Senior Design Quality Engineer

Regulatory Toolkit; Bedford (MA); On-site; USD 102,000 - 164,000; Full time

Benefits offered by this job

PTO

401k match

HSA with company contribution

Stock purchase plan

Education reimbursement

Job summary

Philips in Bedford, MA is seeking a Senior Design Quality Engineer to lead the design control process for medical devices, overseeing inputs, verification, validation, and design transfer. You will drive process validation, CAPA, risk management, and PMS analytics to ensure regulatory and quality standards are met throughout the product lifecycle.

The role requires 5+ years in FDA-regulated environments, strong knowledge of ISO 14971, and a Bachelor’s in quality/engineering.

Qualifications

• 5+ years in FDA-regulated medical device environments focusing on design assurance and control.
• Deep knowledge of ISO 14971 risk management and QMS related to design controls.
• Experience with design verification/validation, CAPA and traceability.

Responsibilities

• Lead design control from inputs to verification, validation, and design transfer.
• Plan and execute process validation strategies using statistical tools.
• Draft and maintain quality plans for hardware, software, and systems.
• Perform risk management throughout the product lifecycle and lead PMS insights.
• Prepare for quality audits and inspections with comprehensive documentation.
• Manage CAPA processes and root cause analysis to prevent recurrence.

Skills

Regulatory experience

Design Assurance/Control

Risk Management ISO14971

QMS knowledge

CAPA processes

Data analytics

Post Market Surveillance

Education

Bachelor’s Degree in quality or engineering

ASQ-CQE or ISO Lead Auditor (desirable)

Tools

Audit tools

Quality documentation tools

Job description

Job Title

Senior Design Quality Engineer

Job Description

The Senior Design Quality Engineer is responsible for the entire design control process, from validating design inputs to overseeing verification, validation, and design transfer, as well as leading comprehensive process validation strategies to ensure new products and current portfolio meet quality and regulatory standards during production.

Your role:

• Plan and execute comprehensive process validation strategies using statistical tools to ensure seamless transition of new products to production, meeting quality and regulatory standards.
• Leads the entire design control process, from eliciting and validating design inputs to managing verification, validation, and smooth design transfer, ensuring rigorous adherence to regulatory and quality standards. Leads quality improvement projects by integrating quality, reliability, and Post Market Surveillance (PMS) insights into all stages of the product lifecycle, driving continuous enhancement of product quality and reliability.
• Drafts and upholds detailed quality engineering documents, including quality plans for hardware, software, and systems, ensuring all documentation is accurate, up-to-date, and compliant with regulatory requirements.
• Conducts thorough assessments of product and system designs, reviews performance data, and performs root cause analysis to identify and address quality deficiencies, ensuring the highest standards of design excellence.
• Validates critical design inputs such as usability, reliability, performance, manufacturability, and safety, ensuring alignment with both quality standards and regulatory requirements.
• Guides comprehensive risk management activities throughout the product lifecycle, ensuring potential risks are accurately identified, assessed, and effectively mitigated to uphold product safety and quality.
• Leverages post-market performance data to assess product effectiveness in the field, providing actionable feedback to manufacturing and design teams, and initiating corrective actions when necessary.
• Ensures preparation for quality audits and inspections, maintaining all necessary documentation and processes to demonstrate compliance with both internal and external quality standards.
• Records, manages, and executes CAPA processes, including problem identification, root cause analysis, and implementation of solutions to prevent recurrence and drive continuous improvement.
• Apply continuous improvement techniques to enhance quality practices, ensuring ongoing audit readiness and strict adherence to both internal and external quality standards throughout the product lifecycle.
• Builds and nurtures effective relationships with internal and external stakeholders, providing expert guidance and mentorship to cross-functional teams, ensuring alignment with quality standards and successful project milestones.
• Contributes to the development, implementation, and revision of QMS processes, including standard operating procedures (SOPs), work instructions, and quality manuals, ensuring their accuracy, clarity, and compliance with relevant standards.
• Previous experience documenting design, process and/or QMS changes and executing applicable gap assessments.

You're the right fit if:

• You have a minimum of 5+ years’ experience in FDA regulated medical device environments, with a focus on Design Assurance/Control, detailed knowledge of Risk Management (ISO 14971), and strong Understanding of all aspects of the QMS related to Design Controls.
• You have proven experience in Design Verification/Validation, Root Cause analysis and Defect Management.
• You have detailed experience in identifying, promoting, and supporting processes and design quality tools for use in tracking/preventing product defects, design traceability, and Design for Reliability.
• You have extensive experience in CAPA processes, including problem identification, root cause analysis, implementation of solutions to prevent recurrence and drive continuous improvement.
• You’re experienced in utilizing Quality, Reliability and Post Market Surveillance (PMS) insights/data analytics to lead continuous improvement throughout all stages of the product lifecycle.
• You’re able to share knowledge, insights regarding quality standards, and regulatory requirements.
• You have a minimum of a Bachelor’s Degree (Required), in Quality, Engineering or similar disciplines. ASQ-CQE, ISO 13485 training, ISO Lead Auditor certification-desired
• You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position.

How we work together:

We believe that we are better together than a part. For our Office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time (5 days per week) presence in the company’s facilities. Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations. This is an Office role.

About Philips:

We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality. healthcare that we all deserve. Do the work of your life to help improve the lives of others.

• Learn more about our business.
• Discover our rich and exciting history.
• Learn more about our purpose.
• Learn more about our culture.

Philips Transparency Details:

• The pay range for this position in Bedford, MA is $102,480 to $163,968.

The actual base pay offered may vary within the posted ranges depending on multiple factors including job-related knowledge/skills, experience, business needs, geographical location, and internal equity.

At Philips, it is not typical for an individual to be hired at or near the top end of the range for their role and compensation decisions are dependent upon the facts and circumstances of each case.

In addition, other compensation, such as an annual incentive bonus, sales commission or long-term incentives may be offered. Employees are eligible to participate in our comprehensive Philips Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and much more. Details about our benefits can be found here.

Additional Information:

• US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future.
• Company relocation benefits WILL NOT be provided for this position. For this position, you must reside in or within commuting distance to Bedford, MA.
• May require travel up to 10%.

#LI-PH1

This requisition is expected to stay active for 45 days but may close earlier if a successful candidate is selected or business necessity dictates. Interested candidates are encouraged to apply as soon as possible to ensure consideration.

Philips is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug-free workplace.