Senior Design Assurance Engineer

Kaye/Bassman International; United States; On-site; USD 120,000 - 150,000; Full time

Job summary

An established industry player in medical device technology is seeking a Senior Design Assurance Engineer to ensure product quality and regulatory compliance. This role involves leading design control activities, supporting risk analysis, and maintaining technical documentation for innovative medical devices. Join a forward-thinking company that values cutting-edge innovation and excellence, where your expertise will contribute to enhancing patient care and shaping the future of medical technology. If you are passionate about making a difference in healthcare and have a strong background in design control, this opportunity is perfect for you.

Qualifications

• 8+ years of experience in engineering or quality roles within medical devices.
• Strong background in design control and risk management practices.

Responsibilities

• Lead product design control activities for new and sustaining product development.
• Support risk analysis and maintain technical design documentation.

Skills

Design Control Processes

Risk Management

Technical Documentation

Statistical Methods

Electro-mechanical Medical Devices

FDA Regulations

ISO Standards

Education

Bachelor's Degree in a Scientific Discipline

Tools

Minitab

Job description

1 week ago Be among the first 25 applicants

Kaye/Bassman International provided pay range

This range is provided by Kaye/Bassman International. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$120,000.00/yr - $150,000.00/yr

Additional compensation types

Annual Bonus and RSUs

Experienced Biotech & Pharma & Medical Device Regulatory Affairs Recruiter | Kaye/Bassman International

Company Overview:

Our client is a leading innovator in medical device technology, specializing in advanced laser-powered solutions that enhance patient care. With a commitment to cutting-edge innovation and excellence, they push the boundaries of medical advancements to improve healthcare outcomes. Join a company where innovation meets purpose—and help shape the future of medical technology.

Job Description:

The Senior Design Assurance Engineer will play a critical role in ensuring product quality and regulatory compliance through robust design control and risk management practices. This position will support new and sustaining product development efforts, collaborating cross-functionally to maintain the highest medical device design and safety standards.

Responsibilities:

• Leading product design control activities for both new and sustaining product development efforts.
• Supporting risk analysis, including design and process FMEA.
• Maintain technical design documentation, including design specifications, verification/validation protocols, and DFMEA/PFMEA.
• Assisting with Process/Design Validation and Verification activities, including software validation and IQ/OQ/PQ processes.
• Support Design Engineering in the creation of Design History and Technical Files.
• Coordinating with third-party test houses for compliance testing of products.
• Assisting the regulatory team with FDA, CE, and other regulatory submissions.
• Performing other essential duties as assigned.

Ideal Candidate:

• Bachelor's Degree in a scientific discipline or engineering discipline.
• At least 8 years of experience in an engineering or quality role within the medical device industry.
• 5 years of experience with engineering and development of Class II electro-mechanical medical devices.
• Strong experience with design control processes and design verification, including maintaining internal design controls.
• Ability to understand and manage product requirements, with a solid background in Risk Management.
• Experience with both disposable and capital equipment, particularly with complex disposables (e.g., electrochemical devices).
• Proven ability to maintain and structure design history throughout the development process.
• Experience with Design Controls and Risk Management practices.
• Familiarity with key regulations and standards (e.g., FDA QSR, ISO 13485, ISO 14971, IEC 60601, 60825, 62366, 62304) is preferred.
• Experience in the development phase of the product lifecycle, with hands-on experience in driving products through this phase.
• Experience supporting medical device compliance testing (e.g., EMC, EMI, IEC) with external test houses such as TUV and Intertek.
• Proven ability to maintain technical design documentation, including design specifications, verification/validation protocols, and DFMEA/PFMEA.
• Proficiency in advanced statistical methods (e.g., hypothesis testing, DOE, ANOVA, R&R studies, capability analysis, tolerance intervals, power/sample size calculations), with experience using statistical software tools like Minitab preferred.
• Experience with lasers and optical technologies is a plus but not required.
• Stability and focus, with the ability to remain steady in long-term projects and avoid frequent role changes.

Seniority level

Mid-Senior level

Employment type

Full-time

Job function

Design, Engineering, and Product Management

Industries

Medical Equipment Manufacturing