least three (3) days per week. Relocation assistance may be available. Visa sponsorship not offered for this position.
We should also include Requisition ID maybe as a short paragraph before sections? Not required but could be included as metadata. The instruction: do NOT put Job ID / requisition numbers as headings — fold minor metadata into a short or drop it. So we can add a
Requisition ID: 634783
at top.
Also we might include a brief statement about location: "Preferably based in Valencia, California (or California in general)" already in About the role.
Check for any other substantive info: "Work Mode At Boston Scientific, we
for prose. We must not include markdown fences. Let's draft:
About the Role
The Senior Design Quality Assurance Engineer serves as a key Quality representative for the design, development, integration, and sustaining support of Neuromodulation medical-device systems. The role emphasizes external equipment, implantable leads, accessories, and surgical tools. This engineer partners with R&D, Systems Engineering, Manufacturing, Supplier Engineering, Regulatory Affairs, Clinical, Human Factors, and Project Management to build quality into products throughout the product life cycle. The position provides independent quality oversight of design controls, risk management, design verification and validation, design transfer, change assessment, and post-market feedback. This is a defined-term, hybrid position preferably based in Valencia, California (or California in general), with periodic on-site presence aligned to business and project needs.
Then Responsibilities:Responsibilities
- Serve as the Design Quality Assurance representative for new-product development, integration, remediation, and sustaining projects involving implantable leads, accessories, and surgical tools.
- Support cross-functional teams through applicable design-control activities, ensuring user needs, design inputs, design outputs, design reviews, verification, validation, design transfer, and design changes are appropriately planned, executed, documented, and traceable.
- Provide quality oversight for risk-management activities throughout the product life cycle, including risk-management planning, preliminary hazard analysis, system and component hazard analyses, design FMEAs, use-related risk analysis, risk-control verification, residual-risk evaluation, and production/post-production feedback.
- Support design validation and human-factors activities to confirm that the finished device, accessories, labeling, packaging, and use workflows meet user needs and intended uses in representative use environments.
- Provide quality oversight for biocompatibility, sterilization, packaging, shelf-life, transport, electrical safety, electromagnetic compatibility, and active-implantable-device evidence, as applicable to the assigned products and changes.
- Support supplier and manufacturing quality activities that affect design requirements or product performance, including component qualification, supplier changes, nonconformance investigations, process validation, design transfer, and production-readiness reviews.
- Lead or support design-change assessments, CAPA, complaint investigations, nonconformance investigations, and field-signal evaluations by connecting post-market evidence to risk files, requirements, verification evidence, and potential corrective actions.
- Lead and support the review of post-market surveillance data, to evaluate product performance, identify emerging risks and trends, assess potential impacts to design requirements and risk management files, and determine the need for design, labeling, verification, validation, or corrective actions.
- Facilitate monthly Complaint Review Board (CRB) activities, including coordinating cross-functional contributors to develop meeting content, supporting pre-read review of clinical and medical safety escalation assessments, analyzing and trending complaint data, tracking and following up on action items, summarizing CRB decisions and outcomes, and distributing meeting materials and follow-up actions to stakeholders and participants.
Required Qualifications
- Bachelor’s degree in biomedical, Mechanical, Electrical, Materials, Systems, Manufacturing Engineering, or another relevant engineering or scientific discipline.
- Minimum of 5 years of experience in Design Quality, Quality Engineering, Quality Systems, Post-Market Surveillance, Risk Management, CAPA, product development, or a related engineering function in the medical-device industry or another highly regulated environment.
- Experience reviewing technical documentation such as engineering drawings, specifications, tolerance analyses, test protocols/reports, FMEAs, hazard analyses, and validation evidence.
- Ability to apply risk-based judgment, independently challenge incomplete evidence, and translate quality and regulatory expectations into actionable project requirements.
- Clear written and verbal communication skills and the ability to collaborate effectively across R&D, Manufacturing, Supplier Engineering, Regulatory, Clinical, Human Factors, Marketing, and Project Management.
- Working knowledge of U.S. FDA Quality Management System Regulation and applicable design-control, complaint, CAPA, and reporting requirements, as well as applicable international regulatory requirements.
- Experience with ISO 13485, Medical devices quality management systems.
- Experience with ISO 14971, Medical-device risk management.
Preferred Qualifications
- Master’s degree in engineering, scientific, or quality-related discipline.
- Direct experience with active implantable neuromodulation devices and associated external equipment, implantable leads, extensions, accessories, chargers, or surgical tools.
- Experience with lead and connector performance, mechanical fatigue, electrical integrity, biocompatibility, sterilization, packaging, shelf life, and simulated-use testing.
- Experience planning or reviewing Design Verification, Design Validation, reliability, test-method validation, Gauge R&R, and statistical sample-size rationales.
- Experience with supplier controls, component qualification, manufacturing transfer, process validation, complaint handling, CAPA, and external or regulatory audits.
- Experience supporting system-level risk management and traceability across multiple hardware subsystems and interfaces.
- Experience with IEC 62366-1, application of usability engineering to medical devices.
- Experience with IEC 60601-1, basic safety and essential performance of medical electrical equipment.
- ASQ Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), Six Sigma certification, or comparable quality credential.
Pay
Minimum Salary: $89,200
Maximum Salary: $169,500
We could combine into onebut rule: use
for prose. It's fine. Schedule:
Schedule
Hybrid role based in Valencia or Carlsbad, CA; required on-site at least three (3) days per week. Relocation assistance may be available. Visa sponsorship not offered for this position.
We should also include Requisition ID maybe as a short paragraph before sections? Not required but could be included as metadata. The instruction: do NOT put Job ID / requisition numbers as headings — fold minor metadata into a shortor drop it. So we can add a
Requisition ID: 634783
at top. Also we might include a brief statement about location: "Preferably based in Valencia, California (or California in general)" already in About the role. Check for any other substantive info: "Work Mode At Boston Scientific, we